Browse FDA recalls

All 12,421 drug and device recall records from openFDA enforcement. A recall is a recorded FDA enforcement action — not proof any specific unit caused harm. Search by product or firm; open any recall for its lot and code details.

Showing the 500 most recent of 12,421 recalls — type to search all of them.

• UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPha

  McKesson · Drugs · 2026-01-16
  Class I
• Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC

  Haleon US Holdings LLC · Drugs · 2026-06-04
  Class I
• Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags

  Amneal Pharmaceuticals, LLC · Drugs · 2026-03-18
  Class I
• Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0

  B BRAUN MEDICAL INC · Drugs · 2026-04-28
  Class I
• MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Phar

  Wisconsin Pharmacal Company · Drugs · 2026-04-24
  Class I
• Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Wa

  Cardinal Health 200, LLC · Drugs · 2026-03-02
  Class I
• DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufacture

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-05-12
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYN

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA

  Boston Scientific Corporation · Devices · 2026-03-19
  Class I
• Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

  Insulet Corporation · Devices · 2026-03-12
  Class I
• Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B

  B Braun Medical Inc · Devices · 2026-05-06
  Class I
• Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• Atlan A350XL. Model Number: 8621600. anesthesia workstation

  Draeger, Inc. · Devices · 2026-05-07
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Impella RP Flex with SmartAssist. Product Code: 1000323.

  Abiomed, Inc. · Devices · 2026-01-27
  Class I
• NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007;

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

  Erbe USA Inc · Devices · 2026-02-12
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti

  Trividia Health, Inc. · Devices · 2026-02-06
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medl

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRING

  Omnicell, Inc. · Devices · 2026-03-25
  Class I
• Impella RP with SmartAssist. Product Code: 0046-0035.

  Abiomed, Inc. · Devices · 2026-01-27
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo

  American Contract Systems Inc · Devices · 2026-03-19
  Class I
• Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description

  Trividia Health, Inc. · Devices · 2026-02-06
  Class I
• CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K

  Merit Medical Systems, Inc. · Devices · 2026-02-13
  Class I
• Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

  Erbe USA Inc · Devices · 2026-02-12
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

  Ventec Life Systems, Inc. · Devices · 2026-03-25
  Class I
• ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C,

  Merit Medical Systems, Inc. · Devices · 2026-02-13
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10M

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Impella RP. Product Code: 0046-0011.

  Abiomed, Inc. · Devices · 2026-01-27
  Class I
• Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller

  Abiomed, Inc. · Devices · 2026-02-16
  Class I
• Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S

  Windstone Medical Packaging, Inc. · Devices · 2026-04-02
  Class I
• Pediatric care bed; Product Designation: KayserBett IDA;

  KAYSERBETTEN GMBH & CO. KG · Devices · 2026-05-04
  Class I
• Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat

  Olympus Corporation of the Americas · Devices · 2026-01-16
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S B

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF,

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151

  ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
  Class I
• Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as

  Boston Scientific Corporation · Devices · 2026-03-19
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POIN

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

  ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
  Class I
• NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-

  ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
  Class I
• Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa

  Olympus Corporation of the Americas · Devices · 2026-01-16
  Class I
• Halyard CATH LAB kit. Model Number: SACL75-01.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat

  Abiomed, Inc. · Devices · 2026-02-18
  Class I
• B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

  B Braun Medical Inc · Devices · 2026-03-19
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

  Merit Medical Systems, Inc. · Devices · 2026-02-13
  Class I
• NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description

  Trividia Health, Inc. · Devices · 2026-02-06
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152

  ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
  Class I
• RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-

  Bolton Medical Inc. · Devices · 2026-04-22
  Class I
• BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96

  Merit Medical Systems, Inc. · Devices · 2026-02-13
  Class I
• AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits

  North American Rescue LLC. · Devices · 2026-03-27
  Class I
• Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

  Navajo Manufacturing Company · Devices · 2026-02-18
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit S

  Medline Industries, LP · Devices · 2026-04-10
  Class I
• Halyard CATH LAB kit. Model Number: SACL75AM.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEA

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867

  B Braun Medical Inc · Devices · 2026-05-06
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupiv

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. M

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030

  Merit Medical Systems, Inc. · Devices · 2026-02-13
  Class I
• BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic

  Olympus Corporation of the Americas · Devices · 2026-01-16
  Class I
• Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory

  Baxter Healthcare Corporation · Devices · 2026-02-18
  Class I
• Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Descriptio

  Trividia Health, Inc. · Devices · 2026-02-06
  Class I
• B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

  B Braun Medical Inc · Devices · 2026-03-19
  Class I
• Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, mani

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

  B Braun Medical Inc · Devices · 2026-03-19
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

  Medical Action Industries, Inc. 306 · Devices · 2026-03-17
  Class I
• Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, mani

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Atlan A350. Model Number: 8211500. anesthesia workstation

  Draeger, Inc. · Devices · 2026-05-07
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

  Becton Dickinson & Company · Devices · 2026-04-27
  Class I
• NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

  B Braun Medical Inc · Devices · 2026-03-19
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.

  B Braun Medical Inc · Devices · 2026-03-19
  Class I
• LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

  Fresenius Kabi USA, LLC · Devices · 2026-05-06
  Class I
• Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

  AVID Medical, Inc. · Devices · 2026-03-13
  Class I
• Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, mani

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Automated Impella Controller (AIC); Product Code: 0042-0000-US;

  Abiomed, Inc. · Devices · 2026-04-20
  Class I
• Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

  Erbe USA Inc · Devices · 2026-02-12
  Class I
• Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

  Fresenius Kabi USA, LLC · Devices · 2026-05-06
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures

  Cook Incorporated · Devices · 2026-04-02
  Class I
• Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

  Intuitive Surgical, Inc. · Devices · 2026-03-11
  Class I
• B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

  B Braun Medical Inc · Devices · 2026-03-19
  Class I
• Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Nu

  Medline Industries, LP · Devices · 2026-03-24
  Class I
• Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, s

  Cook Incorporated · Devices · 2026-04-02
  Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

  Medline Industries, LP · Devices · 2026-02-27
  Class I
• Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

  Philips Respironics, Inc. · Devices · 2026-03-02
  Class I
• Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C

  B Braun Medical Inc · Devices · 2026-05-06
  Class I
• Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214

  Cook Incorporated · Devices · 2026-04-02
  Class I
• ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research

  Medinatura New Mexico, inc. · Drugs · 2025-12-12
  Class I
• UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UP

  Umary-USA.com · Drugs · 2025-05-21
  Class I
• Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San

  Green Lumber Holdings, LLC · Drugs · 2025-08-28
  Class I
• Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use S

  Church & Dwight Inc · Drugs · 2025-06-06
  Class I
• PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777

  DermaRite Industries, LLC · Drugs · 2025-07-17
  Class I
• Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by S

  Sandoz Inc · Drugs · 2025-06-27
  Class I
• 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, ND

  B BRAUN MEDICAL INC · Drugs · 2025-08-18
  Class I
• DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Sid

  DermaRite Industries, LLC · Drugs · 2025-07-17
  Class I
• Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland

  Dr. Reddy's Laboratories, Inc. · Drugs · 2025-03-13
  Class I
• ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.

  SAINI TRADE INC · Drugs · 2025-04-14
  Class I
• ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 8

  Medinatura New Mexico, inc. · Drugs · 2025-12-12
  Class I
• Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11

  Fresenius Kabi USA, LLC · Drugs · 2025-11-06
  Class I
• Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945

  Mohamed Hagar · Drugs · 2025-10-08
  Class I
• SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 3

  Ascent Consumer Products Inc. · Drugs · 2025-01-28
  Class I
• Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Ma

  Sandoz Inc · Drugs · 2025-06-27
  Class I
• Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.

  Amneal Pharmaceuticals, LLC · Drugs · 2025-04-17
  Class I
• DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) b

  DermaRite Industries, LLC · Drugs · 2025-07-17
  Class I
• ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance,

  EnShiShiXiangNiShangMaoYouXianGongSi · Drugs · 2025-05-06
  Class I
• SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-coun

  Ascent Consumer Products Inc. · Drugs · 2025-01-28
  Class I
• KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Indu

  DermaRite Industries, LLC · Drugs · 2025-07-17
  Class I
• POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest,

  ICU Medical, Inc. · Drugs · 2025-02-13
  Class I
• Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed

  Alvogen, Inc · Drugs · 2025-01-31
  Class I
• ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing

  Church & Dwight Inc · Drugs · 2025-06-06
  Class I
• Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single uni

  Provepharm Inc. · Drugs · 2025-01-21
  Class I
• POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical,

  Otsuka ICU Medical LLC · Drugs · 2025-10-29
  Class I
• PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Servi

  Central Admixture Pharmacy Services, Inc. · Drugs · 2025-02-20
  Class I
• UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UP

  Umary-USA.com · Drugs · 2025-05-21
  Class I
• Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)

  Amneal Pharmaceuticals, LLC · Drugs · 2025-06-02
  Class I
• Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle,

  One Source Nutrition, Inc, · Drugs · 2025-02-20
  Class I
• SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash Syste

  Ascent Consumer Products Inc. · Drugs · 2025-01-28
  Class I
• POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,

  Otsuka ICU Medical LLC · Drugs · 2025-10-29
  Class I
• ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, U

  SAINI TRADE INC · Drugs · 2025-04-14
  Class I
• Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC

  B BRAUN MEDICAL INC · Drugs · 2025-08-18
  Class I
• Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, L

  Unichem Pharmaceuticals USA Inc. · Drugs · 2025-08-27
  Class I
• MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

  StuffbyNainax · Drugs · 2025-12-15
  Class I
• NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGen

  GenoGenix LLC · Drugs · 2025-07-30
  Class I
• Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719

  IntegraDose Compounding Services LLC · Drugs · 2025-09-16
  Class I
• Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

  SAINI TRADE INC · Drugs · 2025-04-14
  Class I
• Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

  HANDELNINE GLOBAL LLC · Drugs · 2025-12-22
  Class I
• MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, U

  SAINI TRADE INC · Drugs · 2025-04-14
  Class I
• POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lak

  ICU Medical, Inc. · Drugs · 2025-02-13
  Class I
• ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216

  Church & Dwight Inc · Drugs · 2025-06-06
  Class I
• Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, U

  SAINI TRADE INC · Drugs · 2025-04-14
  Class I
• BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient P

  CareFusion 213, LLC · Drugs · 2025-02-14
  Class I
• SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China

  ANTHONY TRINH, 123Herbals LLC · Drugs · 2025-10-20
  Class I
• IDM-MICRO-R. Electrical wheelchair component.

  mo-Vis BVBA · Devices · 2025-07-10
  Class I
• Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr

  Abiomed, Inc. · Devices · 2025-06-23
  Class I
• NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

  NOXBOX LTD · Devices · 2025-09-09
  Class I
• CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO

  Smiths Medical ASD, Inc. · Devices · 2025-04-10
  Class I
• Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V

  Edwards Lifesciences, LLC · Devices · 2025-05-14
  Class I
• Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

  C.R. Bard Inc · Devices · 2025-04-17
  Class I
• DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

  Medtronic Perfusion Systems · Devices · 2025-08-06
  Class I
• IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

  IMPRIS Imaging Inc · Devices · 2025-09-30
  Class I
• MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Model Number L211 PROPONENT DR SL MRI Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

  Draeger, Inc. · Devices · 2025-06-16
  Class I
• Biograph mMR. Model Number: 10433372.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

  3M Company · Devices · 2025-04-10
  Class I
• WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel

  WHILL, INC. · Devices · 2025-12-29
  Class I
• GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron

  CareFusion 303, Inc. · Devices · 2025-09-11
  Class I
• GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Model Number S702, ALTRUA 2 DR SL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Whe

  Max Mobility LLC · Devices · 2025-08-12
  Class I
• Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014

  Medtronic Perfusion Systems · Devices · 2025-02-05
  Class I
• t:slim X2 Insulin Pump with Interoperable Technology

  Tandem Diabetes Care, Inc. · Devices · 2025-02-27
  Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel

  Max Mobility LLC · Devices · 2025-08-12
  Class I
• Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

  Baxter Healthcare Corporation · Devices · 2025-07-14
  Class I
• Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-04-22
  Class I
• Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen

  Tandem Diabetes Care, Inc. · Devices · 2025-07-21
  Class I
• IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intra

  Fresenius Kabi USA, LLC · Devices · 2025-05-12
  Class I
• WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-07-14
  Class I
• Servo-u Ventilator System. Model Number: 6688600.

  Maquet Critical Care AB · Devices · 2025-05-30
  Class I
• smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe

  Dexcom, Inc. · Devices · 2025-07-24
  Class I
• Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

  Draeger, Inc. · Devices · 2025-11-24
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product De

  Draeger, Inc. · Devices · 2025-09-09
  Class I
• Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606

  Medline Industries, LP · Devices · 2025-07-31
  Class I
• GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0

  Smiths Medical ASD, Inc. · Devices · 2025-04-10
  Class I
• Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-07-25
  Class I
• OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

  Abbott · Devices · 2025-09-10
  Class I
• Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• Model Number U128, VALITUDE CRT-P EL MRI

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S

  Olympus Corporation of the Americas · Devices · 2025-01-15
  Class I
• Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve

  SunMed Holdings, LLC · Devices · 2025-12-15
  Class I
• IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

  IMPRIS Imaging Inc · Devices · 2025-09-30
  Class I
• Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A

  Edwards Lifesciences, LLC · Devices · 2025-05-14
  Class I
• smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3

  Micro Therapeutics, Inc. · Devices · 2025-01-30
  Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

  Abbott · Devices · 2025-09-10
  Class I
• BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

  CareFusion 303, Inc. · Devices · 2025-02-18
  Class I
• Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co

  Abiomed, Inc. · Devices · 2025-08-20
  Class I
• Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re

  Ambu Inc. · Devices · 2025-07-09
  Class I
• Model Number L231, PROPONENT DR EL MRI Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L

  Medline Industries, LP · Devices · 2025-11-26
  Class I
• BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa

  Philips Respironics, Inc. · Devices · 2025-05-09
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl

  Centerline Biomedical Inc · Devices · 2025-04-11
  Class I
• CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-04-11
  Class I
• CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA

  Smiths Medical ASD, Inc. · Devices · 2025-04-10
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Model Number L101, ESSENTIO DR SL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ St

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pat

  Zyno Medical LLC · Devices · 2025-05-07
  Class I
• smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngosc

  Intersurgical Inc · Devices · 2025-06-17
  Class I
• HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

  Boston Scientific Corporation · Devices · 2025-12-19
  Class I
• Plum Duo Infusion System, List Number: 400020401

  ICU Medical, Inc. · Devices · 2025-07-11
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A

  Edwards Lifesciences, LLC · Devices · 2025-05-14
  Class I
• BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,

  CareFusion 303, Inc. · Devices · 2025-10-17
  Class I
• MAGNETOM Verio. Model Number: 10276755.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

  Medline Industries, LP · Devices · 2025-08-08
  Class I
• Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• MAGNETOM Lumina (DE). Model Number: 11344916.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

  Boston Scientific Corporation · Devices · 2025-12-19
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• CODMAN Disposable Perforator 11mm. Cranial Perforator.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-09-26
  Class I
• BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02

  Flexicare Medical (Dongguan) Ltd. · Devices · 2025-07-11
  Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

  Abbott · Devices · 2025-09-10
  Class I
• GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM

  Cerenovus Inc · Devices · 2025-10-02
  Class I
• Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

  Baxter Healthcare Corporation · Devices · 2025-08-04
  Class I
• Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product

  Conavi Medical Inc. · Devices · 2025-03-12
  Class I
• SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

  Draeger, Inc. · Devices · 2025-06-16
  Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; V

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

  Flexicare Medical (Dongguan) Ltd. · Devices · 2025-07-11
  Class I
• MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO

  Medline Industries, LP · Devices · 2025-11-26
  Class I
• Model Number L209 PROPONENT DR (VDD) SL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

  Flexicare Medical (Dongguan) Ltd. · Devices · 2025-07-11
  Class I
• CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111

  Smiths Medical ASD, Inc. · Devices · 2025-04-10
  Class I
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviro

  Fresenius Kabi USA, LLC · Devices · 2025-01-10
  Class I
• WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• DreamStation Auto BiPAP. Non-Continuous Ventilator.

  Philips Respironics, Inc. · Devices · 2025-06-30
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;

  GE Medical Systems China Co., Ltd. · Devices · 2025-11-14
  Class I
• Allura CV20; Catalog numbers: 722031

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).

  Fresenius Kabi USA, LLC · Devices · 2025-11-03
  Class I
• Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe

  Medline Industries, LP · Devices · 2025-07-31
  Class I
• ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device

  Olympus Corporation of the Americas · Devices · 2025-08-06
  Class I
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

  C.R. Bard Inc · Devices · 2025-04-17
  Class I
• Model Number U226, VISIONIST CRT-P EL

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a p

  Zyno Medical LLC · Devices · 2025-05-07
  Class I
• BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual)

  Percussionaire Corporation · Devices · 2025-09-17
  Class I
• Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding

  Abiomed, Inc. · Devices · 2025-10-01
  Class I
• EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• DreamStation Auto. Non-Continuous Ventilator.

  Philips Respironics, Inc. · Devices · 2025-06-30
  Class I
• smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8F

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

  Boston Scientific Corporation · Devices · 2025-12-19
  Class I
• GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic

  Given Imaging Ltd. · Devices · 2025-06-03
  Class I
• GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm

  ICU Medical, Inc. · Devices · 2025-10-02
  Class I
• ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the

  Draeger, Inc. · Devices · 2025-11-10
  Class I
• PROPONENT SR SL (Model L200)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

  Medline Industries, LP · Devices · 2025-08-21
  Class I
• MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N

  Dexcom, Inc. · Devices · 2025-07-24
  Class I
• Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an

  Olympus Corporation of the Americas · Devices · 2025-10-30
  Class I
• Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-

  Dexcom, Inc. · Devices · 2025-05-12
  Class I
• Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

  Flexicare Medical (Dongguan) Ltd. · Devices · 2025-07-11
  Class I
• MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pac

  Medline Industries, LP · Devices · 2025-11-26
  Class I
• Model Number U228, VISIONIST CRT-P EL MRI

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• MAGNETOM Vida Fit. Model Number: 11410481.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the b

  Draeger, Inc. · Devices · 2025-11-10
  Class I
• Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,

  Spectranetics Corporation · Devices · 2025-01-10
  Class I
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients

  Fresenius Kabi USA, LLC · Devices · 2025-11-14
  Class I
• Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09

  BALT USA, LLC · Devices · 2025-09-25
  Class I
• Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

  Baxter Healthcare Corporation · Devices · 2025-06-20
  Class I
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-21
  Class I
• Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.

  Smiths Medical ASD, Inc. · Devices · 2025-04-10
  Class I
• Model Number L221 PROPONENT DR EL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

  Medtronic Perfusion Systems · Devices · 2025-08-06
  Class I
• Extended Tip Applicator, 15 CM, Box of 5.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-05-22
  Class I
• Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF:

  Bard Peripheral Vascular Inc · Devices · 2025-02-05
  Class I
• GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• MAGNETOM Skyra fit. Model Number: 10849580.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1),

  Dexcom, Inc. · Devices · 2025-05-12
  Class I
• Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

  AVID Medical, Inc. · Devices · 2025-11-11
  Class I
• Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N

  Thoratec LLC · Devices · 2025-06-23
  Class I
• TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

  TMJ Solutions Inc · Devices · 2025-10-13
  Class I
• GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

  AVID Medical, Inc. · Devices · 2025-11-11
  Class I
• Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin

  Philips Respironics, Inc. · Devices · 2025-05-09
  Class I
• ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model

  Boston Scientific Corporation · Devices · 2025-07-24
  Class I
• SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PT

  Glycar SA Pty., Ltd. · Devices · 2025-10-09
  Class I
• Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product

  Draeger, Inc. · Devices · 2025-09-09
  Class I
• RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Mode

  Boston Scientific Corporation · Devices · 2025-07-24
  Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H

  Hamilton Medical AG · Devices · 2025-06-26
  Class I
• Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/

  Vyaire Medical · Devices · 2025-04-10
  Class I
• DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (C

  ZOLL Circulation, Inc. · Devices · 2025-03-04
  Class I
• Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect

  Abiomed, Inc. · Devices · 2025-09-16
  Class I
• Model Number L131, ESSENTIO DR EL MRI Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-ope

  WHILL, INC. · Devices · 2025-12-29
  Class I
• Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

  B BRAUN MEDICAL INC · Devices · 2025-07-09
  Class I
• ACCOLADE DR EL MRI (Model L331)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Numbe

  Medline Industries, LP · Devices · 2025-08-08
  Class I
• Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-04-22
  Class I
• ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the brea

  Draeger, Inc. · Devices · 2025-11-10
  Class I
• Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3

  Micro Therapeutics, Inc. · Devices · 2025-01-30
  Class I
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

  Boston Scientific Corporation · Devices · 2025-12-19
  Class I
• MAGNETOM Cima.X (DE). Model Number: 11647158.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump

  Baxter Healthcare Corporation · Devices · 2025-08-04
  Class I
• SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

  Draeger, Inc. · Devices · 2025-06-16
  Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRON

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Allura Xper FD20/15; Catalog numbers: 722058

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe

  Dexcom, Inc. · Devices · 2025-07-24
  Class I
• MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO

  Medline Industries, LP · Devices · 2025-11-26
  Class I
• Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model

  Dexcom, Inc. · Devices · 2025-08-28
  Class I
• FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr

  Abbott Diabetes Care, Inc. · Devices · 2025-11-24
  Class I
• smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Servo-n Ventilator System. Model Number: 6694800.

  Maquet Critical Care AB · Devices · 2025-05-30
  Class I
• smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Extended Tip Applicator, 8CM, Box of 5.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-05-22
  Class I
• Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A;

  Baxter Healthcare Corporation · Devices · 2025-04-07
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

  Bausch & Lomb Surgical, Inc. · Devices · 2025-03-27
  Class I
• Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1

  Cook Medical Incorporated · Devices · 2025-09-18
  Class I
• smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., R

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60

  CareFusion 303, Inc. · Devices · 2025-07-08
  Class I
• BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more

  Philips Respironics, Inc. · Devices · 2025-05-09
  Class I
• Convenience Kit, BREAST HERNIA DYNJ909125G

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• DreamStation Auto CPAP. Non-Continuous Ventilator.

  Philips Respironics, Inc. · Devices · 2025-06-30
  Class I
• Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36

  SunMed Holdings, LLC · Devices · 2025-05-15
  Class I
• Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

  Covidien · Devices · 2025-02-26
  Class I
• Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

  Baxter Healthcare Corporation · Devices · 2025-04-24
  Class I
• MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e

  Medline Industries, LP · Devices · 2025-07-31
  Class I
• Micro Joystick R-net. Electrical wheelchair component.

  mo-Vis BVBA · Devices · 2025-07-10
  Class I
• Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20

  B BRAUN MEDICAL INC · Devices · 2025-09-30
  Class I
• HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with Hear

  Thoratec LLC · Devices · 2025-03-13
  Class I
• Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Fl

  Getinge Usa Sales Inc · Devices · 2025-01-15
  Class I
• Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA,

  Covidien · Devices · 2025-05-21
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Whee

  Max Mobility LLC · Devices · 2025-08-12
  Class I
• Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

  Baxter Healthcare Corporation · Devices · 2025-06-20
  Class I
• GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L

  Medline Industries, LP · Devices · 2025-11-26
  Class I
• Model Number L121 ESSENTIO DR EL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PA

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate t

  Medical Depot Inc. · Devices · 2025-04-11
  Class I
• Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe

  Dexcom, Inc. · Devices · 2025-07-24
  Class I
• BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3),

  Flexicare Medical (Dongguan) Ltd. · Devices · 2025-07-11
  Class I
• GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000;

  GE Medical Systems China Co., Ltd. · Devices · 2025-11-14
  Class I
• Model Number L110, ESSENTIO SR SL MRI Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Produc

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

  Ethicon Endo-Surgery Inc · Devices · 2025-04-22
  Class I
• Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Ve

  SunMed Holdings, LLC · Devices · 2025-12-15
  Class I
• BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118

  Bard Access Systems, Inc. · Devices · 2025-03-11
  Class I
• Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110

  C.R. Bard Inc · Devices · 2025-04-17
  Class I
• Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc

  Baxter Healthcare Corporation · Devices · 2025-05-30
  Class I
• IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

  IMPRIS Imaging Inc · Devices · 2025-09-30
  Class I
• Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

  Baxter Healthcare Corporation · Devices · 2025-02-05
  Class I
• Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINN

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-07-25
  Class I
• EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Extended Tip Applicator 8CM, Box of 1.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-05-22
  Class I
• Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vess

  Medline Industries, LP · Devices · 2025-07-31
  Class I
• Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspira

  Qapel Medical Inc. · Devices · 2025-02-26
  Class I
• Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material

  Boston Scientific Corporation · Devices · 2025-07-07
  Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Model Number U225 VISIONIST CRT-P EL

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTF

  Glycar SA Pty., Ltd. · Devices · 2025-10-09
  Class I
• Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

  Baxter Healthcare Corporation · Devices · 2025-02-05
  Class I
• EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

  Baxter Healthcare Corporation · Devices · 2025-08-04
  Class I
• Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Softwa

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• Model Number L210 PROPONENT SR SL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• MAGNETOM Connectom.X. Model Number: 11371480.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

  SunMed Holdings, LLC · Devices · 2025-05-01
  Class I
• FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component

  Abbott Diabetes Care, Inc. · Devices · 2025-11-24
  Class I
• GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa

  Zyno Medical LLC · Devices · 2025-05-07
  Class I
• CODMAN Disposable Perforator, 14mm. Cranial perforator.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-04-11
  Class I
• Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Versio

  SunMed Holdings, LLC · Devices · 2025-12-15
  Class I
• GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• ACCOLADE DR SL (Model L301)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• MAGNETOM Prisma. Model Number: 10849582.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa

  Zyno Medical LLC · Devices · 2025-05-07
  Class I
• Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

  AVID Medical, Inc. · Devices · 2025-11-11
  Class I
• ACCOLADE DR EL (Model L321)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

  Abbott · Devices · 2025-09-10
  Class I
• Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile

  Baxter Healthcare Corporation · Devices · 2025-05-30
  Class I
• BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software

  CareFusion 303, Inc. · Devices · 2025-02-18
  Class I
• WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal acce

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• IDM-ARLITE-R. Electrical wheelchair component.

  mo-Vis BVBA · Devices · 2025-07-10
  Class I
• Model Number S701 ALTRUA 2 SR SL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Model Number L111, ESSENTIO DR SL MRI Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in cor

  Nipro Renal Soultions USA, Corporation · Devices · 2025-04-11
  Class I
• VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF:

  Ventec Life Systems, Inc. · Devices · 2025-02-03
  Class I
• *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

  Boston Scientific Corporation · Devices · 2025-12-19
  Class I
• OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA;

  Bausch & Lomb Surgical, Inc. · Devices · 2025-03-27
  Class I
• BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

  Flexicare Medical (Dongguan) Ltd. · Devices · 2025-07-11
  Class I
• Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A

  Edwards Lifesciences, LLC · Devices · 2025-05-14
  Class I
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S

  Dexcom, Inc. · Devices · 2025-07-24
  Class I
• ACCOLADE SR SL (Model L300)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-21
  Class I
• EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• CODMAN Disposable Perforator 9mm. Cranial Perforator.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-09-26
  Class I
• All-round Joystick R-net Light. Electrical wheelchair component.

  mo-Vis BVBA · Devices · 2025-07-10
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Pro

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. M

  Medline Industries, LP · Devices · 2025-07-31
  Class I
• Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• IDM-MULTI-R. Electrical wheelchair component.

  mo-Vis BVBA · Devices · 2025-07-10
  Class I
• Model Number U125, VALITUDE CRT-P EL

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Softw

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Produc

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended t

  Hamilton Medical AG · Devices · 2025-06-03
  Class I
• BIOGRAPH One (DE). Model Number: 11689172.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARD

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-21
  Class I
• Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2

  C.R. Bard Inc · Devices · 2025-04-17
  Class I
• Servo-u MR Ventilator System. Model Number: 6888800.

  Maquet Critical Care AB · Devices · 2025-05-30
  Class I
• Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 1920

  Alcon Research LLC · Devices · 2025-11-24
  Class I
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

  Boston Scientific Corporation · Devices · 2025-12-19
  Class I
• Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software V

  SunMed Holdings, LLC · Devices · 2025-12-15
  Class I
• Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A

  Edwards Lifesciences, LLC · Devices · 2025-05-14
  Class I
• Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-04-22
  Class I
• IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

  IMPRIS Imaging Inc · Devices · 2025-09-30
  Class I
• Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100

  C.R. Bard Inc · Devices · 2025-04-17
  Class I
• VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based

  Biosense Webster, Inc. · Devices · 2025-01-05
  Class I
• GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Allura Xper FD20/10; Catalog numbers: 722029

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Tandem Mobi Insulin Pump with Interoperable Technology

  Tandem Diabetes Care, Inc. · Devices · 2025-02-27
  Class I
• Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Des

  Thoratec LLC · Devices · 2025-06-23
  Class I
• WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transsepta

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow So

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-05-23
  Class I
• Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both

  Tandem Diabetes Care, Inc. · Devices · 2025-10-06
  Class I
• Model Number L100, ESSENTIO SR SL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are

  Cook Incorporated · Devices · 2025-05-15
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)

  Dexcom, Inc. · Devices · 2025-05-12
  Class I
• WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer,

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Allura Xper FD10C; Catalog number: 722001

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 016

  Boston Scientific Corporation · Devices · 2025-07-24
  Class I
• MAGNETOM Cima.X Upgrade. Model Number: 11689304.

  Siemens Medical Solutions USA, Inc · Devices · 2025-10-01
  Class I
• Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• ACCOLADE SR SL MRI (Model L310)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

  Draeger, Inc. · Devices · 2025-11-24
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the

  Draeger, Inc. · Devices · 2025-11-10
  Class I
• GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

  GE Medical Systems China Co., Ltd. · Devices · 2025-11-14
  Class I
• GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• Multi Joystick R-net. Electrical wheelchair component.

  mo-Vis BVBA · Devices · 2025-07-10
  Class I
• FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component

  Abbott Diabetes Care, Inc. · Devices · 2025-11-24
  Class I
• CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urina

  Calyxo, Inc. · Devices · 2025-02-19
  Class I
• WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal

  Boston Scientific Corporation · Devices · 2025-07-29
  Class I
• PROPONENT DR SL (Model L201)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product D

  Avanos Medical, Inc. · Devices · 2025-03-19
  Class I
• OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• Allura Xper FD20/20; Catalog numbers: 722038

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

  CareFusion 303, Inc. · Devices · 2025-07-08
  Class I
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-21
  Class I
• Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• MAGNETOM Verio Dot. Model Number: 10684333.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-28
  Class I
• HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

  Draeger, Inc. · Devices · 2025-06-16
  Class I
• Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicab

  Draeger, Inc. · Devices · 2025-03-12
  Class I
• smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., RE

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT20

  Baxter Healthcare Corporation · Devices · 2025-04-07
  Class I
• DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

  Medtronic Perfusion Systems · Devices · 2025-08-06
  Class I
• Model Number S722, ALTRUA 2 DR EL Pacemaker

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter

  Abbott · Devices · 2025-09-10
  Class I
• Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0),

  Dexcom, Inc. · Devices · 2025-05-12
  Class I
• smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6F

  Smiths Medical ASD, Inc. · Devices · 2025-02-13
  Class I
• NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

  NOXBOX LTD · Devices · 2025-09-09
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

  Olympus Corporation of the Americas · Devices · 2025-09-11
  Class I
• GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.

  GE Medical Systems China Co., Ltd. · Devices · 2025-03-21
  Class I
• FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component

  Abbott Diabetes Care, Inc. · Devices · 2025-11-24
  Class I
• Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019

  Medline Industries, LP · Devices · 2025-12-22
  Class I
• Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V

  Edwards Lifesciences, LLC · Devices · 2025-05-14
  Class I
• Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/

  Vyaire Medical · Devices · 2025-04-10
  Class I
• Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class I
• Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-24
  Class I
• MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pac

  Medline Industries, LP · Devices · 2025-11-26
  Class I
• ACCOLADE DR SL MRI (Model L311)

  Boston Scientific Corporation · Devices · 2025-08-20
  Class I
• Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230

  Medline Industries, LP · Devices · 2025-10-10
  Class I
• Weiner Boner Honey, 12g packet, 100% Organic Formula.

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199

  Supercore Products Group Inc. · Drugs · 2024-07-12
  Class I
• Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containi

  Endo USA, Inc. · Drugs · 2024-11-18
  Class I
• Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos

  Gilead Sciences, Inc. · Drugs · 2024-09-19
  Class I
• Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr.

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-04-08
  Class I
• Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC

  Aruba Aloe Balm N.V. · Drugs · 2024-03-23
  Class I
• Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pul

  AvKARE · Drugs · 2024-03-28
  Class I
• Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals,

  Azurity Pharmaceuticals, Inc. · Drugs · 2024-01-04
  Class I
• ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

  FA Online Inc · Drugs · 2024-02-12
  Class I
• Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl

  Baxter Healthcare Corporation · Drugs · 2024-08-01
  Class I
• Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial,

  Par Sterile Products LLC · Drugs · 2024-03-04
  Class I
• Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm I

  Aruba Aloe Balm N.V. · Drugs · 2024-03-23
  Class I
• Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

  SoloVital · Drugs · 2024-07-12
  Class I
• Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th

  Super Chill Products · Drugs · 2024-02-05
  Class I
• Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distri

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-04-08
  Class I
• Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 0854

  Bionpharma Inc. · Drugs · 2024-09-17
  Class I
• suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Sunt

  SYNCHRONICITY SPA INC, DBA SUNTE · Drugs · 2024-05-24
  Class I
• Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth

  Alcon Research LLC · Drugs · 2024-12-18
  Class I
• Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-co

  Amerisource Health Services LLC · Drugs · 2024-06-25
  Class I
• Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables US

  Hikma Injectables USA Inc · Drugs · 2024-04-29
  Class I
• Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma

  Astellas Pharma US Inc. · Drugs · 2024-12-23
  Class I
• ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapm

  Boulla LLC · Drugs · 2024-11-04
  Class I
• Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceu

  Sagent Pharmaceuticals · Drugs · 2024-05-28
  Class I
• Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib

  Aurobindo Pharma USA Inc · Drugs · 2024-07-11
  Class I
• Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Samurai-X Honey 6800, UPC 2 56891 27553 3.

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA

  SHOPPERS- PLAZA · Drugs · 2024-12-16
  Class I
• Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang,

  Buy-Herbal · Drugs · 2024-12-12
  Class I
• VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA

  Boulla LLC · Drugs · 2024-11-04
  Class I
• Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6

  Endo USA, Inc. · Drugs · 2024-11-18
  Class I
• ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Man

  Hikma Pharmaceuticals USA Inc. · Drugs · 2024-07-08
  Class I
• Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne

  Today The World · Drugs · 2024-02-06
  Class I
• HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas

  Stop Clopez Corp · Drugs · 2024-04-22
  Class I
• Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-30
  Class I
• PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.Peak

  Boulla LLC · Drugs · 2024-11-04
  Class I
• Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Dist

  Neptune Resources, LLC · Drugs · 2024-01-12
  Class I
• Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pha

  Revive Rx LLC dba Revive Rx Pharmacy · Drugs · 2024-04-20
  Class I
• ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zo

  Boulla LLC · Drugs · 2024-11-04
  Class I
• Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N

  Neptune Resources, LLC · Drugs · 2024-01-12
  Class I
• Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-30
  Class I
• Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyvill

  A-S Medication Solutions LLC · Drugs · 2024-06-21
  Class I
• SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Me

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. i

  Eugia US LLC · Drugs · 2024-02-15
  Class I
• Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed

  ENDO USA, Inc. · Drugs · 2024-12-20
  Class I
• Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 table

  Endo Pharmaceuticals, Inc. · Drugs · 2024-07-10
  Class I
• Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.

  Supercore Products Group Inc. · Drugs · 2024-07-12
  Class I
• STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street,

  Homeocare Laboratories, Inc. · Drugs · 2024-06-05
  Class I
• Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6

  Endo USA, Inc. · Drugs · 2024-11-18
  Class I
• Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergr

  Staska Pharmaceuticals, Inc. · Drugs · 2024-09-30
  Class I
• TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Ph

  Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Drugs · 2024-02-01
  Class I
• Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N.

  Neptune Resources, LLC · Drugs · 2024-01-12
  Class I
• RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Dis

  Integrity Products · Drugs · 2024-02-01
  Class I
• Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containin

  Endo USA, Inc. · Drugs · 2024-11-18
  Class I
• To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: I

  Integrity Products · Drugs · 2024-02-01
  Class I
• FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

  GNMart LLC · Drugs · 2024-12-12
  Class I
• libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceutic

  Sagent Pharmaceuticals · Drugs · 2024-05-28
  Class I
• Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:

  Astellas Pharma US Inc. · Drugs · 2024-12-23
  Class I
• 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-0

  B. Braun Medical Inc · Drugs · 2024-07-24
  Class I
• Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2024-03-21
  Class I
• SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA

  Today The World · Drugs · 2024-02-06
  Class I
• Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

  MAIN PRODUCTS INC · Drugs · 2024-07-18
  Class I
• Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengk

  123Herbals · Drugs · 2024-09-18
  Class I
• Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Neva

  Today The World · Drugs · 2024-02-06
  Class I
• GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.

  Pyramids Wholesale Inc. · Drugs · 2024-03-19
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int

  ROUTE 92 MEDICAL INC · Devices · 2024-03-08
  Class I
• PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Numb

  Boston Scientific Corporation · Devices · 2024-12-12
  Class I
• Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de

  ROUTE 92 MEDICAL INC · Devices · 2024-03-08
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class I
• stay-safe /Luer Lock Adapter 4 in

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-01-23
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Produ

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P

  Percussionaire Corporation · Devices · 2024-12-23
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System

  Abbott Diabetes Care, Inc. · Devices · 2024-07-24
  Class I
• McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only

  Covidien · Devices · 2024-07-09
  Class I
• Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

  Baxter Healthcare Corporation · Devices · 2024-08-20
  Class I
• GE Heathcare Giraffe OmniBed; neo natal incubator

  DATEX--OHMEDA, INC. · Devices · 2024-09-03
  Class I
• CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

  Datascope Corp. · Devices · 2024-08-08
  Class I
• CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following u

  Smiths Medical ASD Inc. · Devices · 2024-02-27
  Class I
• Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-12-31
  Class I
• Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• Mojo 2 Full Face AAV Non Vented Mask, All Sizes

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

  SonarMed Inc · Devices · 2024-03-25
  Class I
• Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design

  Olympus Corporation of the Americas · Devices · 2024-12-18
  Class I
• BiPAP V30 Auto Ventilator, Part Number 1111178

  Philips Respironics, Inc. · Devices · 2024-03-26
  Class I
• Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for i

  Fresenius Kabi USA, LLC · Devices · 2024-08-30
  Class I
• VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

  Maquet Cardiovascular, LLC · Devices · 2024-09-20
  Class I
• Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class I
• LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

  Fresenius Kabi USA, LLC · Devices · 2024-03-07
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

  SonarMed Inc · Devices · 2024-03-21
  Class I
• AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F

  Vyaire Medical · Devices · 2024-01-10
  Class I
• BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ

  Hologic, Inc · Devices · 2024-03-13
  Class I
• a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDI

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

  SonarMed Inc · Devices · 2024-03-21
  Class I
• MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1

  Medtronic MiniMed, Inc. · Devices · 2024-07-31
  Class I
• Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

  Thoratec Corp. · Devices · 2024-03-01
  Class I
• Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

  ARROW INTERNATIONAL Inc. · Devices · 2024-04-29
  Class I
• stay-safe /Luer Lock Catheter Ext. 18 in

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-01-23
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

  Outset Medical, Inc. · Devices · 2024-03-06
  Class I
• BioZorb Marker. Radiographic soft tissue marker.

  Hologic, Inc · Devices · 2024-10-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

  Fresenius Kabi USA, LLC · Devices · 2024-12-06
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

  Trokamed GmbH · Devices · 2024-11-27
  Class I
• Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Val

  Percussionaire Corporation · Devices · 2024-08-21
  Class I
• Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

  Percussionaire Corporation · Devices · 2024-08-21
  Class I
• Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used

  Vyaire Medical, Inc. · Devices · 2024-04-08
  Class I
• HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigationa

  Thoratec Corp. · Devices · 2024-02-19
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

  Smiths Medical ASD Inc. · Devices · 2024-02-07
  Class I
• StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati

  Nova Biomedical Corporation · Devices · 2024-11-20
  Class I
• AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017

  Vyaire Medical · Devices · 2024-01-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used

  Medtronic Neurosurgery · Devices · 2024-01-22
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-12-16
  Class I
• Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati

  Breas Medical, Inc. · Devices · 2024-07-25
  Class I
• Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatio

  Draeger Medical, Inc. · Devices · 2024-10-15
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Impella RP Flex with SmartAssist; Product Number: 1000323;

  Abiomed, Inc. · Devices · 2024-12-12
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-26
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In

  Baxter Healthcare Corporation · Devices · 2024-05-30
  Class I
• Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient

  Megadyne Medical Products, Inc. · Devices · 2024-06-17
  Class I
• nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with th

  Nuwellis Inc · Devices · 2024-12-11
  Class I
• AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005

  Vyaire Medical · Devices · 2024-01-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Componen

  Draeger Medical, Inc. · Devices · 2024-10-15
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/L

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAID

  Medtronic Neurosurgery · Devices · 2024-11-01
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number

  ICU Medical Inc · Devices · 2024-05-07
  Class I
• Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• stay-safe /Luer Catheter Ext. 6 in

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-01-23
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe

  Medos International Sarl · Devices · 2024-02-02
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• iQ 2 Nasal Vented Mask

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• Mojo 2 Full Face Non Vented Mask, All Sizes

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ket

  Nova Biomedical Corporation · Devices · 2024-11-20
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S

  Smiths Medical ASD Inc. · Devices · 2024-07-16
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to

  ROi CPS LLC · Devices · 2024-12-26
  Class I
• Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

  Trokamed GmbH · Devices · 2024-11-27
  Class I
• Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

  Smiths Medical ASD Inc. · Devices · 2024-05-31
  Class I
• Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio

  ROUTE 92 MEDICAL INC · Devices · 2024-03-08
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Pro

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi

  Percussionaire Corporation · Devices · 2024-09-16
  Class I
• Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

  OptumHealth Care Solutions LLC · Devices · 2024-04-18
  Class I
• Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Micro

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

  Boston Scientific Corporation · Devices · 2024-12-12
  Class I
• AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

  SonarMed Inc · Devices · 2024-03-21
  Class I
• HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2

  Thoratec Corp. · Devices · 2024-02-19
  Class I
• Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2

  Philips Respironics, Inc. · Devices · 2024-07-16
  Class I
• Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:

  Draeger Medical, Inc. · Devices · 2024-10-15
  Class I
• Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2

  Vyaire Medical · Devices · 2024-01-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111

  Philips Respironics, Inc. · Devices · 2024-03-26
  Class I
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. f

  Fresenius Kabi USA, LLC · Devices · 2024-08-01
  Class I
• LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010

  Boston Scientific Corporation · Devices · 2024-02-20
  Class I
• Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)

  Synergetics Inc · Devices · 2024-06-12
  Class I
• smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

  Smiths Medical ASD Inc. · Devices · 2024-02-07
  Class I
• Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes

  Baxter Healthcare Corporation · Devices · 2024-05-29
  Class I
• 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3.

  Thoratec Corp. · Devices · 2024-01-03
  Class I
• Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3

  Baxter Healthcare Corporation · Devices · 2024-09-12
  Class I
• smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item

  Smiths Medical ASD Inc. · Devices · 2024-06-07
  Class I
• CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

  Datascope Corp. · Devices · 2024-08-08
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

  ARROW INTERNATIONAL Inc. · Devices · 2024-04-29
  Class I
• smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll

  Smiths Medical ASD Inc. · Devices · 2024-06-07
  Class I
• GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART

  DeRoyal Industries Inc · Devices · 2024-02-13
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Micros

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco re

  Kinova Inc · Devices · 2024-08-22
  Class I
• smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll

  Smiths Medical ASD Inc. · Devices · 2024-06-07
  Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel

  Max Mobility LLC · Devices · 2024-12-20
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy

  Philips North America Llc · Devices · 2024-06-05
  Class I
• MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec

  Avanos Medical, Inc. · Devices · 2024-01-16
  Class I
• RMU-2000 Automated Chest Compression Device

  Defibtech, LLC · Devices · 2024-07-12
  Class I
• Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

  Cardinal Health 200, LLC · Devices · 2024-09-25
  Class I
• Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

  Tandem Diabetes Care, Inc. · Devices · 2024-03-05
  Class I
• ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb

  Inari Medical - Oak Canyon · Devices · 2024-07-19
  Class I
• CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

  Datascope Corp. · Devices · 2024-08-08
  Class I
• Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

  ARROW INTERNATIONAL Inc. · Devices · 2024-04-29
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

  Vyaire Medical · Devices · 2024-01-10
  Class I
• VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984;

  Biomerieux Inc · Devices · 2024-03-14
  Class I
• Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device

  Baxter Healthcare Corporation · Devices · 2024-08-20
  Class I
• Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev

  ROUTE 92 MEDICAL INC · Devices · 2024-03-08
  Class I
• Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used

  Medtronic Neurosurgery · Devices · 2024-01-22
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The D

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG

  ZOLL Medical Corporation · Devices · 2024-04-30
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111

  Philips Respironics, Inc. · Devices · 2024-04-01
  Class I
• Mojo Non Vented Full Face Mask with Headgear, All Sizes

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Num

  Boston Scientific Corporation · Devices · 2024-12-12
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F

  Zyno Medical LLC · Devices · 2024-09-13
  Class I
• Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

  Mercury Enterprises, Inc. dba Mercury Medical · Devices · 2024-08-30
  Class I
• Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne

  Elekta Instrument AB · Devices · 2024-09-25
  Class I
• BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11

  Philips Respironics, Inc. · Devices · 2024-03-26
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -

  Avanos Medical, Inc. · Devices · 2024-01-16
  Class I
• AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2

  Vyaire Medical · Devices · 2024-01-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

  Smiths Medical ASD Inc. · Devices · 2024-05-31
  Class I
• Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

  Abiomed, Inc. · Devices · 2024-05-31
  Class I
• Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device

  Baxter Healthcare Corporation · Devices · 2024-08-20
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Produ

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

  Trokamed GmbH · Devices · 2024-11-27
  Class I
• Trilogy Evo Universal Ventilator, Model No. DS2000X11B

  Philips Respironics, Inc. · Devices · 2024-07-16
  Class I
• Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)

  Synergetics Inc · Devices · 2024-06-12
  Class I
• Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye

  Synergetics Inc · Devices · 2024-06-12
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Cod

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 105

  Mercury Enterprises, Inc. dba Mercury Medical · Devices · 2024-12-10
  Class I
• Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E

  Medtronic Neurosurgery · Devices · 2024-01-22
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i

  ROUTE 92 MEDICAL INC · Devices · 2024-03-08
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode

  Megadyne Medical Products, Inc. · Devices · 2024-06-17
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy

  Philips North America Llc · Devices · 2024-06-05
  Class I
• AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001

  Vyaire Medical · Devices · 2024-01-10
  Class I
• JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

  JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD · Devices · 2024-12-09
  Class I
• Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data recei

  Braemar Manufacturing, LLC · Devices · 2024-12-18
  Class I
• ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Numb

  Boston Scientific Corporation · Devices · 2024-12-12
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,

  Vyaire Medical · Devices · 2024-01-10
  Class I
• stay-safe /Luer Lock Catheter Ext. 12 in

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-01-23
  Class I
• ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-042

  ARROW INTERNATIONAL Inc. · Devices · 2024-02-12
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Dis

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

  Boston Scientific Corporation · Devices · 2024-10-10
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Whee

  Max Mobility LLC · Devices · 2024-12-20
  Class I
• Mojo 2 Full Face Vented Mask, All Sizes

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MM

  Medtronic MiniMed, Inc. · Devices · 2024-07-31
  Class I
• Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List N

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Phantom 2 Nasal Vented Mask

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

  Boston Scientific Corporation · Devices · 2024-12-12
  Class I
• Plum 360/A+ spare batteries. Item Number: SUB0000864.

  ICU Medical Inc · Devices · 2024-05-07
  Class I
• Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device

  Baxter Healthcare Corporation · Devices · 2024-08-20
  Class I
• Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, I

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-12-31
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANG

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50

  Megadyne Medical Products, Inc. · Devices · 2024-05-08
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Mojo Full Face with Headgear, All Sizes

  SleepNet Corporation · Devices · 2024-03-01
  Class I
• LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• stay-safe /Safe Lock Catheter Ext. 12 in

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-01-23
  Class I
• Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB56

  Covidien · Devices · 2024-06-24
  Class I
• Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6

  Elekta Instrument AB · Devices · 2024-03-15
  Class I
• Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)

  Synergetics Inc · Devices · 2024-06-12
  Class I
• Amingo. OUS only.

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only

  Covidien · Devices · 2024-07-09
  Class I
• Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

  Trokamed GmbH · Devices · 2024-11-27
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Cod

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation

  Draeger Medical, Inc. · Devices · 2024-10-15
  Class I
• Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class I
• Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion

  ICU Medical, Inc. · Devices · 2024-10-22
  Class I
• Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT10

  InfuTronix LLC · Devices · 2024-02-21
  Class I
• NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.

  Medtronic Xomed, Inc. · Devices · 2024-06-24
  Class I
• Impella RP with SmartAssist; Product Number: 0046-0035;

  Abiomed, Inc. · Devices · 2024-12-12
  Class I
• Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E

  Philips Respironics, Inc. · Devices · 2024-07-16
  Class I
• ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

  Boston Scientific Corporation · Devices · 2024-12-12
  Class I
• Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposab

  Kirwan Surgical Products, LLC · Devices · 2024-11-14
  Class I
• Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

  B Braun Medical Inc · Devices · 2024-08-07
  Class I
• Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Ster

  Medtronic Neurosurgery · Devices · 2024-01-22
  Class I
• microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode o

  FHC, Inc. · Devices · 2024-10-04
  Class I
• Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

  Boston Scientific Corporation · Devices · 2024-02-12
  Class I
• VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive

  Maquet Cardiovascular, LLC · Devices · 2024-12-09
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/Li

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List N

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

  Datascope Corp. · Devices · 2024-08-08
  Class I
• Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in min

  Maquet Cardiovascular, LLC · Devices · 2024-12-09
  Class I
• Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is

  ICU Medical Inc · Devices · 2024-05-07
  Class I
• MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1

  Medtronic MiniMed, Inc. · Devices · 2024-07-31
  Class I
• Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110

  Philips Respironics, Inc. · Devices · 2024-10-07
  Class I
• Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• Inspire Model 3028, IV Implantable Pulse Generator

  Inspire Medical Systems Inc. · Devices · 2024-05-16
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Ventilator HAMILTON-C6, PN: 160021

  Hamilton Medical AG · Devices · 2024-05-15
  Class I
• Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusabl

  Megadyne Medical Products, Inc. · Devices · 2024-06-17
  Class I
• Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-12-16
  Class I
• Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is

  Baxter Healthcare Corporation · Devices · 2024-10-16
  Class I
• Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid fo

  Medtronic Navigation, Inc. · Devices · 2024-03-26
  Class I
• Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Cod

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

  Philips Respironics, Inc. · Devices · 2024-03-19
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: I

  Smiths Medical ASD Inc. · Devices · 2024-02-27
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

  Baxter Healthcare Corporation · Devices · 2024-05-30
  Class I
• paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

  Smiths Medical ASD Inc. · Devices · 2024-05-31
  Class I
• Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

  Thoratec Corp. · Devices · 2024-03-01
  Class I
• Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD I

  InfuTronix LLC · Devices · 2024-02-21
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANG

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Dr¿ger Perseus A500 Anesthesia Workstation

  Draeger Medical, Inc. · Devices · 2024-03-20
  Class I
• Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t

  Datex-Ohmeda, Inc. · Devices · 2024-07-12
  Class I
• SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achiev

  Philips North America Llc · Devices · 2024-06-05
  Class I
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-21
  Class I
• Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY V

  Medtronic Neurosurgery · Devices · 2024-11-01
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter

  Nova Biomedical Corporation · Devices · 2024-11-20
  Class I
• GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

  DATEX--OHMEDA, INC. · Devices · 2024-09-03
  Class I
• Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN

  Thoratec Corp. · Devices · 2024-05-08
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used

  Ventec Life Systems, Inc. · Devices · 2024-01-09
  Class I
• CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous,

  Smiths Medical ASD Inc. · Devices · 2024-02-27
  Class I
• Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Ster

  Medtronic Neurosurgery · Devices · 2024-01-22
  Class I
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter

  Boston Scientific Corporation · Devices · 2024-03-21
  Class I
• Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

  Smiths Medical ASD Inc. · Devices · 2024-05-31
  Class I
• PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO S

  Smiths Medical ASD Inc. · Devices · 2024-05-29
  Class I
• Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class I
• Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40

  Getinge Usa Sales Inc · Devices · 2024-05-01
  Class I
• AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004

  Vyaire Medical · Devices · 2024-01-10
  Class I
• ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA

  Biomic Sciences, LLC dba ION Intelligence of Nature · Drugs · 2023-09-29
  Class I
• ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intraveno

  Exela Pharma Sciences LLC · Drugs · 2023-10-18
  Class I
• Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distrib

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium

  Lupin Pharmaceuticals Inc. · Drugs · 2023-06-23
  Class I
• Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distribu

  Nanomaterials Discovery Corporation · Drugs · 2023-02-14
  Class I
• LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, S

  Cardinal Health Inc. · Drugs · 2023-10-31
  Class I
• Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use

  Pfizer Inc. · Drugs · 2023-12-21
  Class I
• VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-12-28
  Class I
• FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 1379

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-12-28
  Class I
• CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Sing

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Pr

  Volt Candy Wholesale Club · Drugs · 2023-02-13
  Class I
• 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector

  Pfizer Inc. · Drugs · 2023-10-02
  Class I
• Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceutica

  InvaGen Pharmaceuticals, Inc. · Drugs · 2023-11-17
  Class I
• Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark B

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-12-28
  Class I
• LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL

  Cardinal Health Inc. · Drugs · 2023-10-31
  Class I
• Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 c

  SUGARMDS LLC · Drugs · 2023-11-08
  Class I
• Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribut

  Global Pharma Healthcare Private Limited · Drugs · 2023-01-30
  Class I
• Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc

  PFIZER · Drugs · 2023-12-21
  Class I
• Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10

  KVK-Tech, Inc. · Drugs · 2023-09-20
  Class I
• CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 1379

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-12-28
  Class I
• Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 m

  Global Pharma Healthcare Private Limited · Drugs · 2023-01-30
  Class I
• 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Ca

  Exela Pharma Sciences LLC · Drugs · 2023-10-18
  Class I
• G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal

  Novis PR, LLC dba Kramer Novis · Drugs · 2023-04-20
  Class I
• PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Comp

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-12-28
  Class I
• Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bott

  Pharmedica USA, LLC · Drugs · 2023-02-14
  Class I
• Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distr

  Haleon US Holdings LLC · Drugs · 2023-12-26
  Class I
• CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL O

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, St

  Cardinal Health Inc. · Drugs · 2023-10-31
  Class I
• 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a

  Pfizer Inc. · Drugs · 2023-10-02
  Class I
• Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2023-10-23
  Class I
• Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de

  Botanical Be · Drugs · 2023-10-20
  Class I
• CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry

  Church & Dwight Inc · Drugs · 2023-09-08
  Class I
• PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Com

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-12-28
  Class I
• Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL O

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 9930

  Meta Herbal · Drugs · 2023-11-29
  Class I
• Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Hea

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

  Gadget Island, Inc · Drugs · 2023-04-26
  Class I
• Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98

  Gadget Island, Inc · Drugs · 2023-04-26
  Class I
• LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by:

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.

  Marlex Pharmaceuticals, Inc. · Drugs · 2023-08-25
  Class I
• CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (ND

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livoni

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2023-10-31
  Class I
• Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc.,

  Camber Pharmaceuticals Inc. · Drugs · 2023-03-13
  Class I
• Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx o

  Cipla USA, Inc. · Drugs · 2023-06-27
  Class I
• SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM

  Novartis Pharmaceuticals Corp. · Drugs · 2023-09-08
  Class I
• LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed

  Cardinal Health Inc. · Drugs · 2023-10-31
  Class I
• WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar

  Hua Da Trading, Inc. dba Wefun Inc. · Drugs · 2023-08-25
  Class I
• EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single P

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health D

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only

  Pfizer Inc. · Drugs · 2023-12-21
  Class I
• Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8

  Haleon US Holdings LLC · Drugs · 2023-12-26
  Class I
• Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Co

  Botanical Be · Drugs · 2023-10-20
  Class I
• Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceutic

  Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Drugs · 2023-12-21
  Class I
• Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed B

  Global Pharma Healthcare Private Limited · Drugs · 2023-02-24
  Class I
• BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc.,

  Scynexis, Inc. · Drugs · 2023-09-25
  Class I
• NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.

  Gadget Island, Inc · Drugs · 2023-04-26
  Class I
• Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby L

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL S

  Pfizer Inc. · Drugs · 2023-12-21
  Class I
• Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distr

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon

  Jarman's Midwest Cleaning Systems, Inc. · Drugs · 2023-03-27
  Class I
• LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By

  Cardinal Health Inc. · Drugs · 2023-10-31
  Class I
• Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Ai

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limit

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2023-05-31
  Class I
• Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bott

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM

  Dr. Berne's Whole Health Products · Drugs · 2023-08-26
  Class I
• LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Dist

  Cardinal Health Inc. · Drugs · 2023-10-31
  Class I
• Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUG

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2023-10-31
  Class I
• TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: In

  Insight Pharmaceuticals Corporation · Drugs · 2023-11-22
  Class I
• THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions

  Noah's Wholesale LLC · Drugs · 2023-10-16
  Class I
• VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutica

  Bayer Healthcare Pharmaceuticals Inc. · Drugs · 2023-11-06
  Class I
• Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle,

  Jarman's Midwest Cleaning Systems, Inc. · Drugs · 2023-03-27
  Class I
• Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, t

  APG SEVEN, INC · Drugs · 2023-08-03
  Class I
• Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to U

  Exela Pharma Sciences LLC · Drugs · 2023-10-18
  Class I
• Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Dist

  VistaPharm LLC · Drugs · 2023-10-18
  Class I
• Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44

  Botanical Be · Drugs · 2023-10-20
  Class I
• Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rit

  Kilitch Healthcare India Limited · Drugs · 2023-11-13
  Class I
• SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM H

  Novartis Pharmaceuticals Corporation · Drugs · 2023-11-22
  Class I
• 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector

  Pfizer Inc. · Drugs · 2023-10-02
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

  Covidien LP · Devices · 2023-06-28
  Class I
• ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

  Olympus Corporation of the Americas · Devices · 2023-10-12
  Class I
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629

  Covidien LP · Devices · 2023-06-28
  Class I
• Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

  Fresenius Kabi USA, LLC · Devices · 2023-11-29
  Class I
• MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• TRACH KIT W/HYDROGEN & SALI

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000

  Wipro GE Healthcare Private Ltd. · Devices · 2023-12-26
  Class I
• Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a

  Abbott Medical · Devices · 2023-07-18
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883

  Covidien LP · Devices · 2023-06-28
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product

  Abbott Medical · Devices · 2023-07-18
  Class I
• CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack

  Cardinal Health 200, LLC · Devices · 2023-09-20
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr

  Hamilton Medical, Inc. · Devices · 2023-06-15
  Class I
• CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

  Datascope Corp. · Devices · 2023-07-31
  Class I
• MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• VentStar Basic (P)180, MP00351

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup

  Hamilton Medical, Inc. · Devices · 2023-06-15
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP

  Covidien LP · Devices · 2023-06-28
  Class I
• CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele

  Abbott Medical · Devices · 2023-07-18
  Class I
• Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

  Datascope Corp. · Devices · 2023-07-31
  Class I
• CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ90

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• smiths medical Medfusion Model 3500 Syringe pump

  Smiths Medical ASD Inc. · Devices · 2023-12-19
  Class I
• Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an ele

  Abbott Medical · Devices · 2023-07-18
  Class I
• GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 20828

  DATEX--OHMEDA, INC. · Devices · 2023-06-06
  Class I
• VariSoft infusion set, Model Number 1002828

  Unomedical A/S · Devices · 2023-10-11
  Class I
• Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

  ICU Medical Inc · Devices · 2023-03-22
  Class I
• ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap

  Insulet Corporation · Devices · 2023-11-30
  Class I
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ASM Replacement Battery, Component Number SUB0000864

  ICU Medical Inc · Devices · 2023-03-22
  Class I
• CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,

  ARROW INTERNATIONAL Inc. · Devices · 2023-08-10
  Class I
• Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

  Olympus Corporation of the Americas · Devices · 2023-09-22
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577

  Cook Incorporated · Devices · 2023-04-07
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US)

  Philips Respironics, Inc. · Devices · 2023-08-25
  Class I
• Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Monoject 20 mL Syringe Luer-Lock Tip Soft Pack

  Cardinal Health 200, LLC · Devices · 2023-09-20
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,

  Philips Respironics, Inc. · Devices · 2023-05-01
  Class I
• BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4

  Philips North America · Devices · 2023-12-15
  Class I
• Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator

  Hamilton Medical, Inc. · Devices · 2023-07-26
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200

  Covidien LP · Devices · 2023-06-28
  Class I
• ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Regard Dressing change kit, Item Number 800026006

  ROi CPS LLC · Devices · 2023-11-20
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur

  Asensus Surgical Inc · Devices · 2023-09-15
  Class I
• Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

  Hamilton Medical, Inc. · Devices · 2023-07-26
  Class I
• HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-08-04
  Class I
• Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst

  Philips North America Llc · Devices · 2023-11-17
  Class I
• Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Set2Go Ventilation 12 (A), MP07968

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603

  Covidien LP · Devices · 2023-06-28
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0

  Datascope Corp. · Devices · 2023-06-05
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and opt

  Hamilton Medical, Inc. · Devices · 2023-06-15
  Class I
• MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE134

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

  Percussionaire Corporation · Devices · 2023-12-12
  Class I
• ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Impella LD intravascular micro axial blood pump, Product Number 005082

  Abiomed, Inc. · Devices · 2023-06-14
  Class I
• Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA30

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

  Draeger Medical, Inc. · Devices · 2023-01-23
  Class I
• CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

  Olympus Corporation of the Americas · Devices · 2023-10-12
  Class I
• Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Seattle PAP Plus, MP02260

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP

  Covidien LP · Devices · 2023-06-28
  Class I
• Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

  Windstone Medical Packaging, Inc. · Devices · 2023-12-22
  Class I
• Alaris PCA Module 8120

  CareFusion 303, Inc. · Devices · 2023-09-15
  Class I
• Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3

  B. Braun Medical, Inc. · Devices · 2023-11-01
  Class I
• ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

  B. Braun Medical, Inc. · Devices · 2023-09-21
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Hamilton-MR1, REF: 161010, Intensive Care Ventilator

  Hamilton Medical, Inc. · Devices · 2023-07-26
  Class I
• Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring

  Abbott Diabetes Care, Inc. · Devices · 2023-02-13
  Class I
• 2008T HD SYS. W/O CDX BLUESTAR

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

  Hamilton Medical, Inc. · Devices · 2023-07-26
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• BD Alaris Syringe Module, REF 8110

  CareFusion 303, Inc. · Devices · 2023-09-15
  Class I
• smiths medical Medfusion Model 4000 syringe pump

  Smiths Medical ASD Inc. · Devices · 2023-12-19
  Class I
• Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-

  SD Biosensor, Inc. · Devices · 2023-03-31
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637

  Covidien LP · Devices · 2023-06-28
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

  Datascope Corp. · Devices · 2023-07-31
  Class I
• Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

  Baxter Healthcare Corporation · Devices · 2023-01-25
  Class I
• ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104

  Covidien LP · Devices · 2023-06-28
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)

  Cook Incorporated · Devices · 2023-04-07
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Impella 5.0 intravascular micro axial blood pump, Product Number 005062

  Abiomed, Inc. · Devices · 2023-06-14
  Class I
• ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• 2008T Hemodialysis SYS, with CDX

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• VentStar Anesthesia WT (P)180, MP00374

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• ARROW Endurance Extended Dwell Peripheral Catheter System

  ARROW INTERNATIONAL Inc. · Devices · 2023-05-19
  Class I
• Oxylog 3000 Plus emergency and transport ventilator

  Draeger Medical, Inc. · Devices · 2023-06-12
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

  Hamilton Medical, Inc. · Devices · 2023-07-26
  Class I
• Anesthesia Set Coax 180, MP03384

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s

  Abiomed, Inc. · Devices · 2023-04-17
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003H

  Covidien LP · Devices · 2023-06-28
  Class I
• Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 099

  Datascope Corp. · Devices · 2023-02-07
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Astral 100 and Astral 150 ventilators

  ResMed Ltd. · Devices · 2023-09-13
  Class I
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629

  Covidien LP · Devices · 2023-06-28
  Class I
• ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF

  EITAN MEDICAL LTD · Devices · 2023-09-11
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

  Datascope Corp. · Devices · 2023-06-05
  Class I
• BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM

  Olympus Corporation of the Americas · Devices · 2023-10-12
  Class I
• 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

  B. Braun Medical, Inc. · Devices · 2023-09-21
  Class I
• BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074

  Philips North America · Devices · 2023-12-15
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637

  Covidien LP · Devices · 2023-06-28
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-10-16
  Class I
• Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monito

  Abbott Diabetes Care, Inc. · Devices · 2023-02-13
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 888810300

  Covidien LP · Devices · 2023-06-28
  Class I
• Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• VentStar Watertrap (N) 180, MP00363

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

  Baxter Healthcare Corporation · Devices · 2023-06-15
  Class I
• ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

  Datex-Ohmeda, Inc. · Devices · 2023-12-29
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300

  Covidien LP · Devices · 2023-06-28
  Class I
• 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-08-08
  Class I
• CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• VentStar Watertrap (P) 180, MP00361

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

  Busse Hospital Disposables, Inc. · Devices · 2023-11-30
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

  Cardinal Health 200, LLC · Devices · 2023-09-20
  Class I
• CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• VentStar Anesthesia (N) 180, MP00333

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Ventstar Coax, MP03373

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

  Draeger Medical, Inc. · Devices · 2023-01-23
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-08-08
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104

  Covidien LP · Devices · 2023-06-28
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• AirTouch F20 Full Face Mask and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• ID Circuit Basic (P) 180, MP01340

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator

  Hamilton Medical, Inc. · Devices · 2023-07-26
  Class I
• CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• VentStar Basic (P)250, MP00352

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

  Windstone Medical Packaging, Inc. · Devices · 2023-12-22
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP

  Covidien LP · Devices · 2023-06-28
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

  Datascope Corp. · Devices · 2023-07-31
  Class I
• Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Anesthesia Circuit Kit Coax 3, MP02732

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

  Datascope Corp. · Devices · 2023-07-31
  Class I
• BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292

  Philips North America · Devices · 2023-12-15
  Class I
• Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

  Cardinal Health 200, LLC · Devices · 2023-09-20
  Class I
• Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

  Fresenius Kabi USA, LLC · Devices · 2023-03-10
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 4

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

  Wipro GE Healthcare Private Ltd. · Devices · 2023-12-26
  Class I
• CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• AirTouch N20 Nasal Mask and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod

  Abiomed, Inc. · Devices · 2023-12-27
  Class I
• Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ASM Replacement Battery, Component Number SUB0000594

  ICU Medical Inc · Devices · 2023-03-22
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

  Abiomed, Inc. · Devices · 2023-06-14
  Class I
• Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

  Windstone Medical Packaging, Inc. · Devices · 2023-12-22
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611

  Covidien LP · Devices · 2023-06-28
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Carina Sub-Acute Care Ventilator

  Draeger Medical, Inc. · Devices · 2023-07-12
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILIC

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• AirFit F30 Full Face Mask and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

  Olympus Corporation of the Americas · Devices · 2023-10-12
  Class I
• Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110

  Philips Respironics, Inc. · Devices · 2023-05-01
  Class I
• 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV F

  Nurse Assist, LLC · Devices · 2023-11-06
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H

  Covidien LP · Devices · 2023-06-28
  Class I
• Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• AirFit N10 Nasal Masks and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

  Maquet Cardiovascular, LLC · Devices · 2023-12-13
  Class I
• CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

  Wipro GE Healthcare Private Ltd. · Devices · 2023-12-26
  Class I
• ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U

  Philips Respironics, Inc. · Devices · 2023-02-10
  Class I
• EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model

  Olympus Corporation of the Americas · Devices · 2023-10-12
  Class I
• ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

  Medtronic Navigation, Inc. · Devices · 2023-04-11
  Class I
• Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M

  Megadyne Medical Products, Inc. · Devices · 2023-12-08
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0

  Datascope Corp. · Devices · 2023-06-05
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

  NOXBOX LTD · Devices · 2023-05-03
  Class I
• CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

  Datascope Corp. · Devices · 2023-06-05
  Class I
• CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chi

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Ventstar Coax 180, MP03374

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Anesthesia Circuit Kit Coax 1, MP02730

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack

  Cardinal Health 200, LLC · Devices · 2023-09-20
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NUR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML B

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intra

  ARROW INTERNATIONAL Inc. · Devices · 2023-08-10
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega S

  Megadyne Medical Products, Inc. · Devices · 2023-12-08
  Class I
• Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in no

  BearCare, Inc. · Devices · 2023-05-10
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

  Windstone Medical Packaging, Inc. · Devices · 2023-12-22
  Class I
• EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC

  Olympus Corporation of the Americas · Devices · 2023-10-12
  Class I
• MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• VariSoft infusion set, Model Number 1002827

  Unomedical A/S · Devices · 2023-10-11
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 88

  Covidien LP · Devices · 2023-06-28
  Class I
• StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

  Medtronic Navigation, Inc. · Devices · 2023-04-11
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• AirFit F20 Full Face Mask and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbo

  Maquet Medical Systems USA · Devices · 2023-10-10
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Trilogy Evo Universal Ventilator, Model Number DS2000X11B

  Philips Respironics, Inc. · Devices · 2023-05-01
  Class I
• regard Operative LAP, Item Number 800943001; surgical convenience kit

  ROi CPS LLC · Devices · 2023-12-18
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

  Percussionaire Corporation · Devices · 2023-03-28
  Class I
• CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR

  Philips Respironics, Inc. · Devices · 2023-03-01
  Class I
• CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Novum IQ Syringe infusion system, Product Code 40800BAXUS

  Baxter Healthcare Corporation · Devices · 2023-10-13
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004H

  Covidien LP · Devices · 2023-06-28
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• VentStar Basic (N) 180, MP00353

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-85

  Wipro GE Healthcare Private Ltd. · Devices · 2023-12-26
  Class I
• HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults a

  Hamilton Medical, Inc. · Devices · 2023-06-15
  Class I
• Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

  Philips Respironics, Inc. · Devices · 2023-03-01
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

  Cordis US Corp · Devices · 2023-09-26
  Class I
• CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega S

  Megadyne Medical Products, Inc. · Devices · 2023-12-08
  Class I
• Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

  Maquet Cardiovascular, LLC · Devices · 2023-12-13
  Class I
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-08-08
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 099

  Datascope Corp. · Devices · 2023-07-31
  Class I
• Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals

  Baxter Healthcare Corporation · Devices · 2023-01-25
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner

  Covidien · Devices · 2023-03-24
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• VentStar breathing bag Set (P) 110, MP00384

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382025

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Anesthesia Circuit Kit Coax HEPA, MP17102

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model

  Datex-Ohmeda, Inc. · Devices · 2023-12-29
  Class I
• FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring Sy

  Abbott Diabetes Care, Inc. · Devices · 2023-02-13
  Class I
• Ventstar Coax 230, MP03376

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

  Busse Hospital Disposables, Inc. · Devices · 2023-11-30
  Class I
• TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbe

  Datascope Corp. · Devices · 2023-02-07
  Class I
• ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• 2008T Hemodialysis System w/Bibag

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP,

  QUIDEL CARDIOVASCULAR INC · Devices · 2023-05-25
  Class I
• Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description:

  Abbott Medical · Devices · 2023-07-18
  Class I
• Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

  Cardinal Health 200, LLC · Devices · 2023-09-20
  Class I
• 2008T GEN 2 Bibag without CDX

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

  Datascope Corp. · Devices · 2023-07-31
  Class I
• ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R

  ARROW INTERNATIONAL Inc. · Devices · 2023-08-10
  Class I
• ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

  Globus Medical, Inc. · Devices · 2023-12-07
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATE

  Cardinal Health 200, LLC · Devices · 2023-12-04
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

  Abiomed, Inc. · Devices · 2023-06-29
  Class I
• BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.

  Avanos Medical, Inc. · Devices · 2023-02-03
  Class I
• Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an e

  Abbott Medical · Devices · 2023-07-18
  Class I
• EVair air compressor, model numbers: M1230849 and M1230847

  Datex-Ohmeda, Inc. · Devices · 2023-12-29
  Class I
• 2008T HD SYS. CDX W/BIBAG BLUESTAR

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILL

  Nurse Assist, LLC · Devices · 2023-11-06
  Class I
• CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP

  Integra LifeSciences Corp. · Devices · 2023-10-05
  Class I
• VentStar Bag Set (N) 110, MP00383

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• 2008T Hemodialysis System without CDX

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M116

  Wipro GE Healthcare Private Ltd. · Devices · 2023-12-26
  Class I
• Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

  Datascope Corp. · Devices · 2023-02-07
  Class I
• Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

  Baxter Healthcare Corporation · Devices · 2023-01-25
  Class I
• SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

  Baxter Healthcare Corporation · Devices · 2023-06-15
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 888810300

  Covidien LP · Devices · 2023-06-28
  Class I
• GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

  Wipro GE Healthcare Private Ltd. · Devices · 2023-12-26
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE

  Cordis US Corp · Devices · 2023-03-24
  Class I
• BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

  Avanos Medical, Inc. · Devices · 2023-02-03
  Class I
• Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP

  Covidien LP · Devices · 2023-06-28
  Class I
• Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode

  Megadyne Medical Products, Inc. · Devices · 2023-12-08
  Class I
• Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE

  Cordis US Corp · Devices · 2023-03-24
  Class I
• Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15

  Philips Respironics, Inc. · Devices · 2023-03-01
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 208

  DATEX--OHMEDA, INC. · Devices · 2023-06-06
  Class I
• MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• Impella 2.5 intravascular micro axial blood pump, Product Number 005042

  Abiomed, Inc. · Devices · 2023-06-14
  Class I
• Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID

  Nurse Assist, LLC · Devices · 2023-11-06
  Class I
• CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Impella CP intravascular micro axial blood pump, Product Number 0048-0032

  Abiomed, Inc. · Devices · 2023-06-14
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888

  Covidien LP · Devices · 2023-06-28
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Baxter Exactamix Pro 1200, REF EXM12DY

  Baxter Healthcare Corporation · Devices · 2023-12-22
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE

  Cordis US Corp · Devices · 2023-03-24
  Class I
• StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cra

  Medtronic Navigation, Inc. · Devices · 2023-09-27
  Class I
• Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• AirFit F30i Full Face Mask and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

  Mallinckrodt Manufacturing LLC · Devices · 2023-08-08
  Class I
• Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

  Covidien · Devices · 2023-09-28
  Class I
• Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Baxter Exactamix Pro 2400, REF EXM24DY

  Baxter Healthcare Corporation · Devices · 2023-12-22
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• TruSignal Wrap Sensor, REF TS-W-D; Oximeter

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP

  Covidien LP · Devices · 2023-06-28
  Class I
• Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

  Busse Hospital Disposables, Inc. · Devices · 2023-11-30
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• AirFit N20 Nasal Mask and User Guide

  ResMed Ltd. · Devices · 2023-11-20
  Class I
• CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery

  Megadyne Medical Products, Inc. · Devices · 2023-06-01
  Class I
• CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• VentStar Watertrap (P) 180 w/oLL, MP00362

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-10-16
  Class I
• ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888

  Covidien LP · Devices · 2023-06-28
  Class I
• Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197

  ICU Medical Inc · Devices · 2023-03-22
  Class I
• Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE

  Nurse Assist, LLC · Devices · 2023-11-06
  Class I
• Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

  Abbott · Devices · 2023-06-12
  Class I
• (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-10-16
  Class I
• VentStar Coax (P) 150, MP00379

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• VariSoft infusion set, Model Number 1002830

  Unomedical A/S · Devices · 2023-10-11
  Class I
• Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• ID Coax 180, MP03375

  Draeger Medical, Inc. · Devices · 2023-04-17
  Class I
• Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100

  Abiomed, Inc. · Devices · 2023-06-14
  Class I
• MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, F

  Philips Respironics, Inc. · Devices · 2023-05-01
  Class I
• TruSignal Ear Sensor, REF TS-E-D; Oximeter

  GE Healthcare Finland Oy · Devices · 2023-05-19
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbe

  Datascope Corp. · Devices · 2023-02-07
  Class I
• MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC

  Cordis US Corp · Devices · 2023-03-24
  Class I
• MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class I
• ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is a

  Abbott Medical · Devices · 2023-07-18
  Class I
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

  Datascope Corp. · Devices · 2023-07-31
  Class I
• Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

  Nurse Assist, LLC · Devices · 2023-11-06
  Class I
• Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, RE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T

  Cardinal Health 200, LLC · Devices · 2023-12-28
  Class I
• BD Alaris PCU REF 8015

  CareFusion 303, Inc. · Devices · 2023-09-15
  Class I
• Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals

  Baxter Healthcare Corporation · Devices · 2023-01-25
  Class I
• CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-15
  Class I
• Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic,

  ARROW INTERNATIONAL Inc. · Devices · 2023-08-10
  Class I
• CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators

  Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Devices · 2023-05-10
  Class I
• 2008T HD SYS. CDX BLUESTAR

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-09-06
  Class I
• Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020

  TELEFLEX LLC · Devices · 2023-05-25
  Class I
• Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UN

  Unichem Pharmaceuticals USA Inc. · Drugs · 2026-01-21
  Class II
• HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac

  The Harvard Drug Group LLC · Drugs · 2026-04-09
  Class II
• Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmin

  Spectra Medical Devices, Llc · Drugs · 2026-05-12
  Class II
• Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f

  Apotex Corp. · Drugs · 2026-03-05
  Class II
• Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-03-25
  Class II
• Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea

  Thea Pharma, Inc. · Drugs · 2026-04-23
  Class II
• Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Labora

  Ascend Laboratories, LLC · Drugs · 2026-06-01
  Class II
• HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST D

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tatto

  Pro Numb Tattoo Numbing Spray LLC · Drugs · 2026-02-02
  Class II
• Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporatio

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corpo

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054,

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A,

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N.

  Fagron Compounding Services · Drugs · 2026-03-20
  Class II
• iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc

  Thea Pharma, Inc. · Drugs · 2026-04-23
  Class II
• Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,

  Appco Pharma LLC · Drugs · 2026-03-27
  Class II
• Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Maj

  The Harvard Drug Group LLC · Drugs · 2026-02-17
  Class II
• 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Frese

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only,

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pou

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-05-29
  Class II
• Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx onl

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-03-17
  Class II
• thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road,

  Fresenius Kabi Compounding, LLC · Drugs · 2026-02-05
  Class II
• ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan

  Fresenius Kabi Compounding, LLC · Drugs · 2026-02-05
  Class II
• Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug prod

  Amerisource Health Services LLC · Drugs · 2026-01-14
  Class II
• FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and

  Owen Biosciences Inc. · Drugs · 2026-03-03
  Class II
• MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug M

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 843

  Harbin Jixianglong Biotech Co., Ltd. · Drugs · 2026-02-13
  Class II
• Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceutic

  Rising Pharma Holding, Inc. · Drugs · 2026-03-03
  Class II
• fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag,

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas

  Alcon Research LLC · Drugs · 2026-04-21
  Class II
• First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner R

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DE

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

  Harrow Eye LLC · Drugs · 2026-04-17
  Class II
• Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:

  Safecor Health, LLC · Drugs · 2026-04-30
  Class II
• Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061,

  New Life Pharma LLC · Drugs · 2026-02-26
  Class II
• DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:

  B BRAUN MEDICAL INC · Drugs · 2026-04-02
  Class II
• traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt

  Amneal Pharmaceuticals, LLC · Drugs · 2026-03-19
  Class II
• Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufact

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-03-19
  Class II
• vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 D

  Fresenius Kabi Compounding, LLC · Drugs · 2026-02-05
  Class II
• Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA Wipes

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, M

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fr

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 36

  IntegraDose Compounding Services LLC · Drugs · 2026-05-12
  Class II
• BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl

  CareFusion 213, LLC · Drugs · 2026-04-22
  Class II
• FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Po

  HTO Nevada Inc. dba Kirkman · Drugs · 2026-02-18
  Class II
• Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2026-04-29
  Class II
• Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Pri

  MACLEODS PHARMA USA, INC · Drugs · 2026-02-26
  Class II
• BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL

  CareFusion 213, LLC · Drugs · 2026-04-22
  Class II
• Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,

  Appco Pharma LLC · Drugs · 2026-03-27
  Class II
• Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, M

  Lupin Pharmaceuticals Inc. · Drugs · 2026-04-24
  Class II
• ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beav

  PAYLESS COMPOUNDERS, LLC · Drugs · 2026-03-06
  Class II
• Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical,

  Oasis Medical, Inc. · Drugs · 2026-04-27
  Class II
• Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,

  Cipla USA, Inc. · Drugs · 2026-03-16
  Class II
• Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceutica

  STRIDES PHARMA INC · Drugs · 2026-03-02
  Class II
• Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Ca

  Apotex Corp. · Drugs · 2026-04-08
  Class II
• MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source,

  HTO Nevada Inc. dba Kirkman · Drugs · 2026-02-18
  Class II
• Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx onl

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-03-17
  Class II
• Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASS

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA

  International Medication Systems Ltd. · Drugs · 2026-04-01
  Class II
• Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEAD

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Frese

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu

  Hikma Pharmaceuticals USA INC · Drugs · 2026-04-07
  Class II
• GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Bra

  Owen Biosciences Inc. · Drugs · 2026-03-03
  Class II
• Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-03-25
  Class II
• Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufact

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-03-19
  Class II
• Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,

  Ajanta Pharma Ltd. · Drugs · 2026-04-29
  Class II
• Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,

  Cipla USA, Inc. · Drugs · 2026-03-16
  Class II
• vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan R

  Fresenius Kabi Compounding, LLC · Drugs · 2026-02-05
  Class II
• ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004,

  Leading Pharma, LLC · Drugs · 2026-03-20
  Class II
• Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, N

  New Life Pharma LLC · Drugs · 2026-02-26
  Class II
• Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500

  Granules Pharmaceuticals Inc. · Drugs · 2026-01-26
  Class II
• BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in U

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag,

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N

  Fagron Compounding Services · Drugs · 2026-03-20
  Class II
• 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD B

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:

  B BRAUN MEDICAL INC · Drugs · 2026-04-02
  Class II
• Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough

  GE Healthcare Ireland Limited · Drugs · 2026-03-24
  Class II
• NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LL

  Acella Pharmaceuticals, LLC · Drugs · 2026-04-20
  Class II
• Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories

  JB Chemicals and Pharmaceuticals Ltd · Drugs · 2026-04-23
  Class II
• Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distribute

  Zep Inc · Drugs · 2026-05-22
  Class II
• Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 50

  Nephron SC, LLC · Drugs · 2026-03-17
  Class II
• Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38

  AvKARE · Drugs · 2026-02-13
  Class II
• Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2026-03-09
  Class II
• Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Phar

  Cipla USA, Inc. · Drugs · 2026-03-13
  Class II
• HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Fo

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distribut

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Housto

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-01-27
  Class II
• Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2026-04-29
  Class II
• Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Dro

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Ma

  SCOPE HEALTH · Drugs · 2026-04-20
  Class II
• Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0

  Ajanta Pharma Ltd. · Drugs · 2026-04-29
  Class II
• Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mou

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-03-25
  Class II
• Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx onl

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-03-17
  Class II
• CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A,

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fres

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

  HTO Nevada Inc. dba Kirkman · Drugs · 2026-02-18
  Class II
• QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC

  LEO PHARMA INC · Drugs · 2026-02-10
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-7

  Breckenridge Pharmaceutical, Inc. · Drugs · 2026-06-04
  Class II
• First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufact

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-03-19
  Class II
• acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Ba

  Fresenius Kabi Compounding, LLC · Drugs · 2026-02-05
  Class II
• Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Di

  The Harvard Drug Group LLC · Drugs · 2026-03-24
  Class II
• Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count ba

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Marto

  Breckenridge Pharmaceutical, Inc. · Drugs · 2026-04-21
  Class II
• QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By:

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N.

  Fagron Compounding Services · Drugs · 2026-03-20
  Class II
• Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Co

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 8

  New Life Pharma LLC · Drugs · 2026-02-26
  Class II
• 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("F

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,E

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, N

  New Life Pharma LLC · Drugs · 2026-02-26
  Class II
• Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-04-06
  Class II
• exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by:

  Greenstone Llc · Drugs · 2026-01-15
  Class II
• Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industria

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,ED

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( N

  Amerisource Health Services LLC · Drugs · 2026-03-16
  Class II
• Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-01-29
  Class II
• 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fres

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,

  Appco Pharma LLC · Drugs · 2026-03-27
  Class II
• Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisour

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-05-22
  Class II
• AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

  Encon Safety Products Co · Drugs · 2026-01-06
  Class II
• Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COM

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 402

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals,

  Meitheal Pharmaceuticals, Inc · Drugs · 2026-02-09
  Class II
• Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distribut

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, N

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd

  Ascend Laboratories, LLC · Drugs · 2026-05-05
  Class II
• SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDR

  Owen Biosciences Inc. · Drugs · 2026-03-03
  Class II
• Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactur

  Cipla USA, Inc. · Drugs · 2026-01-02
  Class II
• EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 m

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76

  Asclemed USA Inc. · Drugs · 2026-05-14
  Class II
• Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROU

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fo

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ

  Graviti Pharmaceuticals Private Limited · Drugs · 2026-01-10
  Class II
• caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonko

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra M

  Huons Co., Ltd. · Drugs · 2026-04-02
  Class II
• 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSO

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna,

  UCB Biosciences Inc. · Drugs · 2026-05-08
  Class II
• Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 8438

  Harbin Jixianglong Biotech Co., Ltd. · Drugs · 2026-02-13
  Class II
• FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufac

  SOMERSET THERAPEUTICS LLC · Drugs · 2026-02-04
  Class II
• Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,

  Cipla USA, Inc. · Drugs · 2026-03-16
  Class II
• Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort W

  Alcon Research LLC · Drugs · 2026-04-21
  Class II
• ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC

  Viatris, Inc. · Drugs · 2026-03-17
  Class II
• Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured

  Huons Co., Ltd. · Drugs · 2026-04-02
  Class II
• Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2

  Fresenius Medical Care Holdings, Inc. · Drugs · 2026-04-06
  Class II
• Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, In

  ANI Pharmaceuticals, Inc. · Drugs · 2026-05-12
  Class II
• Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg

  Preferred Pharmaceuticals, Inc. · Drugs · 2026-03-25
  Class II
• Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-04-24
  Class II
• Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524,

  B BRAUN MEDICAL INC · Drugs · 2026-04-02
  Class II
• Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My

  MYLAN PHARMACEUTICALS INC · Drugs · 2026-02-24
  Class II
• Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern

  ENDO USA, Inc. · Drugs · 2026-03-13
  Class II
• MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Lab

  Ascend Laboratories, LLC · Drugs · 2026-04-27
  Class II
• 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-E

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. W

  Fagron Compounding Services · Drugs · 2026-03-20
  Class II
• Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, C

  Huons Co., Ltd. · Drugs · 2026-04-02
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Eur

  Breckenridge Pharmaceutical, Inc. · Drugs · 2026-06-04
  Class II
• STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bot

  K.C. Pharmaceuticals, Inc · Drugs · 2026-03-03
  Class II
• H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE &

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Ph

  Specialty Process Labs LLC · Drugs · 2026-01-16
  Class II
• Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 4932

  Radnostix · Drugs · 2026-01-26
  Class II
• Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LL

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801

  B BRAUN MEDICAL INC · Drugs · 2026-04-02
  Class II
• Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed

  Pro Numb Tattoo Numbing Spray LLC · Drugs · 2026-02-02
  Class II
• 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fres

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 275

  Chiesi USA, Inc. · Drugs · 2026-03-17
  Class II
• fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15

  Wells Pharma of Houston LLC · Drugs · 2026-04-01
  Class II
• Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-01-29
  Class II
• Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By:

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 U

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, N

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-01-29
  Class II
• Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-05-22
  Class II
• 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD B

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc.

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-01-12
  Class II
• Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA,

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wi

  Fagron Compounding Services · Drugs · 2026-03-20
  Class II
• HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEP

  Owen Biosciences Inc. · Drugs · 2026-03-03
  Class II
• GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough

  GE Healthcare Ireland Limited · Drugs · 2026-03-24
  Class II
• WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablet

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-01-29
  Class II
• Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873

  Island Kinetics, Inc. d.b.a. CoValence Laboratories · Drugs · 2026-04-01
  Class II
• Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceu

  Hetero Labs Limited (Unit V) · Drugs · 2026-03-26
  Class II
• MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 7955

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

  Haleon US Holdings LLC · Drugs · 2026-05-11
  Class II
• Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA

  ACME UNITED CORPORATION · Drugs · 2026-01-20
  Class II
• Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 m

  Safecor Health, LLC · Drugs · 2026-05-01
  Class II
• Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Lt

  Huons Co., Ltd. · Drugs · 2026-04-02
  Class II
• QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By:

  Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Drugs · 2026-03-20
  Class II
• GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Ph

  Golden State Medical Supply Inc. · Drugs · 2026-05-29
  Class II
• Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amer

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc.

  Teva Pharmaceuticals USA, Inc · Drugs · 2026-01-12
  Class II
• DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,

  Fresenius Medical Care Holdings, Inc. · Drugs · 2026-04-06
  Class II
• Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philad

  Lannett Company Inc. · Drugs · 2026-05-27
  Class II
• ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.

  F.H. INVESTMENTS, Inc. (dba Asteria Health) · Drugs · 2026-01-26
  Class II
• Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0

  Ajanta Pharma Ltd. · Drugs · 2026-04-29
  Class II
• FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD

  Fresenius Kabi USA, LLC · Drugs · 2026-03-11
  Class II
• Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,

  Cipla USA, Inc. · Drugs · 2026-03-13
  Class II
• KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG

  Guardian Drug Co. Inc. · Drugs · 2026-05-28
  Class II
• THORACIC ROBOTS, DYNJ908777B

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

  INSPIREMD Inc · Devices · 2026-05-01
  Class II
• SIGNA Premier systems

  GE Healthcare LLC · Devices · 2026-02-27
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

  Becton Dickinson & Co. · Devices · 2026-04-07
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25"

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

  XTANT Medical Holdings, Inc · Devices · 2026-02-18
  Class II
• Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

  Orthalign, Inc · Devices · 2026-02-10
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-0027/11;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERN

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version:

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

  Orthalign, Inc · Devices · 2026-02-10
  Class II
• Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/U

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Allia IGS 3 Pulse angiographic X-ray system

  GE Medical Systems, LLC · Devices · 2026-04-20
  Class II
• Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

  Medline Industries, LP · Devices · 2026-01-08
  Class II
• React Health PHOENIX 5L Oxygen Concentrator

  3B Medical, Inc. · Devices · 2026-02-04
  Class II
• Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ90939

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Bicarby Dialysate; Model number: RFP-400-G;

  Fresenius Medical Care Holdings, Inc. · Devices · 2026-05-07
  Class II
• MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Nu

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMI

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

  Olympus Corporation of the Americas · Devices · 2026-03-23
  Class II
• Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM AN

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:

  Hologic, Inc · Devices · 2026-03-23
  Class II
• Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

  ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Devices · 2026-03-10
  Class II
• eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

  Philips North America · Devices · 2026-04-14
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Pr

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

  Medline Industries, LP · Devices · 2026-01-08
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

  Covidien LLC · Devices · 2026-04-23
  Class II
• Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m

  MICROVENTION INC. · Devices · 2026-04-06
  Class II
• LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

  LSL Healthcare Inc. · Devices · 2026-03-09
  Class II
• Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc

  DJO, LLC · Devices · 2026-03-19
  Class II
• Burlington Medical, Wrap Aprons.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF,

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be

  Olympus Corporation of the Americas · Devices · 2026-01-29
  Class II
• GEM Premier 5000 PAK, Part No. 00055360004.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• One Step K in vitro diagnostic test REF: 81A4

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• Yeastone Broth, 11ML, 10/BOX YY3462

  Remel, Inc · Devices · 2026-03-24
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing wit

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-01-16
  Class II
• Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

  Centinel Spine, Inc. · Devices · 2026-03-20
  Class II
• BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to

  Olympus Corporation of the Americas · Devices · 2026-01-29
  Class II
• See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Mod

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Exte

  Mozarc Medical US LLC · Devices · 2026-04-29
  Class II
• Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

  Gentuity, LLC · Devices · 2026-03-23
  Class II
• FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577

  Physio-Control, Inc. · Devices · 2026-04-13
  Class II
• Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGR

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Brilliance iCT; Product Code (REF): 728306;

  Philips North America Llc · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

  Beckman Coulter Mishima K.K. · Devices · 2026-01-30
  Class II
• SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60

  Hologic, Inc · Devices · 2026-04-08
  Class II
• Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DY

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f

  Medtronic, Inc. · Devices · 2026-03-11
  Class II
• Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software V

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe

  Philips North America · Devices · 2026-04-14
  Class II
• Artelon FlexBand Dynamic Matrix Ref: 31057

  International Life Sciences · Devices · 2026-02-06
  Class II
• Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem

  Biomerieux Inc · Devices · 2026-01-05
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Spectral CT; Product Code (REF): 728333;

  Philips North America Llc · Devices · 2026-01-07
  Class II
• Burlington Medical, Leg Wraps.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

  Becton, Dickinson and Company · Devices · 2026-04-08
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medlin

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• GEM Premier 5000; Part No. 00055415005.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-04-28
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catal

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-8030/12;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Pro

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

  LSL Healthcare Inc. · Devices · 2026-03-09
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B;

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Allura Xper FD20/15 OR Table; System Code: 722059;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Sm

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Numb

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• MiniMed 620G Insulin Pump (MMT-1750)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

  Synthes (USA) Products LLC · Devices · 2026-02-25
  Class II
• Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits conta

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular cat

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated;

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System

  Bayer Medical Care, Inc. · Devices · 2026-04-24
  Class II
• Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Softwar

  Spacelabs Healthcare, Inc. · Devices · 2026-03-26
  Class II
• BD Kiestra" ReadA; Catalog No.: 446948.

  BD KIESTRA LAB AUTOMATION · Devices · 2026-02-06
  Class II
• Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (At

  Raz Design Inc · Devices · 2026-01-05
  Class II
• HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• GEM Premier 5000; Model No. 00055430010.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP,

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS98509

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GEM Premier 5000; Part No. 00055430008.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-8521/15;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

  Wilson-Cook Medical Inc. · Devices · 2026-03-03
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

  Olympus Corporation of the Americas · Devices · 2026-03-23
  Class II
• Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

  INSPIREMD Inc · Devices · 2026-05-01
  Class II
• VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

  Milestone S.R.L. · Devices · 2026-03-09
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 AN

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10

  Boston Scientific Neuromodulation Corporation · Devices · 2026-04-29
  Class II
• NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElasti

  In2bones USA, LLC · Devices · 2026-05-11
  Class II
• Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Produc

  Intuitive Surgical, Inc. · Devices · 2026-04-24
  Class II
• BD Pyxis Mini Main REF: 349 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• GEM Premier 5000; Part No. 00055415008.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Uric Acid in vitro diagnostic test REF: 31H0P

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM;

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forea

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Mo

  Encore Medical, LP · Devices · 2026-01-15
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Bloc

  Kico Knee Innovation Company · Devices · 2026-04-23
  Class II
• Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

  Olympus Corporation of the Americas · Devices · 2026-02-12
  Class II
• SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.0

  Micromed S.p.A. · Devices · 2026-05-04
  Class II
• DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

  Boston Scientific Neuromodulation Corporation · Devices · 2026-04-29
  Class II
• Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000

  Auris Health, Inc · Devices · 2026-01-21
  Class II
• Airway Exam Kit, DYKE1796

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• Paradigm Insulin Pump (MMT-712, MMT-715)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medlin

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,

  Cook Incorporated · Devices · 2026-03-05
  Class II
• GEM Premier 5000 PAK; Part No. 00055407511.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following mat

  Magellan Diagnostics, Inc. · Devices · 2026-03-13
  Class II
• Azurion 5 M12; System Code: (1)722227, (2)722231;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2)

  Medline Industries, LP · Devices · 2026-01-30
  Class II
• Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LI

  Medline Industries, LP · Devices · 2026-01-08
  Class II
• Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product De

  B Braun Medical Inc · Devices · 2026-02-02
  Class II
• Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Mode

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

  Oxoid Australia Pty Limited · Devices · 2026-03-03
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Flamingo Funnel Small, Model Number SQ20012-01

  SurgiSmoke Solutions · Devices · 2026-03-16
  Class II
• Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-01-16
  Class II
• eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

  Exactech, Inc. · Devices · 2026-02-03
  Class II
• Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Burlington Medical, Half Aprons.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device

  Medtronic Neuromodulation · Devices · 2026-04-08
  Class II
• Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYK

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG,

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Burlington Medical, Vest

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAP

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

  Staar Surgical AG · Devices · 2026-01-21
  Class II
• Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular cat

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 931

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Devices · 2026-04-30
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

  Windstone Medical Packaging, Inc. · Devices · 2026-03-11
  Class II
• Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System

  Stryker Corporation · Devices · 2026-05-06
  Class II
• Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

  Fresh Roast Systems Inc · Devices · 2026-04-15
  Class II
• Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

  Medtronic Perfusion Systems · Devices · 2026-01-13
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

  Micro-X Ltd. · Devices · 2026-03-27
  Class II
• See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROT

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GEM Premier 5000 PAK; Part No. 00055360011.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

  Centinel Spine, Inc. · Devices · 2026-03-20
  Class II
• Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog N

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• DxC 700 AU, REF: B86444, B86446

  Beckman Coulter Mishima K.K. · Devices · 2026-01-30
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8

  GE Medical Systems, LLC · Devices · 2026-02-03
  Class II
• PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190

  Physio-Control, Inc. · Devices · 2026-01-21
  Class II
• Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version

  Medartis AG · Devices · 2026-01-09
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• Halyard, Towel Six Pack. Kit Code: AMTS70-01.

  AVID Medical, Inc. · Devices · 2026-04-30
  Class II
• On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

  On-X Life Technologies, Inc. · Devices · 2026-02-01
  Class II
• Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catal

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catal

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produ

  The Binding Site Group, Ltd. · Devices · 2026-04-16
  Class II
• COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part

  Cook Incorporated · Devices · 2026-03-05
  Class II
• MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

  Howmedica Osteonics Corp. · Devices · 2026-02-02
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular ca

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel

  Elekta, Inc. · Devices · 2026-02-18
  Class II
• (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit

  Magellan Diagnostics, Inc. · Devices · 2026-03-13
  Class II
• Access Total T4 Calibrator, Catalog No. 33805

  Beckman Coulter, Inc. · Devices · 2026-03-16
  Class II
• Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377.

  Philips North America · Devices · 2026-04-14
  Class II
• Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

  Medline Industries, LP · Devices · 2026-01-05
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to

  Stryker Corporation · Devices · 2026-04-09
  Class II
• Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU

  Laerdal Medical Corporation · Devices · 2026-01-13
  Class II
• Allia IGS Pulse angiographic X-ray system

  GE Medical Systems, LLC · Devices · 2026-04-20
  Class II
• Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

  Olympus Corporation of the Americas · Devices · 2026-02-12
  Class II
• TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 931

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Devices · 2026-04-30
  Class II
• Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/

  Olympus Corporation of the Americas · Devices · 2026-02-27
  Class II
• BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

  BioFire Diagnostics, LLC · Devices · 2026-04-22
  Class II
• Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• iLet Bionic Pancreas, REF: BB1001

  Beta Bionics, Inc. · Devices · 2026-03-12
  Class II
• Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Burlington Medical, Demi Half Aprons.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

  Brahms GmbH · Devices · 2026-03-12
  Class II
• OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• ALLURA Xper FD10F; System Code: 722002;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU C

  Medline Industries, LP · Devices · 2026-01-08
  Class II
• FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

  FUJIFILM Healthcare Americas Corporation · Devices · 2026-01-09
  Class II
• Halyard, Pain Pack. Kit Code: AMPK48-01.

  AVID Medical, Inc. · Devices · 2026-04-30
  Class II
• Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including

  GE Medical Systems, LLC · Devices · 2026-01-30
  Class II
• LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

  Boston Scientific Corporation · Devices · 2026-03-30
  Class II
• Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: D

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2026-03-18
  Class II
• Allia Moveo angiographic X-ray system

  GE Medical Systems, LLC · Devices · 2026-04-20
  Class II
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

  Siemens Healthcare Diagnostics, Inc. · Devices · 2026-02-23
  Class II
• Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryk

  Stryker Sustainability Solutions · Devices · 2026-03-12
  Class II
• Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

  CareFusion 303, Inc. · Devices · 2026-02-11
  Class II
• QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

  Quidel Corporation · Devices · 2026-04-06
  Class II
• Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESS

  Medline Industries, LP · Devices · 2026-01-08
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe

  Dexcom, Inc. · Devices · 2026-04-14
  Class II
• Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, AC

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/U

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tis

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• GEM Premier 5000 PAK; Part No. 00055407508.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

  GE Medical Systems China Co., Ltd. · Devices · 2026-04-21
  Class II
• LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio

  Boston Scientific Corporation · Devices · 2026-03-30
  Class II
• Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL

  Clariance-SAS · Devices · 2026-02-20
  Class II
• Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Softwa

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code:

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52

  HF Acquisition Co LLC · Devices · 2026-04-13
  Class II
• Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44

  Cook Incorporated · Devices · 2026-03-05
  Class II
• ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap

  Erbe Medical, LLC · Devices · 2026-03-31
  Class II
• MOSAIQ Oncology Information System

  Elekta, Inc. · Devices · 2026-05-21
  Class II
• ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

  Siemens Medical Solutions USA, Inc · Devices · 2026-03-10
  Class II
• Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH

  Medline Industries, LP · Devices · 2026-02-13
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Elec

  Boston Scientific Neuromodulation Corporation · Devices · 2026-04-29
  Class II
• Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

  Straumann USA LLC · Devices · 2026-03-27
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• GEM Premier 5000; Part No. 00055445008.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Num

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GEM Premier 5000 PAK; Part No. 00055407510.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI

  Advanced Bionics, LLC · Devices · 2026-04-30
  Class II
• Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Produ

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• Burlington Medical, Kilt Blockers.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are int

  Covidien LLC · Devices · 2026-04-15
  Class II
• CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

  INSPIREMD Inc · Devices · 2026-05-01
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

  Medtronic MiniMed, Inc. · Devices · 2026-01-30
  Class II
• Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-02-11
  Class II
• Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):

  Philips North America · Devices · 2026-04-14
  Class II
• Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

  Medline Industries, LP · Devices · 2026-04-10
  Class II
• Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

  AVID Medical, Inc. · Devices · 2026-01-02
  Class II
• Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-03-19
  Class II
• Allura Xper FD20/10; System Code: 722029;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S

  Dexcom, Inc. · Devices · 2026-04-14
  Class II
• PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-1

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install

  Foundation Medicine, Inc. · Devices · 2026-03-24
  Class II
• Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/C

  Encore Medical, LP · Devices · 2026-01-15
  Class II
• Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Prod

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Burlington Medical, Protective Sleeves.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code:

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Vers

  Aesculap Inc · Devices · 2026-01-15
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

  Orthorebirth Co Ltd · Devices · 2026-03-25
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medli

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• i-STAT G3+ cartridge; List Number: 03P78-26;

  Abbott Point Of Care Inc. · Devices · 2026-04-01
  Class II
• BD Pyxis MedStation ES REF: 323 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Num

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ8034

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Prod

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Brand Name: Leksell Vantage Arc System REF: 1053958

  Elekta, Inc. · Devices · 2026-03-19
  Class II
• Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize

  Tandem Diabetes Care, Inc. · Devices · 2026-01-30
  Class II
• Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The

  Diagnostica Stago, Inc. · Devices · 2026-02-05
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline K

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Desc

  Baxter Healthcare Corporation · Devices · 2026-01-13
  Class II
• Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)2

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

  Medline Industries, LP · Devices · 2026-02-13
  Class II
• Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782

  Philips North America · Devices · 2026-04-14
  Class II
• eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS

  ReCor Medical Inc. · Devices · 2026-01-29
  Class II
• QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• GEM Premier 5000 PAK; Part No. 00055360008.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

  Cook Incorporated · Devices · 2026-03-05
  Class II
• One Step P in vitro diagnostic test REF: 8194

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

  Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Devices · 2026-02-06
  Class II
• CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-03-06
  Class II
• Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

  Siemens Healthcare Diagnostics, Inc. · Devices · 2026-05-07
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version:

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Allia IGS 5 Pulse angiographic X-ray system

  GE Medical Systems, LLC · Devices · 2026-04-20
  Class II
• Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

  Olympus Corporation of the Americas · Devices · 2026-02-12
  Class II
• IQon Spectral CT; Product Code (REF): 728332;

  Philips North America Llc · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following mat

  Magellan Diagnostics, Inc. · Devices · 2026-03-13
  Class II
• Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutmen

  Straumann USA LLC · Devices · 2026-03-27
  Class II
• Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• Swan-Ganz Pacing Catheter, Models: D200F7;

  Becton, Dickinson and Company · Devices · 2026-04-08
  Class II
• Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• GEM Premier 5000; Part No. 00055445004.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

  ConvaTec, Inc · Devices · 2026-02-16
  Class II
• Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

  ConvaTec, Inc · Devices · 2026-02-16
  Class II
• Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

  Ultradent Products, Inc. · Devices · 2026-01-28
  Class II
• See Luer Cap Set, MPC-130, set, administration, intravascular

  Molded Products Inc · Devices · 2026-02-17
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular cat

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max

  Tornier, Inc · Devices · 2026-03-05
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12

  HF Acquisition Co LLC · Devices · 2026-04-13
  Class II
• One Step pH in vitro diagnostic test REF: 31I4P

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• Artegraft Vascular Graft; REF#: AG740;

  LeMaitre Vascular, Inc. · Devices · 2026-02-10
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or

  Cook Incorporated · Devices · 2026-03-05
  Class II
• I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular cat

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Philips Spectral CT on Rails. Model Number: 728334.

  PHILIPS MEDICAL SYSTEMS · Devices · 2026-03-07
  Class II
• Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,

  Medline Industries, LP · Devices · 2026-01-05
  Class II
• BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-K

  Orthorebirth Co Ltd · Devices · 2026-03-25
  Class II
• Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

  Philips North America · Devices · 2026-04-14
  Class II
• Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G;

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464

  Roche Diagnostics Operations, Inc. · Devices · 2026-01-20
  Class II
• MiniMed 530G Insulin Pump (MMT-551, MMT-751)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

  Philips North America · Devices · 2026-04-14
  Class II
• Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

  Windstone Medical Packaging, Inc. · Devices · 2026-03-11
  Class II
• PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

  LSL Healthcare Inc. · Devices · 2026-03-09
  Class II
• ARTIS Pheno VE30A and VE40A, Model 10849000

  Siemens Medical Solutions USA, Inc · Devices · 2026-03-12
  Class II
• ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS i

  Siemens Medical Solutions USA, Inc · Devices · 2026-03-09
  Class II
• GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047;

  GE Healthcare · Devices · 2026-01-16
  Class II
• EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

  Encore Medical, LP · Devices · 2026-01-05
  Class II
• Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821

  Philips North America · Devices · 2026-04-14
  Class II
• COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

  Cook Incorporated · Devices · 2026-03-05
  Class II
• ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;

  Alphatec Spine, Inc. · Devices · 2026-01-02
  Class II
• Cub Pediatric Crib, Model FL19H

  Stryker Medical Division of Stryker Corporation · Devices · 2026-02-18
  Class II
• Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model N

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5

  Advanced Bionics, LLC · Devices · 2026-03-23
  Class II
• Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4

  Intuitive Surgical, Inc. · Devices · 2026-04-02
  Class II
• Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Desc

  DJO, LLC · Devices · 2026-03-19
  Class II
• COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima

  Hologic, Inc. · Devices · 2026-02-18
  Class II
• Burlington Medical, Frontal Aprons

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions an

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-04-28
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Pr

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• CS300 IABP. Software Version CS300 IABP C.01.

  Datascope Corp. · Devices · 2026-01-23
  Class II
• Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Atellica CH Urine Albumin (UAlb). Material Number: 11537225

  Siemens Healthcare Diagnostics, Inc. · Devices · 2026-01-20
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• GEM Premier 5000; Part No. 00055415010.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• CS100 IABP. Software Version CS100 IABP Q.01.

  Datascope Corp. · Devices · 2026-01-23
  Class II
• LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

  LSL Healthcare Inc. · Devices · 2026-03-09
  Class II
• Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu

  GE Medical Systems, LLC · Devices · 2026-01-30
  Class II
• Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

  Olympus Corporation of the Americas · Devices · 2026-02-12
  Class II
• Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105

  Philips North America · Devices · 2026-04-14
  Class II
• Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, M

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEX

  International Life Sciences · Devices · 2026-02-06
  Class II
• MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• PIE PAK Models: P2HC-A, P2HC-S, P2HC

  Edermy LLC · Devices · 2026-01-14
  Class II
• Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

  Straumann USA LLC · Devices · 2026-03-17
  Class II
• Flamingo Funnel Medium, Model Number SQ20012-02

  SurgiSmoke Solutions · Devices · 2026-03-16
  Class II
• ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

  Aniara Diagnostica LLC · Devices · 2026-04-01
  Class II
• MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

  KOB GmbH · Devices · 2026-01-15
  Class II
• Plum Duo Precision IV Pump, 40002-0403

  ICU Medical, Inc. · Devices · 2026-04-29
  Class II
• Diowave Laser System, REF: Diowave 250W

  Technological Medical Advancements LLC · Devices · 2026-01-09
  Class II
• Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Artelon FlexBand Plus Ref: 41054 & 41057

  International Life Sciences · Devices · 2026-02-06
  Class II
• Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

  Davol, Inc. · Devices · 2026-03-25
  Class II
• One Step 10A in vitro diagnostic test

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GEM Premier 5000; Part No. 00055430004.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit numb

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM;

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Num

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

  Reflexion Medical, Inc. · Devices · 2026-02-09
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X

  Novapproach Spine, LLC · Devices · 2026-04-23
  Class II
• HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03

  Covidien LLC · Devices · 2026-01-30
  Class II
• LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

  LSL Healthcare Inc. · Devices · 2026-03-09
  Class II
• Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

  Philips North America · Devices · 2026-04-14
  Class II
• Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Sim

  AMO Puerto Rico Manufacturing, Inc. · Devices · 2026-02-19
  Class II
• TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Pro

  Grace Medical, Inc. · Devices · 2026-04-03
  Class II
• Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341.

  Philips North America · Devices · 2026-04-14
  Class II
• Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand

  C.R. Bard Inc · Devices · 2026-04-23
  Class II
• BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

  Philips North America · Devices · 2026-04-14
  Class II
• Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

  Healthmark Industries Co., Inc. · Devices · 2026-03-12
  Class II
• CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCP

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-0027/15;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Produ

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tu

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• GEM Premier 5000; Part No: 00055415011.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Produc

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Burlington Medical, Blockers.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 008500

  Stryker Corporation · Devices · 2026-01-21
  Class II
• Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descri

  Abbott Diagnostics Scarborough, Inc. · Devices · 2026-02-09
  Class II
• Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

  Merit Medical Systems, Inc. · Devices · 2026-04-02
  Class II
• Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog N

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

  Olympus Corporation of the Americas · Devices · 2026-03-23
  Class II
• Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

  TANGENT ENDOSCOPY, LLC · Devices · 2026-03-23
  Class II
• Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A

  B Braun Medical Inc · Devices · 2026-02-02
  Class II
• Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens

  Immuno-Mycologics, Inc · Devices · 2026-03-26
  Class II
• PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

  Oculus Technologies of Mexico, S.A. de C.V. · Devices · 2026-04-27
  Class II
• Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Refere

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth

  Mentor Texas, LP. · Devices · 2026-02-18
  Class II
• Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLAND

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

  Becton Dickinson & Company · Devices · 2026-01-27
  Class II
• Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-31
  Class II
• Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, M

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkins

  Medtronic Neuromodulation · Devices · 2026-05-13
  Class II
• Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medli

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT,

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Numb

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Halyard, Drape Pack. Kit Code: LMDP36-01.

  AVID Medical, Inc. · Devices · 2026-04-30
  Class II
• i-STAT EG7+ cartridge; List Number: 03P76-25;

  Abbott Point Of Care Inc. · Devices · 2026-04-01
  Class II
• eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

  Siemens Medical Solutions USA, Inc · Devices · 2026-03-09
  Class II
• MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-01-16
  Class II
• Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

  Fresenius Medical Care Holdings, Inc. · Devices · 2026-05-12
  Class II
• Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-04-30
  Class II
• COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

  Fresenius Kabi USA, LLC · Devices · 2026-02-04
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

  Diversatek Healthcare · Devices · 2026-03-18
  Class II
• BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article N

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

  Siemens Healthcare Diagnostics Inc · Devices · 2026-04-02
  Class II
• BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

  Becton Dickinson & Co. · Devices · 2026-04-07
  Class II
• Campy CVA Medium 100/PK, R01272

  Remel, Inc · Devices · 2026-02-05
  Class II
• Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

  Edwards Lifesciences, LLC · Devices · 2026-03-27
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-

  Shimadzu Medical Systems · Devices · 2026-04-20
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

  SSC- Surgical Specialties Corporation · Devices · 2026-04-23
  Class II
• Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version

  B Braun Medical Inc · Devices · 2026-02-02
  Class II
• DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

  DeRoyal Industries Inc · Devices · 2026-05-18
  Class II
• BD Pyxis MedStation 4000 REF: 303 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

  Covidien LLC · Devices · 2026-04-23
  Class II
• Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OE

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.

  Olympus Corporation of the Americas · Devices · 2026-03-23
  Class II
• Allura Xper FD20/20 OR Table; System Code: 722039;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog N

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

  Exactech, Inc. · Devices · 2026-02-03
  Class II
• DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

  Philips North America Llc · Devices · 2026-05-01
  Class II
• Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.),

  O&M HALYARD INC · Devices · 2026-04-13
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH P

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe

  Dexcom, Inc. · Devices · 2026-04-14
  Class II
• Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Pr

  Avanos Medical, Inc. · Devices · 2026-04-30
  Class II
• Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSY

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

  Covidien LLC · Devices · 2026-04-23
  Class II
• Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to

  Boston Scientific Corporation · Devices · 2026-05-12
  Class II
• Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog

  Olympus Corporation of the Americas · Devices · 2026-02-27
  Class II
• Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Softwa

  Baxter Healthcare Corporation · Devices · 2026-02-18
  Class II
• Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular cat

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYN

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• IBA Proton Therapy System - PROTEUS 235

  Ion Beam Applications S.A. · Devices · 2026-02-03
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/S

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

  LSL Healthcare Inc. · Devices · 2026-03-09
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Hintermann Series Talar Implant, Left, Size 2 REF 302112

  DT MedTech, LLC · Devices · 2026-03-24
  Class II
• Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Bloc

  Kico Knee Innovation Company · Devices · 2026-04-23
  Class II
• Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including

  GE Medical Systems, LLC · Devices · 2026-01-30
  Class II
• GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The

  Uvlizer c/o RAIS INTERNATIONAL LLC · Devices · 2026-03-06
  Class II
• Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

  Diversatek Healthcare · Devices · 2026-03-18
  Class II
• Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

  Diversatek Healthcare · Devices · 2026-03-18
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-2835/12;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and correspo

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-02-11
  Class II
• Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Produc

  DJO, LLC · Devices · 2026-03-19
  Class II
• Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-03-19
  Class II
• Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401;

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Flamingo Funnel Large, Model Number SQ20012-03

  SurgiSmoke Solutions · Devices · 2026-03-16
  Class II
• Halyard, Eye Bag Pack. Kit Code: UIEB48-01.

  AVID Medical, Inc. · Devices · 2026-04-30
  Class II
• Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

  Merit Medical Systems, Inc. · Devices · 2026-04-02
  Class II
• One Step UTI in vitro diagnostic test REF: 3374

  DFI Co., Ltd. · Devices · 2026-04-02
  Class II
• Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-04-30
  Class II
• Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Pro

  Diagnostica Stago, Inc. · Devices · 2026-02-04
  Class II
• Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: S

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D

  Hologic, Inc · Devices · 2026-04-08
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Sterile Radiology Procedure Kits, Model Number DYNDH1491B

  Medline Industries, LP · Devices · 2026-02-18
  Class II
• Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T;

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System

  VANTIVE US HEALTHCARE LLC · Devices · 2026-01-06
  Class II
• CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

  INSPIREMD Inc · Devices · 2026-05-01
  Class II
• GEM Premier 5000; Part No. 00055430011.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

  Covidien, LP · Devices · 2026-04-15
  Class II
• Plum Duo Infusion Pump, 40002-0401

  ICU Medical, Inc. · Devices · 2026-04-29
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L

  Medline Industries, LP · Devices · 2026-01-28
  Class II
• Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

  Encore Medical, LP · Devices · 2026-01-15
  Class II
• LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

  Linkbio Corp. · Devices · 2026-03-12
  Class II
• The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission

  Uvlizer c/o RAIS INTERNATIONAL LLC · Devices · 2026-03-06
  Class II
• Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-04-28
  Class II
• eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

  Civco Medical Instruments Co. Inc. · Devices · 2026-03-02
  Class II
• Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions:

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-01-26
  Class II
• Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

  Straumann USA LLC · Devices · 2026-03-17
  Class II
• Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G;

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

  INSPIREMD Inc · Devices · 2026-05-01
  Class II
• Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

  Philips North America · Devices · 2026-04-14
  Class II
• FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line I

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medli

  Medline Industries, LP · Devices · 2026-03-16
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-2836/11;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Ca

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-04-10
  Class II
• Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 107

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit N

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RES

  Medline Industries, LP · Devices · 2026-01-28
  Class II
• Burlington Medical, Thyroid Shield.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• CLARITY II Laser System; Model No. 1110200210.

  Lutronic Corporation · Devices · 2026-01-27
  Class II
• Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Prod

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm

  ConvaTec, Inc · Devices · 2026-02-16
  Class II
• BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Mo

  Jolife AB · Devices · 2026-04-13
  Class II
• Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instr

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Produc

  DJO, LLC · Devices · 2026-03-19
  Class II
• GEM Premier 5000 PAK; Part No. 00055360010.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

  Stryker Communications · Devices · 2026-02-23
  Class II
• AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM;

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-04-28
  Class II
• Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• Burlington Medical, Caps.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TO

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (21

  Medline Industries, LP · Devices · 2026-01-05
  Class II
• Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CD

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

  Merit Medical Systems, Inc. · Devices · 2026-04-02
  Class II
• GEM Premier 5000 PAK; Part No. 00055415004.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 So

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GEM Premier 5000; Part No. 00055445010 & 00055445011.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

  Windstone Medical Packaging, Inc. · Devices · 2026-03-11
  Class II
• Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code

  ARROW INTERNATIONAL, LLC · Devices · 2026-03-11
  Class II
• HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

  Devicor Medical Products Inc · Devices · 2026-04-24
  Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular ca

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• See complete list in RES, exceeds character limit. Medline Surgical Gowns

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM201

  Medline Industries, LP · Devices · 2026-01-05
  Class II
• Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These ins

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral T

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Mo

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version

  Medartis AG · Devices · 2026-01-09
  Class II
• Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

  Inter-Med Llc · Devices · 2026-05-27
  Class II
• Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Allura Xper FD20/15; System Code: 722058;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Plum Solo Precision IV Pump, 40001-0401

  ICU Medical, Inc. · Devices · 2026-04-29
  Class II
• Allura Xper FD20/20; System Code: 722038;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-03-19
  Class II
• TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 931

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Devices · 2026-04-30
  Class II
• Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixati

  Medartis AG · Devices · 2026-04-24
  Class II
• Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock

  ICU Medical, Inc. · Devices · 2026-03-24
  Class II
• Burlington Medical, Kilt

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2026-03-19
  Class II
• ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;

  Alphatec Spine, Inc. · Devices · 2026-01-02
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 0

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE

  Medline Industries, LP · Devices · 2026-01-08
  Class II
• Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 7

  Philips North America · Devices · 2026-04-14
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

  Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Devices · 2026-02-06
  Class II
• BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

  Foundation Medicine, Inc. · Devices · 2026-03-20
  Class II
• Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N

  Cook Incorporated · Devices · 2026-03-05
  Class II
• See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHL

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Numbe

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Pr

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Allia IGS 7 Pulse angiographic X-ray system

  GE Medical Systems, LLC · Devices · 2026-04-20
  Class II
• Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

  Burlington Medical, LLC · Devices · 2026-02-11
  Class II
• ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

  GE Medical Systems, LLC · Devices · 2026-03-26
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• i-STAT EG6+ cartridge; List Number: 03P77-25;

  Abbott Point Of Care Inc. · Devices · 2026-04-01
  Class II
• Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

  Cook Incorporated · Devices · 2026-03-05
  Class II
• Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

  Remel Europe Ltd. · Devices · 2026-03-25
  Class II
• Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E

  Koven Technology, Inc. · Devices · 2026-03-04
  Class II
• Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

  Maquet Cardiopulmonary Gmbh · Devices · 2026-01-09
  Class II
• Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Produ

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Ve

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 7821

  Philips North America · Devices · 2026-04-14
  Class II
• See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Numb

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

  Abbott Medical · Devices · 2026-05-12
  Class II
• ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fuji

  Erbe Medical, LLC · Devices · 2026-03-31
  Class II
• Aligned Medical AMS16835 Fluids Kit RX

  Windstone Medical Packaging, Inc. · Devices · 2026-04-27
  Class II
• Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular c

  Medtronic Perfusion Systems · Devices · 2026-04-21
  Class II
• Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Vue Motion V12. Product Number: 1017979.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-05
  Class II
• Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS

  ReCor Medical Inc. · Devices · 2026-01-29
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-8521/09;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

  Erbe Medical, LLC · Devices · 2026-03-31
  Class II
• MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software

  B Braun Medical Inc · Devices · 2026-01-29
  Class II
• MEDLINE ANTERIOR HIP PACK DYNJ64672B

  Medline Industries, LP · Devices · 2026-02-16
  Class II
• Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA

  Olympus Corporation of the Americas · Devices · 2026-02-25
  Class II
• EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF:

  Encore Medical, LP · Devices · 2026-01-05
  Class II
• GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemet

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-60

  Clinical Innovations, LLC · Devices · 2026-03-09
  Class II
• BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Adva

  XTANT Medical Holdings, Inc · Devices · 2026-03-09
  Class II
• BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040;

  Angiodynamics, Inc. · Devices · 2026-03-03
  Class II
• Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x

  BERLIN HEART GMBH · Devices · 2026-04-24
  Class II
• BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

  CareFusion 303, Inc. · Devices · 2026-04-30
  Class II
• Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-0

  Zimmer, Inc. · Devices · 2026-03-30
  Class II
• EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

  Boston Scientific Corporation · Devices · 2026-02-10
  Class II
• Allura Xper FD10C; System Code: 722001;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: S

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• PIE Trolley System Model: 2005

  Edermy LLC · Devices · 2026-01-14
  Class II
• Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software

  Olympus Corporation of the Americas · Devices · 2026-01-07
  Class II
• GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex

  GE Medical Systems Information Technologies Inc · Devices · 2026-04-24
  Class II
• Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

  Mint Medical GmbH · Devices · 2026-01-07
  Class II
• Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re

  Olympus Corporation of the Americas · Devices · 2026-01-08
  Class II
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.

  Synthes (USA) Products LLC · Devices · 2026-02-25
  Class II
• Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw;

  I.T.S. GmbH · Devices · 2026-01-23
  Class II
• Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

  Medline Industries, LP · Devices · 2026-01-05
  Class II
• Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

  Philips North America · Devices · 2026-04-14
  Class II
• Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: D

  Medline Industries, LP · Devices · 2026-01-07
  Class II
• GEM Premier 5000 PAK; Part No. 00055407504.

  Instrumentation Laboratory · Devices · 2026-01-20
  Class II
• Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782

  Philips North America · Devices · 2026-04-14
  Class II
• Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING

  Medline Industries, LP · Devices · 2026-02-10
  Class II
• Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Ada

  Agiliti Health - Ellis · Devices · 2026-01-21
  Class II
• Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-8521/11;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS,

  Medline Industries, LP · Devices · 2026-03-19
  Class II
• Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model

  Philips North America · Devices · 2026-04-14
  Class II
• Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08

  Diversatek Healthcare · Devices · 2026-03-18
  Class II
• Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 83

  Becton, Dickinson and Company · Devices · 2026-04-08
  Class II
• CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

  INSPIREMD Inc · Devices · 2026-05-01
  Class II
• MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)

  Medtronic MiniMed, Inc. · Devices · 2026-02-13
  Class II
• Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

  BioFire Diagnostics, LLC · Devices · 2026-04-01
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-0027/12;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkins

  Medtronic Neuromodulation · Devices · 2026-05-13
  Class II
• Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

  Spacelabs Healthcare, Inc. · Devices · 2026-02-27
  Class II
• Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

  DEPUY (IRELAND) · Devices · 2026-04-03
  Class II
• Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGI

  Medline Industries, LP · Devices · 2026-02-25
  Class II
• Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ9

  Medline Industries, LP · Devices · 2026-02-27
  Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

  Olympus Corporation of the Americas · Devices · 2026-03-25
  Class II
• Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

  Cardinal Health 200, LLC · Devices · 2026-02-27
  Class II
• Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description:

  Baxter Healthcare Corporation · Devices · 2026-04-22
  Class II
• Endo-Model Replacement Plateau; Item Number: 15-0027/16;

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2026-01-12
  Class II
• Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number

  Philips North America · Devices · 2026-04-14
  Class II
• Spectral CT 7500 on Rails; Product Code (REF): 728334;

  Philips North America Llc · Devices · 2026-01-07
  Class II
• BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Stryker Sustainability Solutions · Devices · 2026-04-10
  Class II
• ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2026-03-03
  Class II
• DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27

  Katalyst Surgical, LLC · Devices · 2026-03-25
  Class II
• Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef

  ProRx LLC · Drugs · 2025-10-15
  Class II
• Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,

  Somerset Therapeutics Private Limited · Drugs · 2025-03-21
  Class II
• Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Dis

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 871

  Fagron Compounding Services · Drugs · 2025-08-29
  Class II
• Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Rat

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in In

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua The

  ASEGUA THERAPEUTICS LLC · Drugs · 2025-03-07
  Class II
• Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colval

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-09-17
  Class II
• edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.

  Private Label Skin Care Inc. · Drugs · 2025-09-12
  Class II
• Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, F

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4P

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Je

  ProRx LLC · Drugs · 2025-10-15
  Class II
• Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Fre

  KABANA SKIN CARE · Drugs · 2025-03-12
  Class II
• BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudh

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SE

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC

  Direct Rx · Drugs · 2025-01-31
  Class II
• Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceu

  Lupin Pharmaceuticals Inc. · Drugs · 2025-07-02
  Class II
• Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limite

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx On

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60

  A-S Medication Solutions LLC · Drugs · 2025-02-25
  Class II
• Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 1942

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-07-07
  Class II
• 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose containe

  B BRAUN MEDICAL INC · Drugs · 2025-08-04
  Class II
• Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3343

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 619

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flav

  Chattem Inc · Drugs · 2025-03-04
  Class II
• Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manuf

  Ascend Laboratories, LLC · Drugs · 2025-09-19
  Class II
• KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o,

  Apipharma · Drugs · 2025-04-09
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ

  RemedyRepack Inc. · Drugs · 2025-01-24
  Class II
• Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceut

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-07-15
  Class II
• Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Ma

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-12-30
  Class II
• Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribut

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-04
  Class II
• Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R

  ACCORD HEALTHCARE, INC. · Drugs · 2025-04-10
  Class II
• Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030

  Siddha Flower Essences, LLC. · Drugs · 2025-04-28
  Class II
• Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Di

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-24
  Class II
• Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P

  Cipla USA, Inc. · Drugs · 2025-10-24
  Class II
• Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceu

  Graviti Pharmaceuticals Private Limited · Drugs · 2025-09-15
  Class II
• CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manuf

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-07-07
  Class II
• Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American

  Amerisource Health Services LLC · Drugs · 2025-08-27
  Class II
• CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc

  Fruit Of The Earth, Inc. · Drugs · 2025-03-11
  Class II
• Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTiend

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LL

  Amerisource Health Services LLC · Drugs · 2025-01-07
  Class II
• Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured f

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-02-28
  Class II
• Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, O

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• LIQUID DAYQUIL 12/8oz

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,

  Lupin Pharmaceuticals Inc. · Drugs · 2025-06-20
  Class II
• Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pitham

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• EXCEDRIN MIGRAINE 2'S- 25 CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb,

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-05-23
  Class II
• fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CA

  QuVa Pharma, Inc. · Drugs · 2025-03-06
  Class II
• Swan, White Clear Alcohol, 50%, 16oz, 12 count

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manu

  Safecor Health, LLC · Drugs · 2025-10-10
  Class II
• Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) su

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made

  KABANA SKIN CARE · Drugs · 2025-03-12
  Class II
• N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Engl

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), an

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, E

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2025-03-31
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentat

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-38

  Torrent Pharma Inc. · Drugs · 2025-05-27
  Class II
• Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed

  Amerisource Health Services LLC · Drugs · 2025-05-15
  Class II
• Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., P

  Lannett Company Inc. · Drugs · 2025-10-10
  Class II
• Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pith

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufacture

  Apotex Corp. · Drugs · 2025-09-05
  Class II
• Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 1

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Ph

  Direct Rx · Drugs · 2025-03-07
  Class II
• Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx o

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, M

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-02-28
  Class II
• Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy

  Boothwyn Pharmacy LLC · Drugs · 2025-07-09
  Class II
• ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210

  Private Label Skin Care Inc. · Drugs · 2025-09-12
  Class II
• Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limi

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outs

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmac

  The Harvard Drug Group LLC · Drugs · 2025-10-10
  Class II
• Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use O

  Amgen, Inc. · Drugs · 2025-02-27
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd.,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-04-03
  Class II
• Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265

  MYLAN PHARMACEUTICALS INC · Drugs · 2025-02-25
  Class II
• Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel,

  Pharmadel, LLC · Drugs · 2025-04-15
  Class II
• Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per

  World Perfumes Inc. · Drugs · 2025-02-13
  Class II
• Aleve 1's, 60 CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada

  Apotex Corp. · Drugs · 2025-05-28
  Class II
• Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx O

  Cardinal Health Inc. · Drugs · 2025-04-09
  Class II
• Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x2

  AvKARE · Drugs · 2025-09-02
  Class II
• Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx O

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation cani

  AsttraZeneca Pharmaceuticals LP · Drugs · 2025-05-14
  Class II
• Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manuf

  Sandoz Inc · Drugs · 2025-08-13
  Class II
• Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme L

  Merck Sharp & Dohme LLC · Drugs · 2025-12-12
  Class II
• Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 pref

  Cardinal Health Inc. · Drugs · 2025-08-05
  Class II
• Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LL

  FDC Limited · Drugs · 2025-03-11
  Class II
• [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INC

  Consumer Product Partners, LLC · Drugs · 2025-03-07
  Class II
• Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bard

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-08-07
  Class II
• Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronze

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, M

  Park Avenue Compounding · Drugs · 2025-09-17
  Class II
• Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydu

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-03-21
  Class II
• Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product cont

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-01-21
  Class II
• Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-10-07
  Class II
• Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-1

  Golden State Medical Supply Inc. · Drugs · 2025-11-26
  Class II
• Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Ster

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Ca

  Pharmadel, LLC · Drugs · 2025-04-15
  Class II
• Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrige

  Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles · Drugs · 2025-12-27
  Class II
• Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactur

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-22
  Class II
• Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157

  RemedyRePack Inc. · Drugs · 2025-04-22
  Class II
• Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured

  Eugia US LLC · Drugs · 2025-04-21
  Class II
• Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA B

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover fo

  Aspen Biopharma Labs Pvt., Ltd. · Drugs · 2025-02-07
  Class II
• Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-669

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceutic

  SUN PHARMA /TARO · Drugs · 2025-12-09
  Class II
• Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff

  ProRx LLC · Drugs · 2025-10-15
  Class II
• Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham,

  Padagis US LLC · Drugs · 2025-02-06
  Class II
• Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-05-30
  Class II
• Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in Ind

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-22
  Class II
• 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou

  Exela Pharma Sciences LLC · Drugs · 2025-03-07
  Class II
• Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufac

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and

  Aspen Biopharma Labs Pvt., Ltd. · Drugs · 2025-02-07
  Class II
• Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorte

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection,

  Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles · Drugs · 2025-07-01
  Class II
• Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma

  Rising Pharma Holding, Inc. · Drugs · 2025-10-07
  Class II
• Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India,

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-10-07
  Class II
• Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-669

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,

  Ascend Laboratories, LLC · Drugs · 2025-07-09
  Class II
• Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made i

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, I

  VIONA PHARMACEUTICALS INC · Drugs · 2025-10-06
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-11-24
  Class II
• Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, ND

  SpecGx, LLC · Drugs · 2025-12-16
  Class II
• Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single U

  Turbare Manufacturing · Drugs · 2025-02-18
  Class II
• KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, R

  Tailstorm Health INC · Drugs · 2025-06-02
  Class II
• Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Man

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-05-13
  Class II
• Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe,

  Breckenridge Pharmaceutical, Inc · Drugs · 2025-04-14
  Class II
• Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pul

  AvKARE · Drugs · 2025-05-09
  Class II
• Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• MOTRIN 2'S DISP.- 50CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-01-30
  Class II
• Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics

  Amerisource Health Services LLC · Drugs · 2025-04-02
  Class II
• Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distri

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51

  Breckenridge Pharmaceutical, Inc · Drugs · 2025-04-14
  Class II
• PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West S

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC,

  Eugia US LLC · Drugs · 2025-04-10
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-07-25
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC.

  Imprimis NJOF, LLC · Drugs · 2025-12-18
  Class II
• Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Ph

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-05-15
  Class II
• Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Privat

  Heritage Pharmaceuticals Inc · Drugs · 2025-10-06
  Class II
• Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave,

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories

  Ascend Laboratories, LLC · Drugs · 2025-05-23
  Class II
• DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceut

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-02-28
  Class II
• Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-08-06
  Class II
• Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Phila

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-08-05
  Class II
• LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Ba

  Novo Nordisk Inc. · Drugs · 2025-12-19
  Class II
• Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• EXCEDRIN 2'S DISP.- 30 CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablet

  Mylan Institutional, Inc. · Drugs · 2025-03-07
  Class II
• Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 2

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-01-13
  Class II
• chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare

  AvKARE · Drugs · 2025-08-25
  Class II
• PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactu

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block

  Tailstorm Health INC · Drugs · 2025-06-02
  Class II
• Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c).

  Ascend Laboratories, LLC · Drugs · 2025-09-19
  Class II
• Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 2

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeb

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pi

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,

  Fresenius Medical Care Holdings, Inc. · Drugs · 2025-05-27
  Class II
• Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Je

  ProRx LLC · Drugs · 2025-10-15
  Class II
• Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx o

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-10-13
  Class II
• Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou ko

  ibspot · Drugs · 2025-10-09
  Class II
• Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drop

  BRS Analytical Services, LLC · Drugs · 2025-04-23
  Class II
• Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mf

  Safecor Health, LLC · Drugs · 2025-02-17
  Class II
• HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for

  Samsung Bioepis Co., Ltd. · Drugs · 2025-10-10
  Class II
• Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICA

  USV Private Limited · Drugs · 2025-10-09
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Pac

  Amerisource Health Services LLC · Drugs · 2025-08-27
  Class II
• Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 088

  BIOCON PHARMA INC · Drugs · 2025-03-17
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura

  FDC Limited · Drugs · 2025-04-18
  Class II
• L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc.,

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2025-04-21
  Class II
• Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Dist

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-12
  Class II
• fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services

  Fagron Compounding Services · Drugs · 2025-01-31
  Class II
• Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEA

  Denison Pharmaceuticals, LLC · Drugs · 2025-02-24
  Class II
• Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA,

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-02-28
  Class II
• BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pv

  Amneal Pharmaceuticals, LLC · Drugs · 2025-08-18
  Class II
• Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pack

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem

  B BRAUN MEDICAL INC · Drugs · 2025-08-26
  Class II
• TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R

  BSO LLC · Drugs · 2025-04-28
  Class II
• Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Bo

  Chattem Inc · Drugs · 2025-03-26
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P

  Amneal Pharmaceuticals, LLC · Drugs · 2025-08-18
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pv

  Amneal Pharmaceuticals, LLC · Drugs · 2025-08-18
  Class II
• Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffe

  ProRx LLC · Drugs · 2025-10-15
  Class II
• Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 4321

  Slate Run Pharmaceuticals · Drugs · 2025-03-07
  Class II
• Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2m

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Dist

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-12
  Class II
• Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Ther

  Somerset Therapeutics Private Limited · Drugs · 2025-03-21
  Class II
• Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., B

  Alembic Pharmaceuticals Limited · Drugs · 2025-05-07
  Class II
• niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc

  American Regent, Inc. · Drugs · 2025-04-18
  Class II
• Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Far

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Privat

  Heritage Pharmaceuticals Inc · Drugs · 2025-10-06
  Class II
• Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Do

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by

  Cipla USA, Inc. · Drugs · 2025-06-30
  Class II
• Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Dieg

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industrie

  Consumer Product Partners, LLC · Drugs · 2025-05-23
  Class II
• STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

  B BRAUN MEDICAL INC · Drugs · 2025-08-26
  Class II
• Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container,

  B BRAUN MEDICAL INC · Drugs · 2025-08-04
  Class II
• Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distr

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-12
  Class II
• Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) dru

  Medisca Inc. · Drugs · 2025-03-31
  Class II
• Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Dist

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-24
  Class II
• Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-08-06
  Class II
• Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Dist

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-12-30
  Class II
• Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenu

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alphar

  Acella Pharmaceuticals, LLC · Drugs · 2025-09-29
  Class II
• Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6

  Baxter Healthcare Corporation · Drugs · 2025-12-22
  Class II
• Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,

  Apotex Corp. · Drugs · 2025-05-28
  Class II
• Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio

  Amerisource Health Services LLC · Drugs · 2025-10-09
  Class II
• Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferre

  Preferred Pharmaceuticals, Inc. · Drugs · 2025-11-17
  Class II
• KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only

  Tailstorm Health INC · Drugs · 2025-06-02
  Class II
• Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Li

  Dr. Reddy's Laboratories, Inc. · Drugs · 2025-06-30
  Class II
• TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil

  Kenvue Brands LLC · Drugs · 2025-10-21
  Class II
• Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-66

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJO

  The Harvard Drug Group LLC · Drugs · 2025-06-19
  Class II
• Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics

  Amerisource Health Services LLC · Drugs · 2025-04-02
  Class II
• Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, N

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-01-10
  Class II
• Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in

  Eugia US LLC · Drugs · 2025-04-21
  Class II
• La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication

  L'Oreal USA · Drugs · 2025-03-05
  Class II
• Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersbur

  Acuity Specialty Products, Inc. · Drugs · 2025-09-29
  Class II
• darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-11-24
  Class II
• Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville,

  A.P. Deauville, LLC · Drugs · 2025-07-10
  Class II
• Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880

  Novo Nordisk Inc. · Drugs · 2025-12-19
  Class II
• Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT.

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ

  Johnson, S C and Son, Inc · Drugs · 2025-02-13
  Class II
• Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per bo

  Nubratori, Inc · Drugs · 2025-04-15
  Class II
• Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. M

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-06-30
  Class II
• Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Ma

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran

  FDC Limited · Drugs · 2025-07-05
  Class II
• Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soot

  BRS Analytical Services, LLC · Drugs · 2025-04-23
  Class II
• Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories

  Ascend Laboratories, LLC · Drugs · 2025-07-21
  Class II
• Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packagin

  Amerisource Health Services LLC · Drugs · 2025-10-16
  Class II
• RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142

  Cardinal Health Inc. · Drugs · 2025-07-30
  Class II
• Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N

  Amneal Pharmaceuticals, LLC · Drugs · 2025-08-18
  Class II
• Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b)

  Alchemee, LLC · Drugs · 2025-03-12
  Class II
• ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

  Signature Formulations, LLC · Drugs · 2025-12-08
  Class II
• Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Bru

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-06-16
  Class II
• Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in I

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKar

  AvKARE · Drugs · 2025-08-25
  Class II
• NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceu

  Golden State Medical Supply Inc. · Drugs · 2025-10-20
  Class II
• EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American

  Amerisource Health Services LLC · Drugs · 2025-08-27
  Class II
• Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffe

  ProRx LLC · Drugs · 2025-10-15
  Class II
• Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limite

  Amerisource Health Services LLC · Drugs · 2025-04-02
  Class II
• Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Cast

  Pharmadel, LLC · Drugs · 2025-04-15
  Class II
• Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pan

  Alembic Pharmaceuticals Limited · Drugs · 2025-07-25
  Class II
• Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distrib

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-12
  Class II
• CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstems

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL A

  CareFusion 213, LLC · Drugs · 2025-12-17
  Class II
• Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Rato

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 600

  PFIZER INC · Drugs · 2025-08-04
  Class II
• La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cl

  L'Oreal USA · Drugs · 2025-03-05
  Class II
• Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceutica

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 I

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 Wes

  Imprimis NJOF, LLC · Drugs · 2025-07-09
  Class II
• Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC,

  Somerset Therapeutics Private Limited · Drugs · 2025-03-21
  Class II
• Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC

  Pharmadel, LLC · Drugs · 2025-04-15
  Class II
• CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manuf

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-02-17
  Class II
• Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, F

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) p

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRI

  McKesson · Drugs · 2025-01-17
  Class II
• mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210

  Private Label Skin Care Inc. · Drugs · 2025-09-12
  Class II
• Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff

  ProRx LLC · Drugs · 2025-10-15
  Class II
• ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 2

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-07-07
  Class II
• Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distribute

  Ascend Laboratories, LLC · Drugs · 2025-08-28
  Class II
• Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 0158

  Atlantic Management Resources Ltd. · Drugs · 2025-08-27
  Class II
• clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida

  Lupin Pharmaceuticals Inc. · Drugs · 2025-06-27
  Class II
• DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-1

  Pharmadel, LLC · Drugs · 2025-04-15
  Class II
• Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per c

  Medline Industries, LP · Drugs · 2025-09-29
  Class II
• Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg b

  Safecor Health, LLC · Drugs · 2025-02-17
  Class II
• 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798

  Otsuka ICU Medical LLC · Drugs · 2025-10-27
  Class II
• Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by:

  Safecor Health, LLC · Drugs · 2025-02-17
  Class II
• Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL,

  GRACE & FIRE PTY LTD · Drugs · 2025-08-22
  Class II
• Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 1894

  KVK Tech, Inc. · Drugs · 2025-05-09
  Class II
• San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Berg

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscula

  Advanced Pharmaceutical Technology, Inc. · Drugs · 2025-05-30
  Class II
• Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,

  Aurobindo Pharma USA Inc · Drugs · 2025-05-22
  Class II
• Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limite

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-08-08
  Class II
• Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Man

  Lupin Pharmaceuticals Inc. · Drugs · 2025-11-13
  Class II
• Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-

  Nostrum Laboratories, Inc. · Drugs · 2025-07-11
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt

  Amneal Pharmaceuticals, LLC · Drugs · 2025-08-18
  Class II
• Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corpo

  Baxter Healthcare Corporation · Drugs · 2025-08-20
  Class II
• Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-08-07
  Class II
• Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc.

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wi

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 801

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton conta

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,

  Lupin Pharmaceuticals Inc. · Drugs · 2025-11-05
  Class II
• Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-02-28
  Class II
• Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa

  Amerisource Health Services LLC · Drugs · 2025-10-16
  Class II
• Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., N

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-02-06
  Class II
• B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, O

  Apotex Corp. · Drugs · 2025-09-05
  Class II
• Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Far

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-669

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe,

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2025-03-31
  Class II
• Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Alprostadil Container Description: Amber color bottle

  Aspen Biopharma Labs Pvt., Ltd. · Drugs · 2025-02-07
  Class II
• BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vi

  Tailstorm Health INC · Drugs · 2025-06-02
  Class II
• ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carto

  Wuxi Medical lnstrument Factory Co., Ltd. · Drugs · 2025-02-12
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-02-28
  Class II
• fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FS

  QuVa Pharma, Inc. · Drugs · 2025-03-06
  Class II
• CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood,

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Ra

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe

  Cipla USA, Inc. · Drugs · 2025-11-14
  Class II
• Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal

  AvKARE · Drugs · 2025-02-04
  Class II
• Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed b

  Pfizer Inc. · Drugs · 2025-07-10
  Class II
• Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Colu

  Nephron Sterile Compounding Center LLC · Drugs · 2025-02-10
  Class II
• Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe

  Cipla USA, Inc. · Drugs · 2025-11-14
  Class II
• Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-01-21
  Class II
• Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB

  ASTRAZENECA PHARMACEUTICALS · Drugs · 2025-10-08
  Class II
• Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for

  KABANA SKIN CARE · Drugs · 2025-03-12
  Class II
• LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Ner

  Tailstorm Health INC · Drugs · 2025-06-02
  Class II
• Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Out

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India fo

  Eugia US LLC · Drugs · 2025-05-29
  Class II
• Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Div

  Alembic Pharmaceuticals Limited · Drugs · 2025-05-09
  Class II
• Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-cou

  Granules Pharmaceuticals Inc. · Drugs · 2025-06-24
  Class II
• Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB

  Aero Healthcare · Drugs · 2025-10-17
  Class II
• Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM,

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per

  Amerisource Health Services LLC · Drugs · 2025-03-24
  Class II
• PEPTO BISMOL 32CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Man

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-05-13
  Class II
• Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manuf

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-02-17
  Class II
• Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Priv

  Heritage Pharmaceuticals Inc · Drugs · 2025-10-06
  Class II
• Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a c

  Fruit Of The Earth, Inc. · Drugs · 2025-03-11
  Class II
• Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Phar

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, N

  Pfizer · Drugs · 2025-07-29
  Class II
• Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets,

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed i

  Aspen Biopharma Labs Pvt., Ltd. · Drugs · 2025-02-07
  Class II
• Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119,

  SpecGx, LLC · Drugs · 2025-12-16
  Class II
• 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Bra

  B. Braun Medical Inc · Drugs · 2025-03-31
  Class II
• Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra

  ACCORD HEALTHCARE, INC. · Drugs · 2025-04-10
  Class II
• Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy

  Boothwyn Pharmacy LLC · Drugs · 2025-07-09
  Class II
• Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Dist

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-12
  Class II
• Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So

  Somerset Therapeutics Private Limited · Drugs · 2025-03-21
  Class II
• Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manuf

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-07-07
  Class II
• GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office

  BSO LLC · Drugs · 2025-04-28
  Class II
• Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 Universi

  Private Label Skin Care Inc. · Drugs · 2025-09-12
  Class II
• Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 6004

  PFIZER INC · Drugs · 2025-08-04
  Class II
• Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Phar

  The Harvard Drug Group LLC · Drugs · 2025-10-10
  Class II
• Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufacture

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-08-27
  Class II
• clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.

  Lupin Pharmaceuticals Inc. · Drugs · 2025-04-10
  Class II
• Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication

  L'Oreal USA · Drugs · 2025-03-05
  Class II
• ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

  Signature Formulations, LLC · Drugs · 2025-12-08
  Class II
• Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufacture

  Merck Sharp & Dohme LLC · Drugs · 2025-12-12
  Class II
• Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, M

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2025-04-25
  Class II
• Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. B

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-09-03
  Class II
• Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• NYQUIL COLD & FLU -32CT/2PK

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2025-04-21
  Class II
• Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 W

  ACME UNITED CORPORATION · Drugs · 2025-09-23
  Class II
• Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/

  Cipla Limited · Drugs · 2025-10-31
  Class II
• Claritin, 20 Count, UPC: 655708016305

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured

  Sato Pharmaceutical Co., Ltd · Drugs · 2025-12-19
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Dev

  Acuity Specialty Products, Inc. · Drugs · 2025-09-29
  Class II
• DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, F

  Pfizer Inc. · Drugs · 2025-05-28
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutica

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-03-26
  Class II
• Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, ND

  GRACE & FIRE PTY LTD · Drugs · 2025-08-22
  Class II
• Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Mem

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pitha

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721

  Torrent Pharma Inc. · Drugs · 2025-05-27
  Class II
• FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural

  Apollo Care, LLC · Drugs · 2025-04-15
  Class II
• Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P

  Cipla USA, Inc. · Drugs · 2025-10-24
  Class II
• Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa

  Amerisource Health Services LLC · Drugs · 2025-10-16
  Class II
• Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, S

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual

  Amerisource Health Services LLC · Drugs · 2025-08-27
  Class II
• Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapar

  Westminster Pharmaceuticals LLC · Drugs · 2025-08-06
  Class II
• Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe

  Cipla USA, Inc. · Drugs · 2025-11-14
  Class II
• Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1

  A.P. Deauville, LLC · Drugs · 2025-07-10
  Class II
• Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly

  Private Label Skin Care Inc. · Drugs · 2025-09-12
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical T

  Advanced Pharmaceutical Technology, Inc. · Drugs · 2025-10-03
  Class II
• Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-66

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Privat

  Heritage Pharmaceuticals Inc · Drugs · 2025-10-06
  Class II
• Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadel

  Lannett Company Inc. · Drugs · 2025-08-11
  Class II
• Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Phar

  Empower Clinic Services, LLC dba Empower Pharmacy · Drugs · 2025-05-02
  Class II
• Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 3847

  AvKARE · Drugs · 2025-05-13
  Class II
• Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Bruns

  Strides Pharma, Inc. · Drugs · 2025-03-05
  Class II
• Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bot

  BRS Analytical Services, LLC · Drugs · 2025-04-23
  Class II
• Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah,

  Alvogen, Inc · Drugs · 2025-12-31
  Class II
• Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara

  Westminster Pharmaceuticals LLC · Drugs · 2025-08-06
  Class II
• LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dex

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, D

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pi

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India,

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Ave

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R

  BSO LLC · Drugs · 2025-04-28
  Class II
• Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manu

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous o

  Amgen, Inc. · Drugs · 2025-02-27
  Class II
• Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Priva

  Heritage Pharmaceuticals Inc · Drugs · 2025-10-06
  Class II
• niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc

  American Regent, Inc. · Drugs · 2025-04-18
  Class II
• Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKei

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• Bayer 2Pk- 25 CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• PEPCID COMPLETE - 25CT

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-02-28
  Class II
• Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3343

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Bo

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ

  Church & Dwight Co., Inc. · Drugs · 2025-10-01
  Class II
• Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in In

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski,

  AvKARE · Drugs · 2025-12-31
  Class II
• Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only

  Aspiro Pharma Limited · Drugs · 2025-10-01
  Class II
• DAYQUIL COLD & FLU, 32CT/2PK

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC

  Preferred Pharmaceuticals, Inc. · Drugs · 2025-04-18
  Class II
• HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengalur

  SKY PACKAGING · Drugs · 2025-01-24
  Class II
• L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton conta

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio

  Amerisource Health Services LLC · Drugs · 2025-07-29
  Class II
• Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2025-03-31
  Class II
• Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distrib

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-04
  Class II
• R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Vo

  QuVa Pharma, Inc. · Drugs · 2025-10-10
  Class II
• Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 U

  Agebox · Drugs · 2025-10-28
  Class II
• 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx O

  Exela Pharma Sciences LLC · Drugs · 2025-07-30
  Class II
• Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories

  Ascend Laboratories, LLC · Drugs · 2025-05-23
  Class II
• Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, N

  Hikma Pharmaceuticals USA Inc. · Drugs · 2025-07-22
  Class II
• Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Sing

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-02-13
  Class II
• Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 U

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed b

  Pfizer Inc. · Drugs · 2025-07-10
  Class II
• Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662

  Park Avenue Compounding · Drugs · 2025-09-23
  Class II
• Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-

  Ascend Laboratories, LLC · Drugs · 2025-09-19
  Class II
• LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2025-03-31
  Class II
• Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Re

  RC Outsourcing, LLC · Drugs · 2025-09-22
  Class II
• Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima

  Apipharma · Drugs · 2025-04-09
  Class II
• Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactur

  Sandoz Inc · Drugs · 2025-09-05
  Class II
• RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-07-07
  Class II
• Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe

  Fagron Compounding Services · Drugs · 2025-11-20
  Class II
• Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Or

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2025-07-07
  Class II
• Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Heal

  Amerisource Health Services LLC · Drugs · 2025-09-15
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-08-08
  Class II
• LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & E

  Tailstorm Health INC · Drugs · 2025-06-02
  Class II
• Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), a

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safeco

  Safecor Health, LLC · Drugs · 2025-02-17
  Class II
• Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 2

  Sigan Industries Group Inc. · Drugs · 2025-02-28
  Class II
• Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

  Cardinal Health Inc. · Drugs · 2025-07-30
  Class II
• Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2025-04-21
  Class II
• Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 334

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in In

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c

  Ascend Laboratories, LLC · Drugs · 2025-09-19
  Class II
• Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

  Aspen Biopharma Labs Pvt., Ltd. · Drugs · 2025-02-07
  Class II
• babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 8100

  Johnson, S C and Son, Inc · Drugs · 2025-01-08
  Class II
• Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Col

  Safecor Health, LLC · Drugs · 2025-02-17
  Class II
• Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra

  ACCORD HEALTHCARE, INC. · Drugs · 2025-04-10
  Class II
• Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant

  BRS Analytical Services, LLC · Drugs · 2025-04-23
  Class II
• ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Dist

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-04-14
  Class II
• Benadryl, 25'S 2PK Box, UPC 815556020316

  GOLD STAR DISTRIBUTION INC · Drugs · 2025-12-26
  Class II
• Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Ma

  KVK Tech, Inc. · Drugs · 2025-05-09
  Class II
• Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

  Apotex Corp. · Drugs · 2025-05-28
  Class II
• TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not

  BSO LLC · Drugs · 2025-04-28
  Class II
• Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Ey

  BRS Analytical Services, LLC · Drugs · 2025-04-23
  Class II
• Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex In

  Apotex Corp. · Drugs · 2025-05-28
  Class II
• CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. N

  AvKARE · Drugs · 2025-01-21
  Class II
• Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,

  Somerset Therapeutics Private Limited · Drugs · 2025-03-21
  Class II
• Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets

  Mylan Institutional, Inc. · Drugs · 2025-03-07
  Class II
• Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-10-07
  Class II
• Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 4321

  Slate Run Pharmaceuticals · Drugs · 2025-03-07
  Class II
• Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-01-21
  Class II
• Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 334

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF,

  Imprimis NJOF, LLC · Drugs · 2025-12-18
  Class II
• Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., A

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-10-23
  Class II
• Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA,

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Sui

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, C

  Alchemee, LLC · Drugs · 2025-03-12
  Class II
• Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceu

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distr

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only,

  Bristol-Myers Squibb Company · Drugs · 2025-10-21
  Class II
• Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-08-07
  Class II
• Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g)

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-3

  Golden State Medical Supply Inc. · Drugs · 2025-03-05
  Class II
• Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com

  Private Label Skin Care Inc. · Drugs · 2025-09-12
  Class II
• Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Sin

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare

  ACCORD HEALTHCARE, INC. · Drugs · 2025-09-16
  Class II
• KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distribu

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 519

  Breckenridge Pharmaceutical, Inc. · Drugs · 2025-10-09
  Class II
• Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Int

  Dr. Reddy's Laboratories, Inc. · Drugs · 2025-09-26
  Class II
• Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Mad

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifescienc

  VIONA PHARMACEUTICALS INC · Drugs · 2025-08-12
  Class II
• Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx

  Merck & Co. Inc · Drugs · 2025-07-21
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceut

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-11
  Class II
• Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blister

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-09-03
  Class II
• BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray b

  Johnson, S C and Son, Inc · Drugs · 2025-02-13
  Class II
• Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottle

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-10-22
  Class II
• PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Healt

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2025-03-31
  Class II
• Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond,

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-02
  Class II
• Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceutica

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-08-20
  Class II
• Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-09-03
  Class II
• Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containin

  Novocol Pharmaceutical of Canada, Inc. · Drugs · 2025-10-31
  Class II
• Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for:

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2025-04-25
  Class II
• B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R

  ACCORD HEALTHCARE, INC. · Drugs · 2025-04-10
  Class II
• Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by

  IMMUNOCORE, LLC · Drugs · 2025-06-10
  Class II
• Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD

  Medical Products Laboratories, Inc. · Drugs · 2025-11-12
  Class II
• Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave S

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per ca

  Taizhou Kangping Medical Science And Technology Co., Ltd. · Drugs · 2025-07-22
  Class II
• Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su

  Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Drugs · 2025-05-21
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle

  Rising Pharma Holding, Inc. · Drugs · 2025-03-05
  Class II
• Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx On

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied

  Aspen Biopharma Labs Pvt., Ltd. · Drugs · 2025-02-07
  Class II
• Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., H

  YANGZHOU YULOU PAPER PRODUCTS CO., LTD · Drugs · 2025-07-21
  Class II
• Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5

  Cardinal Health Inc. · Drugs · 2025-07-30
  Class II
• Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 10

  Lannett Company Inc. · Drugs · 2025-08-19
  Class II
• 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onl

  B BRAUN MEDICAL INC · Drugs · 2025-06-16
  Class II
• Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Dis

  Strides Pharma, Inc. · Drugs · 2025-07-09
  Class II
• Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL

  A.P. Deauville, LLC · Drugs · 2025-07-10
  Class II
• Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2

  AEQUITA PHARMACY · Drugs · 2025-07-18
  Class II
• Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,

  Ascend Laboratories, LLC · Drugs · 2025-07-09
  Class II
• Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.),

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FS

  QuVa Pharma, Inc. · Drugs · 2025-03-06
  Class II
• Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-

  GenoGenix LLC · Drugs · 2025-07-30
  Class II
• Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, O

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin

  CareFusion 213, LLC · Drugs · 2025-05-15
  Class II
• Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 11

  SV Labs Prescott Corporation · Drugs · 2025-09-25
  Class II
• Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, N

  Imprimis NJOF, LLC · Drugs · 2025-12-18
  Class II
• Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-09-02
  Class II
• Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-3

  Northwind Pharmaceuticals LLC · Drugs · 2025-08-20
  Class II
• Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Sing

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-02-13
  Class II
• Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-01-29
  Class II
• Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 557

  Pharmadel, LLC · Drugs · 2025-04-15
  Class II
• Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy

  Boothwyn Pharmacy LLC · Drugs · 2025-07-09
  Class II
• clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottle

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-10-22
  Class II
• HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Lt

  SKY PACKAGING · Drugs · 2025-01-24
  Class II
• Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE

  Agebox · Drugs · 2025-10-28
  Class II
• Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave,

  FARMAKEIO OUTSOURCING LLC · Drugs · 2025-10-14
  Class II
• WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY

  Blossom Pharmaceuticals · Drugs · 2025-10-31
  Class II
• In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingre

  KABANA SKIN CARE · Drugs · 2025-03-12
  Class II
• Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Mad

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-03-13
  Class II
• CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, N

  Wizcure Pharmaa Private Limited · Drugs · 2025-12-31
  Class II
• Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Br

  Strides Pharma, Inc. · Drugs · 2025-03-05
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran

  FDC Limited · Drugs · 2025-01-23
  Class II
• CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New C

  KENIL HEALTHCARE PRIVATE LIMITED · Drugs · 2025-04-24
  Class II
• TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R

  BSO LLC · Drugs · 2025-04-28
  Class II
• Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, C

  CA BOTANA International, Inc. · Drugs · 2025-10-10
  Class II
• DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174

  DermaRite Industries, LLC · Drugs · 2025-08-27
  Class II
• clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottle

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-10-22
  Class II
• Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919

  Direct Rx · Drugs · 2025-03-07
  Class II
• Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-10-28
  Class II
• Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157

  RemedyRepack Inc. · Drugs · 2025-03-24
  Class II
• Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Privat

  Heritage Pharmaceuticals Inc · Drugs · 2025-10-06
  Class II
• Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, In

  ACCORD HEALTHCARE, INC. · Drugs · 2025-06-20
  Class II
• Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICAL

  The Harvard Drug Group LLC · Drugs · 2025-06-19
  Class II
• Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syri

  Medline Industries, LP · Devices · 2025-09-11
  Class II
• MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3)

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower

  CareFusion 303, Inc. · Devices · 2025-11-20
  Class II
• MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

  Elekta, Inc. · Devices · 2025-12-10
  Class II
• Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun

  Beckman Coulter, Inc. · Devices · 2025-11-10
  Class II
• GE Signa Artist, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

  Medtronic Perfusion Systems · Devices · 2025-09-12
  Class II
• Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

  Abbott · Devices · 2025-03-17
  Class II
• CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Descript

  Drs Vascular, Inc · Devices · 2025-05-16
  Class II
• Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)

  Boston Scientific Corporation · Devices · 2025-08-05
  Class II
• Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219

  Prismatik Dentalcraft, Inc. · Devices · 2025-04-14
  Class II
• IntelliVue MP90. Product Number: M8010A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I

  Applied Medical Technology Inc · Devices · 2025-10-06
  Class II
• LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

  LSL Healthcare Inc. · Devices · 2025-12-22
  Class II
• Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru

  Intuitive Surgical, Inc. · Devices · 2025-12-09
  Class II
• Food Intolerance Test Small

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• IntelliVue MP30. Product Number: M8002A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

  Beckman Coulter Inc. · Devices · 2025-06-26
  Class II
• A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the dista

  Tyber Medical · Devices · 2025-01-21
  Class II
• Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461

  Agilent Technologies Denmark ApS · Devices · 2025-08-11
  Class II
• Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM101020

  Guangzhou Pluslife Biotech Co., Ltd. · Devices · 2025-01-24
  Class II
• Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Intera 1.5T Master/Nova, Model Number: 781106;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub

  Philips North America Llc · Devices · 2025-04-07
  Class II
• Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

  Alcon Research LLC · Devices · 2025-09-30
  Class II
• GYN ROBOTIC PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position

  Vision RT Ltd · Devices · 2025-08-27
  Class II
• SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product D

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

  PHILIPS MEDICAL SYSTEMS · Devices · 2025-09-25
  Class II
• GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

  Cepheid · Devices · 2025-10-30
  Class II
• Medtronic, Simplera Sensor, REF: MMT-5100JD1

  Medtronic MiniMed, Inc. · Devices · 2025-05-07
  Class II
• Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head

  Orascoptic Surgical Acuity · Devices · 2025-07-03
  Class II
• Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-12-12
  Class II
• Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,

  ETAC A/S · Devices · 2025-11-17
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

  Philips Medical Systems Nederland B.V. · Devices · 2025-04-07
  Class II
• Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod

  Olympus Corporation of the Americas · Devices · 2025-10-08
  Class II
• A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal

  Tyber Medical · Devices · 2025-01-21
  Class II
• Philips eL18-4 EMT Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S

  SPINEART SA · Devices · 2025-06-30
  Class II
• Vitamin D-Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RaySta

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product

  ICU Medical Inc. · Devices · 2025-08-06
  Class II
• RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

  Siemens Healthcare Diagnostics Inc · Devices · 2025-06-26
  Class II
• Estrone RIA, REF: DSL8700

  Immunotech A.S. · Devices · 2025-12-15
  Class II
• ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

  TERRAGENE S.A. · Devices · 2025-01-15
  Class II
• Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90

  Medtronic Neuromodulation · Devices · 2025-11-20
  Class II
• Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

  Remote Diagnostic Technologies Ltd. · Devices · 2025-04-15
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 610

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Sof

  American Contract Systems, Inc. · Devices · 2025-01-31
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• i-STAT EG6+ cartridge. List Number: 03P77-25.

  Abbott Point Of Care Inc. · Devices · 2025-08-21
  Class II
• DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

  Pro-Med Instruments Gmbh · Devices · 2025-03-14
  Class II
• Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

  Canon Medical System, USA, INC. · Devices · 2025-12-19
  Class II
• Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr

  Elekta, Inc. · Devices · 2025-12-12
  Class II
• Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• AlternatiV+ Screw-In Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

  Medline Industries, LP · Devices · 2025-12-16
  Class II
• Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Numbe

  Encore Medical, LP · Devices · 2025-06-02
  Class II
• Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

  Bard Peripheral Vascular Inc · Devices · 2025-12-12
  Class II
• Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYND

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-06-12
  Class II
• Brivo MR355, NMRI system

  GE Healthcare (China) Co., Ltd. · Devices · 2025-01-31
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V

  Abbott Diagnostics Scarborough, Inc. · Devices · 2025-03-04
  Class II
• Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-07-23
  Class II
• Candida Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

  Philips North America · Devices · 2025-06-30
  Class II
• OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy

  GE Medical Systems, LLC · Devices · 2025-03-21
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen

  CareFusion 303, Inc. · Devices · 2025-03-11
  Class II
• BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

  Smith & Nephew, Inc. · Devices · 2025-11-24
  Class II
• JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Mod

  North American Rescue LLC. · Devices · 2025-07-01
  Class II
• A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the di

  Tyber Medical · Devices · 2025-01-21
  Class II
• Radiography 7300 C; Model Number: 712037;

  Philips Medical Systems DMC GmbH · Devices · 2025-10-01
  Class II
• Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper

  Lumicell, Inc. · Devices · 2025-07-31
  Class II
• Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

  Merit Medical Systems, Inc. · Devices · 2025-03-14
  Class II
• Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Folsom Metal Products, Inc. · Devices · 2025-08-21
  Class II
• Organic Acids Profile Test Large

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt

  Medtronic, Inc. · Devices · 2025-06-18
  Class II
• BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

  Numed Inc · Devices · 2025-04-21
  Class II
• Allergy Test IgE

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Allergy test Small

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-

  Fresenius Kabi USA, LLC · Devices · 2025-06-24
  Class II
• Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP,

  WASATCH PHOTONICS · Devices · 2025-08-04
  Class II
• LAP CHOLE PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOn

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

  GE Medical Systems China Co., Ltd. · Devices · 2025-05-16
  Class II
• Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

  Steris Corporation · Devices · 2025-06-23
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorin

  CareFusion 303, Inc. · Devices · 2025-01-23
  Class II
• da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1

  Intuitive Surgical, Inc. · Devices · 2025-12-15
  Class II
• IntelliVue Patient Monitor MX800. Product Number: 865240.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Spectral CT. Computed tomography X-ray system.

  Philips North America Llc · Devices · 2025-05-29
  Class II
• 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A

  KCI USA, INC. · Devices · 2025-01-17
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy S

  Noah Medical Corporation · Devices · 2025-09-12
  Class II
• Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-E

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v

  Abbott Laboratories · Devices · 2025-03-18
  Class II
• GI Microbiome Profile XL

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• BostonSight SCLERAL Lens

  Boston Foundation For Sight · Devices · 2025-06-10
  Class II
• Genesis Push-In Suture Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• BostonSight PROSE Lens.

  Boston Foundation For Sight · Devices · 2025-06-10
  Class II
• InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

  Medtronic MiniMed, Inc. · Devices · 2025-03-04
  Class II
• Illegally Marketed

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Cardiosave Rescue. Intra-Aortic Balloon Pump system.

  Datascope Corp. · Devices · 2025-11-04
  Class II
• LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

  ICU Medical, Inc. · Devices · 2025-11-24
  Class II
• Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169

  Baxter Healthcare Corporation · Devices · 2025-09-17
  Class II
• MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

  Remel, Inc · Devices · 2025-02-13
  Class II
• Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F

  MAQUET GMBH · Devices · 2025-07-14
  Class II
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-1

  Encore Medical, LP · Devices · 2025-05-28
  Class II
• Azurion 3 M12 System Code: (1) 722063 (2) 722221

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Descript

  Canary Medical, Inc. · Devices · 2025-05-02
  Class II
• AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect

  Steris Corporation · Devices · 2025-11-19
  Class II
• Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• Philips Azurion system; Software Version Number: R3.1;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-12
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• HPV Antigen Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

  Stryker Corporation · Devices · 2025-01-29
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Descrip

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control se

  TECHNO-PATH MANUFACTURING LTD. · Devices · 2025-10-17
  Class II
• ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

  Fisher Diagnostics · Devices · 2025-03-06
  Class II
• Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve

  Integra LifeSciences Corp. · Devices · 2025-01-10
  Class II
• Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infr

  Howmedica Osteonics Corp. · Devices · 2025-11-12
  Class II
• Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8

  Baxter Healthcare Corporation · Devices · 2025-08-08
  Class II
• Male Fertility Sperm Test for Home Use (Cassette)

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

  Maquet Cardiovascular, LLC · Devices · 2025-08-15
  Class II
• 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Rese

  Belmont Instrument LLC · Devices · 2025-03-31
  Class II
• REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2025-06-03
  Class II
• The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-07-08
  Class II
• Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

  Remel, Inc · Devices · 2025-07-11
  Class II
• Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200

  ICU Medical, Inc. · Devices · 2025-06-03
  Class II
• Welch Allyn Connex Vital Signs Monitor (CVSM):

  Baxter Healthcare Corporation · Devices · 2025-03-24
  Class II
• Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 8

  Encore Medical, LP · Devices · 2025-07-18
  Class II
• myQA iON; Article Number: MQ10-000;

  IBA Dosimetry GmbH · Devices · 2025-04-01
  Class II
• LABOR & DELIVERY PACK, Model Nos LLLD19H

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Zimmer Air Dermatome, Model/Catalog Number: 00880100100

  Zimmer Surgical Inc · Devices · 2025-11-24
  Class II
• Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Philips Incisive CT

  Philips Healthcare (Suzhou) Co., Ltd. · Devices · 2025-12-03
  Class II
• t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

  Tandem Diabetes Care, Inc. · Devices · 2025-07-03
  Class II
• stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Inst

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• GE HealthCare OEC 9900 Elite C-arm Systems.

  GE Medical Systems, LLC · Devices · 2025-07-02
  Class II
• Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque

  Cardinal Health 200, LLC · Devices · 2025-09-18
  Class II
• Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type

  MedicalCommunications GmbH · Devices · 2025-09-09
  Class II
• stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality I

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

  Philips Ultrasound, LLC · Devices · 2025-10-31
  Class II
• Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

  Cepheid · Devices · 2025-11-05
  Class II
• Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RaySta

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• Model Number 40KWFXPLUS.004, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo

  Medtronic, Inc. · Devices · 2025-06-17
  Class II
• SmartPath to dStream for 3.0T, Model Number: 782145;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08

  Cook Incorporated · Devices · 2025-04-17
  Class II
• Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl

  Beckman Coulter Inc. · Devices · 2025-06-12
  Class II
• A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal

  Tyber Medical · Devices · 2025-01-21
  Class II
• Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot

  Beckman Coulter Mishima K.K. · Devices · 2025-04-30
  Class II
• Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/

  Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · Devices · 2025-05-07
  Class II
• Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

  Folsom Metal Products, Inc. · Devices · 2025-08-21
  Class II
• Sperm Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Mo

  Intuitive Surgical, Inc. · Devices · 2025-12-09
  Class II
• Philips C9-5EC Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2025-11-18
  Class II
• Mycoplasma test, IgG and IgM

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F

  HANGZHOU BEVER MEDICAL DEVICES CO., LTD. · Devices · 2025-11-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Allura Xper FD10F; Model Number: 722002;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE

  Olympus Corporation of the Americas · Devices · 2025-07-25
  Class II
• RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatio

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3)

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-04-03
  Class II
• Parasite Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Adrenal Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Refer to RES

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 202

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in

  CardioFocus, Inc. · Devices · 2025-02-07
  Class II
• AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ

  Integra LifeSciences Corp. · Devices · 2025-02-06
  Class II
• Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-

  WANDERCRAFT SAS · Devices · 2025-04-03
  Class II
• Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

  Stryker Spine · Devices · 2025-02-28
  Class II
• DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-04-03
  Class II
• 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Neurotransmitters Plus

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: P

  Zhejiang Luyao Electronics Technology Co., Ltd. · Devices · 2025-01-17
  Class II
• Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emissi

  BigTree Sales Inc. · Devices · 2025-08-29
  Class II
• Allwell Inflation Device, for angiographic use REF: IS-30-A

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

  Steris Corporation · Devices · 2025-06-23
  Class II
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-1

  Encore Medical, LP · Devices · 2025-05-28
  Class II
• i-STAT CG4+ cartridge (white). List Number: 03P85-25.

  Abbott Point Of Care Inc. · Devices · 2025-08-21
  Class II
• Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R

  Aesculap Inc · Devices · 2025-01-31
  Class II
• B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1

  GE Healthcare Finland Oy · Devices · 2025-09-26
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T

  Baxter Healthcare Corporation · Devices · 2025-10-28
  Class II
• Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D

  Defibtech, LLC · Devices · 2025-03-18
  Class II
• ZAP-X Radiosurgery System, Model: 300150

  Zap Surgical Systems · Devices · 2025-07-25
  Class II
• Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu

  Boston Scientific Neuromodulation Corporation · Devices · 2025-07-08
  Class II
• Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• Intera 1.5T Achieva Nova-Dual Product Number: 781173;

  Philips North America · Devices · 2025-05-29
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL P

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986

  Microtek Medical, Inc. · Devices · 2025-04-13
  Class II
• Intera 1.5T Explorer/Nova Dual, Model Number: 781108;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Change Healthcare Cardiology Hemodynamics Software

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2025-05-22
  Class II
• REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Softw

  Heraeus Medical GmbH (Dental Division) · Devices · 2025-12-09
  Class II
• GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086;

  GE Healthcare · Devices · 2025-02-19
  Class II
• Pollen Allergy Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03,

  CareFusion 303, Inc. · Devices · 2025-12-03
  Class II
• Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F

  Boston Scientific Corporation · Devices · 2025-06-10
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 78

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixati

  Tyber Medical · Devices · 2025-01-21
  Class II
• Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Ve

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-29
  Class II
• GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No

  Tecfen Medical · Devices · 2025-04-25
  Class II
• Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

  Fresenius Kabi USA, LLC · Devices · 2025-11-03
  Class II
• Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IM

  Insightra Medical Inc · Devices · 2025-07-19
  Class II
• REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest

  Cellavision AB · Devices · 2025-10-08
  Class II
• GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34

  Encore Medical, LP · Devices · 2025-07-09
  Class II
• Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

  Siemens Healthcare Diagnostics Inc · Devices · 2025-07-07
  Class II
• A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the dista

  Tyber Medical · Devices · 2025-01-21
  Class II
• Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• IntelliVue Patient Monitor MX400. Model Number: 866060

  Philips North America Llc · Devices · 2025-01-15
  Class II
• Alcohol (ALC) Test Saliva

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D

  Carefree Surgical Specialties · Devices · 2025-07-01
  Class II
• This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configurati

  Canon Medical System, USA, INC. · Devices · 2025-09-02
  Class II
• Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Pr

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in

  Philips North America Llc · Devices · 2025-02-25
  Class II
• Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

  Beckman Coulter Inc. · Devices · 2025-08-13
  Class II
• CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a

  GE Healthcare Finland Oy · Devices · 2025-09-26
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLB

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0

  Boston Scientific Corporation · Devices · 2025-08-18
  Class II
• Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-04-09
  Class II
• GE Signa Voyager, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mo

  Prismatik Dentalcraft, Inc. · Devices · 2025-09-30
  Class II
• PACK GENERAL ROBOTIC. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

  C.R. Bard Inc · Devices · 2025-07-17
  Class II
• LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

  GE Medical Systems, LLC · Devices · 2025-09-18
  Class II
• Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4

  Cook Incorporated · Devices · 2025-11-26
  Class II
• Spectrum IQ Infusion Pump, Product Code 3570009

  Baxter Healthcare Corporation · Devices · 2025-07-14
  Class II
• Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Optima XR646 HD. X-Ray imaging system.

  GE Medical Systems, LLC · Devices · 2025-01-28
  Class II
• GE HealthCare OEC 9800.

  GE Medical Systems, LLC · Devices · 2025-07-02
  Class II
• Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN

  Medline Industries, LP · Devices · 2025-12-31
  Class II
• IntelliVue Patient Monitor MX450. Model Number: 866062

  Philips North America Llc · Devices · 2025-01-15
  Class II
• Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-5015

  CORIN MEDICAL, LTD. · Devices · 2025-05-23
  Class II
• Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc

  Abbott Diagnostics Scarborough, Inc. · Devices · 2025-03-04
  Class II
• namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-12
  Class II
• KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

  Microbiologics Inc · Devices · 2025-12-02
  Class II
• Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthet

  Hiossen Inc. · Devices · 2025-01-27
  Class II
• MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-04-14
  Class II
• SmartPath to dStream for 3.0T Model Number (REF): 782145;

  Philips North America · Devices · 2025-06-30
  Class II
• Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

  Diasol, Inc · Devices · 2025-11-05
  Class II
• Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• LAVH PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 34

  Encore Medical, LP · Devices · 2025-07-09
  Class II
• Philips eL18-4 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Softwar

  VIRTUAL INCISION CORPORATION · Devices · 2025-04-23
  Class II
• Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implan

  Hiossen Inc. · Devices · 2025-01-27
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure

  Boston Scientific Corporation · Devices · 2025-03-24
  Class II
• Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel H

  Maquet Cardiovascular, LLC · Devices · 2025-08-06
  Class II
• AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfec

  Steris Corporation · Devices · 2025-11-19
  Class II
• A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software

  Medtronic Neuromodulation · Devices · 2025-12-03
  Class II
• Gut Microbiome Test XL

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

  C.R. Bard Inc · Devices · 2025-11-06
  Class II
• Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-

  Carefree Surgical Specialties · Devices · 2025-07-01
  Class II
• Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

  BD SWITZERLAND SARL · Devices · 2025-05-12
  Class II
• Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

  Medicrea International · Devices · 2025-10-29
  Class II
• Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

  C.R. Bard Inc · Devices · 2025-07-17
  Class II
• Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Se

  Remel, Inc · Devices · 2025-02-12
  Class II
• MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

  PATH · Devices · 2025-11-06
  Class II
• Medshape Universal Joints, REF: DNE-9000-UJ

  Medshape, INC. · Devices · 2025-06-02
  Class II
• REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

  C.R. Bard Inc · Devices · 2025-06-03
  Class II
• Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog

  Olympus Corporation of the Americas · Devices · 2025-11-14
  Class II
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-06-12
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Pet Allergy Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG

  Exactech, Inc. · Devices · 2025-08-15
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPP

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

  Dexcom, Inc. · Devices · 2025-01-27
  Class II
• IntelliVue Patient Monitor MX700. Product Number: 865241.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17

  Microbiologics Inc · Devices · 2025-05-27
  Class II
• BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

  BioFire Diagnostics, LLC · Devices · 2025-04-30
  Class II
• Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile su

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S

  Stryker Corporation · Devices · 2025-02-25
  Class II
• CT 5300; Software Version Number: 4.5, 5.0, 5.1;

  Philips North America Llc · Devices · 2025-10-29
  Class II
• Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06

  Covidien, LP · Devices · 2025-09-25
  Class II
• Urinary Tract Infection Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Welch Allyn CONNEX Accessory Power Management Stand:

  Baxter Healthcare Corporation · Devices · 2025-03-24
  Class II
• BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul

  Becton Dickinson & Co. · Devices · 2025-05-20
  Class II
• IntelliVue Patient Monitor MX550. Model Number: 866066

  Philips North America Llc · Devices · 2025-01-15
  Class II
• ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouth

  Myofunctional Research Company USA · Devices · 2025-10-09
  Class II
• Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect

  Boston Scientific Neuromodulation Corporation · Devices · 2025-06-06
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Allura Xper FD10/10; Model Number: 722027;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

  Diasol, Inc · Devices · 2025-11-05
  Class II
• IntelliVue Patient Monitor MX500. Product Number: 866064.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

  Philips Medical Systems DMC GmbH · Devices · 2025-10-01
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 P

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

  Sophysa · Devices · 2025-11-17
  Class II
• Product Name: Ingenia 3.0T CX; Model Number: 781271;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

  Alcon Research LLC · Devices · 2025-08-05
  Class II
• Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

  Orascoptic Surgical Acuity · Devices · 2025-07-03
  Class II
• Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Ane

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA

  Wilson-Cook Medical Inc. · Devices · 2025-12-18
  Class II
• Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

  Mozarc Medical US LLC · Devices · 2025-04-23
  Class II
• VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated ca

  Merge Healthcare, Inc. · Devices · 2025-02-19
  Class II
• Lactose Intolerance Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

  Ferno-Washington Inc · Devices · 2025-09-11
  Class II
• DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065

  Beckman Coulter Inc. · Devices · 2025-03-17
  Class II
• DIAGNOSTIC NEURO IR TRAY , Model No WENE21

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Baxter Mobile column TruSystem 7500 U, Product Code 1730720

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

  Stryker Corporation · Devices · 2025-06-18
  Class II
• MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• BD BBL TB Stain Kit K, Catalog (REF): 212522

  Becton Dickinson & Co. · Devices · 2025-02-12
  Class II
• Phoroptor VRx Digital Refraction System Model Numbers: 16241

  Reichert, Inc. · Devices · 2025-02-28
  Class II
• Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

  Paragon 28, Inc. · Devices · 2025-10-13
  Class II
• GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

  Ohio Medical Corporation · Devices · 2025-05-08
  Class II
• Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

  Siemens Medical Solutions USA, Inc · Devices · 2025-08-12
  Class II
• Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDO

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 77070806

  Tyber Medical · Devices · 2025-01-21
  Class II
• TENACIO Pump without InhibiZone; UPN: 72404420;

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

  IHB OPERATIONS B.V. · Devices · 2025-03-27
  Class II
• PSA Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264

  Cardinal Health 200, LLC · Devices · 2025-09-18
  Class II
• CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

  Kung Shin Plastics Co. Ltd. · Devices · 2025-01-09
  Class II
• Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

  Abbott Laboratories · Devices · 2025-11-13
  Class II
• Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product De

  THOR Photomedicine Ltd · Devices · 2025-07-24
  Class II
• NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10

  Zimmer, Inc. · Devices · 2025-01-06
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with

  MRIMed Inc. · Devices · 2025-10-13
  Class II
• IntelliVue Patient Monitor MX850. Product Number: 866470.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• BD Pyxis Pro MedStation Main, REF: 1155-00

  CareFusion 303, Inc. · Devices · 2025-09-30
  Class II
• BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM

  BioPro, Inc. · Devices · 2025-09-09
  Class II
• Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

  Diasol, Inc · Devices · 2025-11-05
  Class II
• Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

  Stryker Communications · Devices · 2025-07-15
  Class II
• iBOT PMD with software version 01.05.24. Personal Mobility Device.

  Mobius Mobility LLC · Devices · 2025-04-24
  Class II
• IntelliSpace Cardiovascular, Software 8.0.0.4.

  Philips Medical Systems Nederland B.V. · Devices · 2025-08-08
  Class II
• AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

  GE Medical Systems, SCS · Devices · 2025-09-05
  Class II
• Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050,

  ETAC A/S · Devices · 2025-11-17
  Class II
• Philips C5-2 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Allura Xper FD20; Model Number: 722028;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• DELIVERY PACK , Model No SGDV22D-01 SGDV22E

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

  AVID Medical, Inc. · Devices · 2025-11-14
  Class II
• Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:

  Orthofix U.S. LLC · Devices · 2025-02-20
  Class II
• MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm

  Mozarc Medical US LLC · Devices · 2025-10-17
  Class II
• Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magneti

  ENDOMAGNETICS LTD · Devices · 2025-10-01
  Class II
• ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product N

  Ethicon Endo-Surgery Inc · Devices · 2025-09-11
  Class II
• Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20

  CPM Medical Consultants, LLC. · Devices · 2025-09-17
  Class II
• VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 1

  Merge Healthcare, Inc. · Devices · 2025-02-19
  Class II
• t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a

  Tandem Diabetes Care, Inc. · Devices · 2025-08-05
  Class II
• Biofinity XR Toric Contact Lens

  CooperVision, Inc. · Devices · 2025-06-16
  Class II
• Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 0

  Quest International, Inc. · Devices · 2025-07-17
  Class II
• ICU Medical ChemosafeLock Connecter REF: KL-FNU3

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

  Aesculap AG · Devices · 2025-08-18
  Class II
• DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065.

  Beckman Coulter Inc. · Devices · 2025-03-20
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-E

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• 3M Ranger Irrigation Fluid Warming Set, REF 24750

  3M Company · Devices · 2025-04-22
  Class II
• Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Ingenia 1.5T S Model Number (REF): 781347;

  Philips North America · Devices · 2025-06-30
  Class II
• Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software

  THERAKOS DEVELOPMENT LIMITED · Devices · 2025-05-16
  Class II
• Gut Microbiome Test Small

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

  Applied Medical Resources Corp · Devices · 2025-12-11
  Class II
• Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,

  Philips North America Llc · Devices · 2025-02-25
  Class II
• Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a

  Abbott Molecular, Inc. · Devices · 2025-03-20
  Class II
• Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

  Getinge Disinfection Ab · Devices · 2025-08-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

  VANTIVE US HEALTHCARE LLC · Devices · 2025-07-28
  Class II
• Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web

  St. Jude Medical · Devices · 2025-02-03
  Class II
• Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End

  MicroAire Surgical Instruments, LLC · Devices · 2025-05-07
  Class II
• BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

  Beaver-Visitec International, Inc. · Devices · 2025-12-05
  Class II
• Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained

  Zimmer, Inc. · Devices · 2025-03-24
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-29
  Class II
• Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

  Spark Biomedical Inc · Devices · 2025-07-02
  Class II
• CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic

  Microbiologics Inc · Devices · 2025-01-20
  Class II
• NexxZr T Multi A3.5 W98-16mm, REF: 745451

  Sagemax Bioceramics, Inc. · Devices · 2025-12-11
  Class II
• FoundationOne Companion Diagnostic (F1CDx)

  Foundation Medicine, Inc. · Devices · 2025-04-09
  Class II
• Philips L12-3 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Product Name: Allura Xper FD10C; Model number: 722001;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Philips X6-1 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• SmartPath to dStream for 1.5T, Model Number: 782146;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalo

  Olympus Corporation of the Americas · Devices · 2025-05-06
  Class II
• Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

  Schiller, Ag · Devices · 2025-08-08
  Class II
• BEAR Implant. Model Number: 1000.

  Miach Orthopaedics · Devices · 2025-12-31
  Class II
• 8 in 1 STI Test Kit

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• SIGNA Architect

  GE Medical Systems, LLC · Devices · 2025-05-23
  Class II
• Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Sof

  Rocket Medical Plc · Devices · 2025-11-07
  Class II
• NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shep

  Stryker Corporation · Devices · 2025-10-31
  Class II
• stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-08
  Class II
• Cardiac Workstation 5000; Model Number: 860439;

  Philips North America · Devices · 2025-09-12
  Class II
• Fixone Biocomposite Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (S

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2025-10-20
  Class II
• Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NU

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

  Philips Medical Systems Nederland B.V. · Devices · 2025-02-28
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Baxter TruSystem 7500, Product Code 4091000

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise

  Tyber Medical · Devices · 2025-01-21
  Class II
• Azure S DR MRI SureScan, Product number W3DR01

  Medtronic, Inc. · Devices · 2025-04-29
  Class II
• The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con

  HemoCue AB · Devices · 2025-05-12
  Class II
• NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP

  Stryker Corporation · Devices · 2025-10-31
  Class II
• Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Precision CRF; Model Number: 706400;

  Philips Medical Systems DMC GmbH · Devices · 2025-10-01
  Class II
• Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

  GE Medical Systems, LLC · Devices · 2025-01-28
  Class II
• SM_40HF_B_D_VIR3, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P

  Waismed Ltd. · Devices · 2025-06-05
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Akkermansia Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEM

  BioPro, Inc. · Devices · 2025-09-09
  Class II
• SM_40HF_BDC3, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• MAMMOMAT Inspiration;

  Siemens Medical Solutions USA, Inc · Devices · 2025-10-24
  Class II
• ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version

  Medimaps Group · Devices · 2025-02-03
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

  Cordis US Corp · Devices · 2025-03-04
  Class II
• Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF:

  BD SWITZERLAND SARL · Devices · 2025-05-12
  Class II
• Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,

  Beckman Coulter, Inc. · Devices · 2025-02-03
  Class II
• RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• Food Intolerance Test Medium

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0

  Howmedica Osteonics Corp. · Devices · 2025-08-28
  Class II
• Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-05-15
  Class II
• Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

  Boston Scientific Neuromodulation Corporation · Devices · 2025-07-08
  Class II
• Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x

  Cardinal Health 200, LLC · Devices · 2025-09-18
  Class II
• Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173

  Hologic, Inc. · Devices · 2025-01-08
  Class II
• Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital tran

  Maquet Cardiopulmonary Ag · Devices · 2025-04-30
  Class II
• Philips X8-2t Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP

  Ethicon Endo Surgery, LLC · Devices · 2025-03-07
  Class II
• REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2025-07-08
  Class II
• GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; M

  Wipro GE Healthcare Private Ltd. · Devices · 2025-09-05
  Class II
• Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive d

  Trinity Biotech USA · Devices · 2025-07-22
  Class II
• Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

  Mozarc Medical US LLC · Devices · 2025-04-23
  Class II
• Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr

  Medtronic, Inc. · Devices · 2025-06-18
  Class II
• Product Name: Ingenia 1.5T CX; Model Number: 781262;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Allura Xper FD10; Model Number: 722003;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn

  Microbiologics Inc · Devices · 2025-01-20
  Class II
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-06-12
  Class II
• 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int

  QUANTUM SURGICAL SAS · Devices · 2025-05-23
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 55

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

  Canon Medical System, USA, INC. · Devices · 2025-10-16
  Class II
• PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

  Microbiologics Inc · Devices · 2025-06-27
  Class II
• Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10

  ICU Medical Inc. · Devices · 2025-08-06
  Class II
• Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects ph

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

  Medtronic MiniMed, Inc. · Devices · 2025-06-16
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

  Philips North America · Devices · 2025-06-30
  Class II
• ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• Baxter Stationary column TruSystem 7500, Product Code 1717020

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

  GE Healthcare GmbH · Devices · 2025-11-03
  Class II
• LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• SHIMADZU RF.004, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• HemosIL LMW Heparin Controls; Part Number: 0020300200;

  Instrumentation Laboratory · Devices · 2025-02-03
  Class II
• Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; inv

  Remel, Inc · Devices · 2025-05-01
  Class II
• Fixone Hybrid Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• Ami HTX.

  Spectral Instruments Inc · Devices · 2025-05-13
  Class II
• Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Co

  Thoratec LLC · Devices · 2025-10-09
  Class II
• Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

  Olympus Corporation of the Americas · Devices · 2025-05-05
  Class II
• Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software

  Tecfen Medical · Devices · 2025-04-25
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Tri

  Terumo Cardiovascular Systems Corporation · Devices · 2025-05-28
  Class II
• Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psor

  Daavlin Distributing Company · Devices · 2025-12-10
  Class II
• UROSKOP Omnia Max. Model Number: 10762473

  Siemens Medical Solutions USA, Inc · Devices · 2025-06-04
  Class II
• Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Philips V6-2 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript

  Dentsply IH, Inc. · Devices · 2025-07-24
  Class II
• Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

  Cardinal Health 200, LLC · Devices · 2025-05-02
  Class II
• Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A

  Waismed Ltd. · Devices · 2025-06-05
  Class II
• Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Focalyx Fusion

  Focalyx Technologies, LLC. · Devices · 2025-12-23
  Class II
• SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

  Merit Medical Systems, Inc. · Devices · 2025-01-27
  Class II
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

  Beckman Coulter, Inc. · Devices · 2025-04-23
  Class II
• KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

  Microbiologics Inc · Devices · 2025-11-13
  Class II
• Change Healthcare Radiology Solutions software version 14.2.2

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2025-08-13
  Class II
• Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US P

  KCI USA, INC. · Devices · 2025-01-17
  Class II
• B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introduce

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• MAMMOMAT Fusion;

  Siemens Medical Solutions USA, Inc · Devices · 2025-10-24
  Class II
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-06-04
  Class II
• STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, S

  Diagnostica Stago, Inc. · Devices · 2025-07-21
  Class II
• A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fract

  Tyber Medical · Devices · 2025-01-21
  Class II
• Halyard, EP LAB PK. Catalog Number: ESJH009-03.

  AVID Medical, Inc. · Devices · 2025-11-14
  Class II
• CYSTO , Model No SACY80R

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• LAPAROSCOPIC GYN. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12

  Merge Healthcare, Inc. · Devices · 2025-02-19
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• SIGNA Creator, SIGNA Explorer, NMRI systems

  GE Healthcare (China) Co., Ltd. · Devices · 2025-01-31
  Class II
• Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software V

  Exactech, Inc. · Devices · 2025-09-05
  Class II
• IntelliVue MP2. Product Number: M8102A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANC

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

  Ethicon Endo Surgery, LLC · Devices · 2025-03-07
  Class II
• Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK

  Medline Industries, LP · Devices · 2025-11-21
  Class II
• Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-06-12
  Class II
• DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20

  Mozarc Medical US LLC · Devices · 2025-10-17
  Class II
• Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)008

  Philips Medical Systems (Cleveland) Inc · Devices · 2025-08-05
  Class II
• LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C

  Physio-Control, Inc. · Devices · 2025-07-22
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461

  Agilent Technologies Denmark ApS · Devices · 2025-08-11
  Class II
• Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicate

  Argon Medical Devices, Inc · Devices · 2025-09-12
  Class II
• Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit

  AVID Medical, Inc. · Devices · 2025-03-31
  Class II
• 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

  Baxter Healthcare Corporation · Devices · 2025-05-09
  Class II
• Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY C

  Medline Industries, LP · Devices · 2025-12-16
  Class II
• STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent

  Diagnostica Stago, Inc. · Devices · 2025-05-21
  Class II
• Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i

  Philips North America Llc · Devices · 2025-02-25
  Class II
• DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fl

  DeRoyal Industries Inc · Devices · 2025-01-15
  Class II
• Intera 1.5T Explorer/Nova Dual Product Number: 781108;

  Philips North America · Devices · 2025-05-29
  Class II
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-06-12
  Class II
• Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-07-30
  Class II
• Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.

  Orascoptic Surgical Acuity · Devices · 2025-07-03
  Class II
• VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18

  Boston Scientific Corporation · Devices · 2025-06-10
  Class II
• Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H

  GE Medical Systems, LLC · Devices · 2025-03-06
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

  Dexcom, Inc. · Devices · 2025-01-27
  Class II
• Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX ser

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-05-09
  Class II
• Food Sensitivity Test Large

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

  C.R. Bard Inc · Devices · 2025-11-06
  Class II
• Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;

  Spiggle & Theis Mt Gmbh · Devices · 2025-06-27
  Class II
• REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

  Vortex Surgical Inc. · Devices · 2025-11-19
  Class II
• SmartPath to dStream for 1.5T¿; Product Number: 782146;

  Philips North America · Devices · 2025-05-29
  Class II
• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Numbe

  Encore Medical, LP · Devices · 2025-06-02
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

  Philips North America Llc · Devices · 2025-08-13
  Class II
• Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubin

  ICU Medical Inc. · Devices · 2025-08-06
  Class II
• Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

  PHILIPS MEDICAL SYSTEMS · Devices · 2025-09-25
  Class II
• Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga.

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08

  Cook Incorporated · Devices · 2025-04-17
  Class II
• PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

  Limacorporate S.p.A · Devices · 2025-05-19
  Class II
• Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

  B-K Medical A/S · Devices · 2025-10-09
  Class II
• Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3

  DSAART LLC · Devices · 2025-09-26
  Class II
• HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

  Advanced Bionics, LLC · Devices · 2025-03-05
  Class II
• QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

  Quidel Corporation · Devices · 2025-06-17
  Class II
• Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,

  RECORDATI RARE DISEASES INC. · Devices · 2025-06-11
  Class II
• VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Devic

  Boston Scientific Corporation · Devices · 2025-06-10
  Class II
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-06-04
  Class II
• Model Number 40KW-FX.899, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral device

  Pentax of America Inc · Devices · 2025-01-29
  Class II
• CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU

  Beckman Coulter, Inc. · Devices · 2025-09-08
  Class II
• SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th

  Philips Respironics, Inc. · Devices · 2025-10-07
  Class II
• Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning

  Ultra Clean Systems, Inc. · Devices · 2025-03-31
  Class II
• Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int

  Cordis US Corp · Devices · 2025-02-07
  Class II
• Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Mod

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• MOSAIQ Oncology Information System

  Elekta, Inc. · Devices · 2025-01-15
  Class II
• VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG

  Luminex Corporation · Devices · 2025-04-16
  Class II
• iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-

  Theken Companies LLC · Devices · 2025-09-11
  Class II
• Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

  Meridian Bioscience Inc · Devices · 2025-10-07
  Class II
• LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

  Straumann USA LLC · Devices · 2025-10-17
  Class II
• Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Philips S5-1 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-05
  Class II
• Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Ver

  Aesculap Inc · Devices · 2025-09-24
  Class II
• Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

  Trividia Health, Inc. · Devices · 2025-10-07
  Class II
• Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

  OSSTEM Implant Co., Ltd. · Devices · 2025-08-26
  Class II
• Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog

  Becton Dickinson & Co. · Devices · 2025-09-23
  Class II
• Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain

  Abbott Molecular, Inc. · Devices · 2025-04-28
  Class II
• CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

  American Contract Systems Inc · Devices · 2025-02-04
  Class II
• Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-1

  Encore Medical, LP · Devices · 2025-05-28
  Class II
• Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3.

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Vivoo Protein Test

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACRO

  Boston Scientific Corporation · Devices · 2025-06-10
  Class II
• PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

  Orthofix U.S. LLC · Devices · 2025-06-24
  Class II
• Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

  AVID Medical, Inc. · Devices · 2025-11-14
  Class II
• ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Philips S7-2 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Medline Sterile Water, USP, 100mL, REF RDI30295

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio

  Beckman Coulter, Inc. · Devices · 2025-11-07
  Class II
• FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

  Boston Scientific Corporation · Devices · 2025-06-25
  Class II
• Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Mycotoxin Panel Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Food Sensitivity Test Small

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• Product: STA Liatest D-Di; REF: 00515;

  Diagnostica Stago, Inc. · Devices · 2025-09-12
  Class II
• Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

  ICU Medical, Inc. · Devices · 2025-12-15
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz.

  Osteotec Limited · Devices · 2025-06-18
  Class II
• MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

  Philips North America · Devices · 2025-06-30
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4)

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

  Beta Bionics, Inc. · Devices · 2025-08-13
  Class II
• STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a

  Diagnostica Stago, Inc. · Devices · 2025-07-21
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

  AVID Medical, Inc. · Devices · 2025-11-14
  Class II
• A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fr

  Tyber Medical · Devices · 2025-01-21
  Class II
• Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure g

  Boston Scientific Corporation · Devices · 2025-03-24
  Class II
• TENACIO Pump with InhibiZone; UPN: 72404429;

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000

  Physio-Control, Inc. · Devices · 2025-07-22
  Class II
• Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Allergy test Small

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

  Philips North America · Devices · 2025-06-30
  Class II
• Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-10-06
  Class II
• VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrate

  Merge Healthcare, Inc. · Devices · 2025-02-19
  Class II
• Intera 1.5T Achieva IT Nova Product Number: 781175

  Philips North America · Devices · 2025-05-29
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Mod

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

  Beckman Coulter, Inc. · Devices · 2025-02-27
  Class II
• Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 6032001010

  Zimmer Surgical Inc · Devices · 2025-12-24
  Class II
• Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0

  Spacelabs Healthcare, Inc. · Devices · 2025-09-05
  Class II
• Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap,

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• Peptic Ulcer Test (H, pylori)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45

  Intuitive Surgical, Inc. · Devices · 2025-12-30
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and

  Cook Incorporated · Devices · 2025-04-17
  Class II
• The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop leng

  Implant Direct Sybron Manufacturing LLC · Devices · 2025-05-01
  Class II
• Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

  Abbott Medical · Devices · 2025-10-06
  Class II
• Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca

  Zimmer, Inc. · Devices · 2025-09-26
  Class II
• SIGNA MR355, SIGNA MR360, NMRI system

  GE Healthcare (China) Co., Ltd. · Devices · 2025-01-31
  Class II
• TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

  VANTIVE US HEALTHCARE LLC · Devices · 2025-07-28
  Class II
• Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic a

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot

  Beckman Coulter Mishima K.K. · Devices · 2025-04-30
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged an

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

  Baxter Healthcare Corporation · Devices · 2025-05-12
  Class II
• GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001;

  GE Healthcare · Devices · 2025-02-19
  Class II
• Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N

  Aesculap Inc · Devices · 2025-09-24
  Class II
• Heavy Metals Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

  Medtronic Perfusion Systems · Devices · 2025-10-20
  Class II
• GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-04-15
  Class II
• stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

  Healthmark Industries Co., Inc. · Devices · 2025-05-02
  Class II
• ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• SM_40HF_B_D_VIR3.004, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessor

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

  Philips North America Llc · Devices · 2025-04-01
  Class II
• INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-04-04
  Class II
• Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste

  Dexcom, Inc. · Devices · 2025-05-05
  Class II
• A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the dista

  Tyber Medical · Devices · 2025-01-21
  Class II
• Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

  Philips North America Llc · Devices · 2025-10-29
  Class II
• Intera 1.0T Omni/Stellar, Model Number: 781102;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

  Philips North America Llc · Devices · 2025-08-13
  Class II
• Fructose Intolerance Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V

  Abbott Diagnostics Scarborough, Inc. · Devices · 2025-03-04
  Class II
• LAPAROSCOPIC TRAY. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con

  Cardinal Health 200, LLC · Devices · 2025-05-13
  Class II
• Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU140

  Medistim Asa · Devices · 2025-09-26
  Class II
• Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffu

  Immuno-Mycologics, Inc · Devices · 2025-02-10
  Class II
• Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size

  DSAART LLC · Devices · 2025-09-26
  Class II
• ROBOTIC URO/GYN PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

  ICU Medical, Inc. · Devices · 2025-12-19
  Class II
• Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

  Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · Devices · 2025-06-18
  Class II
• Vortex Surgical I2 Injection Kit, VS0500

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019

  ORTOMA AB · Devices · 2025-07-28
  Class II
• ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

  ICU Medical, Inc. · Devices · 2025-12-15
  Class II
• Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro

  Olympus Corporation of the Americas · Devices · 2025-10-17
  Class II
• ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Model Number 40KWFXPLUS.889, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.

  Cardinal Health 200, LLC · Devices · 2025-12-26
  Class II
• Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

  CORNEAT VISION, LTD. · Devices · 2025-08-18
  Class II
• IntelliVue Patient Monitor MX500. Model Number: 866064

  Philips North America Llc · Devices · 2025-01-15
  Class II
• BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA

  BD SWITZERLAND SARL · Devices · 2025-05-12
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Trichomonas Vaginalis test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Onco

  Philips North America Llc · Devices · 2025-08-13
  Class II
• ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-

  Cardinal Health 200, LLC · Devices · 2025-11-12
  Class II
• META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

  Smith & Nephew, Inc. · Devices · 2025-03-18
  Class II
• CareLink Clinic, REF: MMT-7350

  Medtronic MiniMed, Inc. · Devices · 2025-10-21
  Class II
• Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.

  AVID Medical, Inc. · Devices · 2025-03-31
  Class II
• Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

  Beckman Coulter, Inc. · Devices · 2025-11-26
  Class II
• Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

  AVID Medical, Inc. · Devices · 2025-08-04
  Class II
• Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• Genesis Knotless Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS T

  GOLD STAR DISTRIBUTION INC · Devices · 2025-12-26
  Class II
• Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

  Beckman Coulter, Inc. · Devices · 2025-11-26
  Class II
• GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-12-24
  Class II
• stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades

  Stryker Corporation · Devices · 2025-01-08
  Class II
• Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Sof

  Rocket Medical Plc · Devices · 2025-11-07
  Class II
• ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tub

  Applied Medical Technology Inc · Devices · 2025-08-12
  Class II
• Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to

  TECHNO-PATH MANUFACTURING LTD. · Devices · 2025-10-17
  Class II
• Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

  Philips North America · Devices · 2025-06-30
  Class II
• SIGNA Architect AIR

  GE Medical Systems, LLC · Devices · 2025-05-23
  Class II
• Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

  Jewel Precision Sheet Metal & Machining Co, Inc. · Devices · 2025-05-23
  Class II
• Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D

  Carefree Surgical Specialties · Devices · 2025-07-01
  Class II
• Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Conveni

  American Contract Systems, Inc. · Devices · 2025-01-31
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 -

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

  Datascope Corp. · Devices · 2025-11-04
  Class II
• BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

  C.R. Bard Inc · Devices · 2025-11-06
  Class II
• LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Philips 3D9-3v Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No soft

  Tecfen Medical · Devices · 2025-04-25
  Class II
• Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

  Contamac Solutions, Inc. · Devices · 2025-05-15
  Class II
• Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2025-08-06
  Class II
• Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-01-09
  Class II
• ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.

  Philips North America · Devices · 2025-12-03
  Class II
• (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES

  CareFusion 303, Inc. · Devices · 2025-01-08
  Class II
• PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010

  Cerapedics, Inc. · Devices · 2025-12-29
  Class II
• Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Sa

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2025-10-20
  Class II
• IntelliVue MP50. Product Number: M8004A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Pr

  INSTITUT GEORGES LOPEZ · Devices · 2025-03-13
  Class II
• Artix MT Thrombectomy Device, REF: 32-102

  Inari Medical - Oak Canyon · Devices · 2025-04-08
  Class II
• Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 13

  CareFusion 303, Inc. · Devices · 2025-09-30
  Class II
• The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len

  Maquet Cardiovascular, LLC · Devices · 2025-03-20
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-05-05
  Class II
• Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• SIBO Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W B

  GOLD STAR DISTRIBUTION INC · Devices · 2025-12-26
  Class II
• Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-02-14
  Class II
• MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended t

  CARIS LIFE SCIENCES · Devices · 2025-06-17
  Class II
• Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Soft

  Kico Knee Innovation Company · Devices · 2025-09-19
  Class II
• Phoroptor VRx Digital Refraction System Model Numbers: 16242

  Reichert, Inc. · Devices · 2025-02-28
  Class II
• Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a s

  Community Products, LLC · Devices · 2025-12-18
  Class II
• Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Pr

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medl

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Upgrade to MR 7700 Model Number (REF): 782130;

  Philips North America · Devices · 2025-06-30
  Class II
• 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI

  CareFusion 303, Inc. · Devices · 2025-01-08
  Class II
• BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ

  Aesculap Inc · Devices · 2025-01-31
  Class II
• MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-05
  Class II
• Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.

  Beyond Laser Systems, LLC · Devices · 2025-06-30
  Class II
• Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Mo

  Intuitive Surgical, Inc. · Devices · 2025-12-09
  Class II
• Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

  Philips North America Llc · Devices · 2025-08-13
  Class II
• bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

  B-K Medical A/S · Devices · 2025-10-09
  Class II
• Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 806

  Alcon Research LLC · Devices · 2025-09-15
  Class II
• Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, R

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-24
  Class II
• ICU Medical ChemoLock Port REF: CL2100

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Vers

  Dentsply IH, Inc. · Devices · 2025-07-24
  Class II
• MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm

  Mozarc Medical US LLC · Devices · 2025-10-17
  Class II
• Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

  ESAOTE S.P.A. · Devices · 2025-03-14
  Class II
• ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Produ

  ICU Medical Inc. · Devices · 2025-08-06
  Class II
• Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 725

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Merit Medical , Custom Manifold Kit REF: K09-13203A

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• Allura CV20 System Code: 722031

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic

  Pentax of America Inc · Devices · 2025-01-29
  Class II
• Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

  PYRAMES INC · Devices · 2025-02-24
  Class II
• SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spac

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

  Mobius Imaging, LLC · Devices · 2025-12-04
  Class II
• MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK,

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• PhenoMATRIX

  Copan WASP · Devices · 2025-05-06
  Class II
• Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

  Beckman Coulter, Inc. · Devices · 2025-10-01
  Class II
• Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

  Philips North America · Devices · 2025-06-30
  Class II
• namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-12
  Class II
• Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2025-01-30
  Class II
• ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra

  ImaCor Inc. · Devices · 2025-08-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v

  Abbott Laboratories · Devices · 2025-03-18
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

  Abbott Medical · Devices · 2025-10-06
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

  Meridian Bioscience Inc · Devices · 2025-10-07
  Class II
• Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S

  SPINEART SA · Devices · 2025-06-30
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

  Maquet Cardiovascular, LLC · Devices · 2025-08-15
  Class II
• Philips X7-2t Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

  Medtronic Perfusion Systems · Devices · 2025-10-03
  Class II
• Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

  Mozarc Medical US LLC · Devices · 2025-04-23
  Class II
• Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

  B-K Medical A/S · Devices · 2025-10-09
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear,

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• IntelliVue MP80. Product Number: M8008A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• GYN LAPAROSCOPY PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc

  Greiner Bio-One North America, Inc. · Devices · 2025-08-19
  Class II
• Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Blood/MacConkey Biplate 100/PK, Product Number R02049

  Remel, Inc · Devices · 2025-07-11
  Class II
• Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Soft

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Mo

  Tyber Medical · Devices · 2025-12-19
  Class II
• Enterprise 1.5T, Model Number: 781145;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-06-10
  Class II
• AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for us

  DERMASENSOR INC · Devices · 2025-10-13
  Class II
• MIM software; System, Image Processing, Radiological

  MIM Software Inc · Devices · 2025-02-19
  Class II
• GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• MicroScan Neg MIC 3J REF C54814

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22

  Defibtech, LLC · Devices · 2025-03-18
  Class II
• Medical convenience kits IHDC30R D AND C PACK

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number

  Stryker Corporation · Devices · 2025-02-25
  Class II
• CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/C

  Kung Shin Plastics Co. Ltd. · Devices · 2025-01-09
  Class II
• namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-12
  Class II
• Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAW

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-05-23
  Class II
• Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjus

  Community Products, LLC · Devices · 2025-12-18
  Class II
• MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5

  ICU Medical Inc. · Devices · 2025-08-06
  Class II
• IntelliVue Patient Monitor MX100. Product Number: 867033.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables t

  Richard Wolf GmbH · Devices · 2025-04-09
  Class II
• Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Allura Xper FD10/10; Model Number: 722011;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• Intestinal Worms Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043

  Baxter Healthcare Corporation · Devices · 2025-05-06
  Class II
• D-Dimer Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micro

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible w

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

  Phasor Health, LLC · Devices · 2025-03-21
  Class II
• Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 77070804

  Tyber Medical · Devices · 2025-01-21
  Class II
• ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿

  Thoratec LLC · Devices · 2025-10-09
  Class II
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-06-10
  Class II
• Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2

  GE Healthcare · Devices · 2025-02-19
  Class II
• Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

  Alcon Research LLC · Devices · 2025-08-05
  Class II
• Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or

  Spectrum Medical Ltd. · Devices · 2025-03-19
  Class II
• Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Folsom Metal Products, Inc. · Devices · 2025-08-21
  Class II
• Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms

  GE Healthcare Finland Oy · Devices · 2025-09-26
  Class II
• Discovery XR656 HD. X-Ray imaging system.

  GE Medical Systems, LLC · Devices · 2025-01-28
  Class II
• Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control

  Microbiologics Inc · Devices · 2025-02-20
  Class II
• Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version

  Abbott Diagnostics Scarborough, Inc. · Devices · 2025-03-04
  Class II
• LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Ret

  Synthes (USA) Products LLC · Devices · 2025-09-26
  Class II
• Philips X5-1 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Si

  CooperVision, Inc. · Devices · 2025-08-22
  Class II
• interventional fluoroscopic x-ray system

  Siemens Medical Solutions USA, Inc · Devices · 2025-05-15
  Class II
• Washer Disinfector Aquadis 56; Model Number: 56M

  Getinge Disinfection Ab · Devices · 2025-04-02
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP12525

  US Endodontics, LLC · Devices · 2025-01-02
  Class II
• Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu

  Microbiologics Inc · Devices · 2025-02-20
  Class II
• CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Alphenix INFX-8000F, interventional fluoroscopic x-ray system

  Canon Medical System, USA, INC. · Devices · 2025-12-19
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2.

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche

  Omnicell, Inc. · Devices · 2025-02-20
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-S

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Philips S8-3t Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 6050001010

  Zimmer Surgical Inc · Devices · 2025-12-24
  Class II
• Basic Biopsy Tray, Item Number NMBP44L

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

  OSSTEM Implant Co., Ltd. · Devices · 2025-08-26
  Class II
• CYSTO PACK , Model N. HKCY31A

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y

  BD SWITZERLAND SARL · Devices · 2025-05-12
  Class II
• IntelliVue MP40. Product Number: M8003A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71

  LeMaitre Vascular, Inc. · Devices · 2025-09-02
  Class II
• restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for

  Conformis Inc. · Devices · 2025-03-25
  Class II
• Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version

  Encore Medical, LP · Devices · 2025-07-18
  Class II
• Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

  Philips North America · Devices · 2025-06-30
  Class II
• Diabetes HbA1c Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-19
  Class II
• Strep Selective II Agar, Product Number R01859

  Remel, Inc · Devices · 2025-07-11
  Class II
• 5008X CAREsystem +CLiC +CDX;

  Fresenius Medical Care Holdings, Inc. · Devices · 2025-10-25
  Class II
• Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

  Beckman Coulter Inc. · Devices · 2025-08-13
  Class II
• BD Trucount Controls, 30 Test - REF: 340335

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2025-07-08
  Class II
• Olympus OER-Elite

  Aizu Olympus Co., Ltd. · Devices · 2025-10-31
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa

  Siemens Healthcare Diagnostics Inc · Devices · 2025-03-19
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P

  Medtronic Neuromodulation · Devices · 2025-03-04
  Class II
• SM_40HF_BDC, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• Paradigm REF: MMT-712 and MMT-715

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) an

  XTANT Medical Holdings, Inc · Devices · 2025-01-03
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KI

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

  Philips North America · Devices · 2025-10-27
  Class II
• Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically fo

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• AlluraXperFD20/10 System Code: (1) 722029

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No

  ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY · Devices · 2025-03-03
  Class II
• RADPRO MOBILE, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (

  Abbott Molecular, Inc. · Devices · 2025-04-28
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu

  GE Medical Systems, LLC · Devices · 2025-08-22
  Class II
• A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for

  Tyber Medical · Devices · 2025-01-21
  Class II
• ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO,

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthet

  Hiossen Inc. · Devices · 2025-01-27
  Class II
• Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-19
  Class II
• Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01

  Quest International, Inc. · Devices · 2025-10-01
  Class II
• BORN ON ARRIVAL KIT , Model No LLBN11B

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor

  Draeger Medical Systems, Inc. · Devices · 2025-01-14
  Class II
• Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-07-15
  Class II
• CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

  Smiths Medical ASD, Inc. · Devices · 2025-02-14
  Class II
• Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

  Philips North America Llc · Devices · 2025-08-13
  Class II
• Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-01-03
  Class II
• Candida Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Che

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers

  Olympus Corporation of the Americas · Devices · 2025-04-04
  Class II
• Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

  Philips North America Llc · Devices · 2025-03-10
  Class II
• Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Lazervida 10W diode laser cutter and engraver with Lazervida shield.

  Flux Technology Inc. · Devices · 2025-02-19
  Class II
• Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Sl

  Philips North America Llc · Devices · 2025-08-13
  Class II
• IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure

  Boston Scientific Corporation · Devices · 2025-03-24
  Class II
• GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; M

  Wipro GE Healthcare Private Ltd. · Devices · 2025-09-05
  Class II
• Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

  Biomet, Inc. · Devices · 2025-09-09
  Class II
• Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

  Mozarc Medical US LLC · Devices · 2025-04-23
  Class II
• Pentax Medical Video Processor; Model Number: EPK-i8020c;

  Pentax of America Inc · Devices · 2025-07-16
  Class II
• Syphilis Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data proce

  Medical Information Technology, Inc. · Devices · 2025-02-05
  Class II
• DxI 9000 Access Immunoassay Analyzer, Part Number C11137

  Beckman Coulter, Inc. · Devices · 2025-09-19
  Class II
• Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I

  Applied Medical Technology Inc · Devices · 2025-10-06
  Class II
• Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.

  Philips North America · Devices · 2025-12-03
  Class II
• Iodine Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constr

  Zimmer, Inc. · Devices · 2025-03-24
  Class II
• GENERAL LAPAROSCOPY TRAY. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.

  Stryker GmbH · Devices · 2025-05-22
  Class II
• MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-014

  REPLIGEN CORPORATION · Devices · 2025-12-10
  Class II
• Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG

  Rocket Medical Plc · Devices · 2025-11-07
  Class II
• MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Philips XL14-3 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three w

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system c

  bioMerieux, Inc. · Devices · 2025-06-26
  Class II
• MPOX Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Ca

  Zimmer, Inc. · Devices · 2025-09-26
  Class II
• Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP R

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Allura Xper FD20/20; Model Number: 722038;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

  Becton Dickinson & Company · Devices · 2025-10-14
  Class II
• Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

  PHILIPS MEDICAL SYSTEMS · Devices · 2025-09-25
  Class II
• BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702.

  Becton Dickinson & Co. · Devices · 2025-09-23
  Class II
• Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Produc

  LEASEIR TECHNOLOGIES SLU · Devices · 2025-12-15
  Class II
• Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Tur

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.

  Beyond Laser Systems, LLC · Devices · 2025-06-30
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH K

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

  Philips North America · Devices · 2025-06-30
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog

  Alcon Research LLC · Devices · 2025-04-28
  Class II
• Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product

  Medtronic, Inc. · Devices · 2025-10-29
  Class II
• IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for

  Medtronic Xomed, Inc. · Devices · 2025-07-17
  Class II
• Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I

  Applied Medical Technology Inc · Devices · 2025-10-06
  Class II
• GI Microbiome Profile Small

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-19
  Class II
• GEN LAPAROSCOPY PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,

  IMRIS Imaging Inc · Devices · 2025-12-08
  Class II
• Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

  Covidien, LP · Devices · 2025-09-25
  Class II
• GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann

  Aesculap Inc · Devices · 2025-01-31
  Class II
• Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in

  Biofire Defense · Devices · 2025-07-10
  Class II
• Allura Xper FD10/10; Model Number: 722005;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible wit

  Copan Italia · Devices · 2025-10-29
  Class II
• ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Philips C5-1 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

  Abbott Point Of Care Inc. · Devices · 2025-08-21
  Class II
• ICU Medical ChemoLock Bag Spike REF: CL-10

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2025-08-15
  Class II
• Product Name: Ingenia 1.5T S; Model Number: 781347;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi

  Olympus Corporation of the Americas · Devices · 2025-10-06
  Class II
• Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

  Boston Scientific Corporation · Devices · 2025-08-18
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

  Alcon Research LLC · Devices · 2025-08-05
  Class II
• Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 320

  Total Joint Orthopedics, Inc. · Devices · 2025-09-23
  Class II
• Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following softwar

  Medtronic, Inc. · Devices · 2025-06-17
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

  SCIENCE & BIO MATERIALS · Devices · 2025-04-07
  Class II
• Intera 1.5T Omni/Stellar, Model Number: 781104;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Parasite Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R,

  Diagnostica Stago, Inc. · Devices · 2025-07-21
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

  Philips North America Llc · Devices · 2025-05-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is

  Berkeley Advanced Biomaterials, LLC · Devices · 2025-09-02
  Class II
• Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Sperm Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-02-14
  Class II
• Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen

  Cardinal Health 200, LLC · Devices · 2025-05-02
  Class II
• Intera 0.5T Standard, Model Number: 781101;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Sof

  Rocket Medical Plc · Devices · 2025-11-07
  Class II
• EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, S

  CORNEAT VISION, LTD. · Devices · 2025-08-18
  Class II
• ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-04-15
  Class II
• Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L;

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

  ICU Medical, Inc. · Devices · 2025-11-24
  Class II
• Trial Tampon Box; Model Number: FG-TMP-REF04050504;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

  Baxter Healthcare Corporation · Devices · 2025-11-28
  Class II
• ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• DHEA Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

  Philips North America · Devices · 2025-06-30
  Class II
• RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatio

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible w

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• MiniMed insulin pump, REF: 620G (MMT-1750)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• Allura Xper FD20; Model Number: 722012;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-E

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• Model Number 40KWMOBILE3.899, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software V

  Intuitive Surgical, Inc. · Devices · 2025-02-26
  Class II
• Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperth

  Belmont Instrument LLC · Devices · 2025-03-31
  Class II
• Serotonin Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• LAPAROSCOPY PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-07-29
  Class II
• Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

  ICU Medical Inc. · Devices · 2025-12-19
  Class II
• Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1

  Spacelabs Healthcare, Inc. · Devices · 2025-09-05
  Class II
• Azurion 7 M20. Fluoroscopic X-Ray System.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-06-04
  Class II
• Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

  CooperSurgical, Inc. · Devices · 2025-06-11
  Class II
• Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334

  Merit Medical Systems, Inc. · Devices · 2025-06-05
  Class II
• BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr

  C.R. Bard Inc · Devices · 2025-06-03
  Class II
• Female Fertility Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microi

  Iantrek Inc. · Devices · 2025-09-06
  Class II
• Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I

  Applied Medical Technology Inc · Devices · 2025-10-06
  Class II
• KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F

  Klinika Mdical Gmb · Devices · 2025-04-04
  Class II
• Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP

  Medline Industries, LP · Devices · 2025-12-16
  Class II
• DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us

  Beckman Coulter Inc. · Devices · 2025-09-22
  Class II
• BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer

  BD SWITZERLAND SARL · Devices · 2025-06-16
  Class II
• Gut Microbiome Test Mega

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

  Tornier S.A.S. · Devices · 2025-04-10
  Class II
• Model Number 40KWFXPLUS.005, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

  Meridian Bioscience Inc · Devices · 2025-12-05
  Class II
• Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Ki

  Thoratec LLC · Devices · 2025-10-09
  Class II
• Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Mon

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection i

  Diagnostica Stago, Inc. · Devices · 2025-12-15
  Class II
• Enhanced Verify Evaluation Handset (CFN HH90130FA)

  Medtronic Neuromodulation · Devices · 2025-04-03
  Class II
• IntelliVue Multi Measurement Server X2. Product Number: M3002A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Philips L12-4 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT

  Philips North America Llc · Devices · 2025-08-13
  Class II
• Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461

  Agilent Technologies Denmark ApS · Devices · 2025-08-11
  Class II
• Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

  Brainlab AG · Devices · 2025-02-10
  Class II
• Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP

  Bridge to Life Ltd · Devices · 2025-06-12
  Class II
• Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

  Pivotal Health Solutions, Inc. · Devices · 2025-10-09
  Class II
• Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

  Beckman Coulter Inc. · Devices · 2025-08-13
  Class II
• Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4

  Beckman Coulter Inc. · Devices · 2025-04-08
  Class II
• Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: Th

  THOR Photomedicine Ltd · Devices · 2025-07-24
  Class II
• Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER AC

  Sterilmed, Inc. · Devices · 2025-10-08
  Class II
• 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-10-06
  Class II
• Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel

  Remote Diagnostic Technologies Ltd. · Devices · 2025-11-26
  Class II
• Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4

  CareFusion 303, Inc. · Devices · 2025-05-08
  Class II
• Food Allergy Panel Test (IgE)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem

  Cardinal Health 200, LLC · Devices · 2025-09-18
  Class II
• Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectab

  Carefree Surgical Specialties · Devices · 2025-07-01
  Class II
• NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:

  Ferndale Laboratories, Inc. · Devices · 2025-11-25
  Class II
• Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

  Stryker Spine · Devices · 2025-02-28
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Paradigm insulin pump, REF: MMT-754

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

  Fresenius Kabi USA, LLC · Devices · 2025-06-24
  Class II
• Lago X

  Spectral Instruments Inc · Devices · 2025-05-13
  Class II
• GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

  Hologic, Inc · Devices · 2025-12-12
  Class II
• Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers o

  Diagnostica Stago, Inc. · Devices · 2025-07-21
  Class II
• Z1 Femoral Hip System, Product Number 611777612

  Zimmer, Inc. · Devices · 2025-02-12
  Class II
• Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

  Folsom Metal Products, Inc. · Devices · 2025-08-21
  Class II
• Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

  DJO, LLC · Devices · 2025-09-25
  Class II
• Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)

  Defibtech, LLC · Devices · 2025-03-18
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-1

  Encore Medical, LP · Devices · 2025-05-28
  Class II
• Change Healthcare Cardiology Hemo Software

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2025-05-22
  Class II
• Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

  AGFA Healthcare Corp. · Devices · 2025-11-18
  Class II
• AlluraXperFD20/15 System Code: (1) 722058

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2

  CareFusion 303, Inc. · Devices · 2025-01-08
  Class II
• Intera 3.0T Quasar Dual, Model Number: 781150;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• ARTIS One Angiographic X-Ray System

  SIEMENS MEDICAL SOLUTIONS USA, INC · Devices · 2025-01-02
  Class II
• FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

  BioFire Diagnostics, LLC · Devices · 2025-02-27
  Class II
• Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8

  Volcano Corp · Devices · 2025-06-13
  Class II
• Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4.

  Boston Scientific Corporation · Devices · 2025-08-05
  Class II
• KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

  Microbiologics Inc · Devices · 2025-12-02
  Class II
• CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

  Smiths Medical ASD, Inc. · Devices · 2025-02-14
  Class II
• Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

  CareFusion 303, Inc. · Devices · 2025-09-30
  Class II
• Food Intolerance Test Large

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

  Fisher Diagnostics · Devices · 2025-03-06
  Class II
• VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

  Canon Medical System, USA, INC. · Devices · 2025-12-19
  Class II
• ICU Medical ChemoLock Closed Vial Spike REF: CL-80

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOG

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• AV FISTULA , Model No UTAV77T

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• NAD Profile Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Vitamin D2 and D3 Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

  MicroSurgical Technology Inc · Devices · 2025-08-20
  Class II
• Intera 1.5T Power/Pulsar, Model Number: 781105;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

  Beckman Coulter Inc. · Devices · 2025-01-02
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v

  Abbott Laboratories · Devices · 2025-03-18
  Class II
• Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

  Terumo Cardiovascular Systems Corporation · Devices · 2025-03-03
  Class II
• Allura Xper FD20/10; Model Number: 722029;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• interventional fluoroscopic x-ray system

  Siemens Medical Solutions USA, Inc · Devices · 2025-05-15
  Class II
• MAJOR THORACOSCOPY BASIN. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Pr

  Encore Medical, LP · Devices · 2025-07-18
  Class II
• Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No

  Tecfen Medical · Devices · 2025-04-25
  Class II
• Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

  Fresenius Kabi USA, LLC · Devices · 2025-09-03
  Class II
• Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-08-01
  Class II
• LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-05
  Class II
• 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focu

  B-K Medical A/S · Devices · 2025-10-09
  Class II
• Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1

  Philips North America · Devices · 2025-12-03
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medl

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELV

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Versio

  Guangzhou Pluslife Biotech Co., Ltd. · Devices · 2025-01-24
  Class II
• Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

  Merit Medical Systems, Inc. · Devices · 2025-06-05
  Class II
• ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthet

  Hiossen Inc. · Devices · 2025-01-27
  Class II
• Material Processing Laser Products

  SHENZHEN ATOMSTACK TECHNOLOGIES · Devices · 2025-09-30
  Class II
• FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

  Inpeco S.A. · Devices · 2025-09-03
  Class II
• Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

  BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. · Devices · 2025-01-10
  Class II
• Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

  Stryker GmbH · Devices · 2025-05-28
  Class II
• InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001

  Enterix, Inc. · Devices · 2025-09-17
  Class II
• BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

  Copan Italia · Devices · 2025-05-02
  Class II
• ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Leaky Gut Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Kidney Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• ProxiDiagnost N90; Model Number: 706110;

  Philips Medical Systems DMC GmbH · Devices · 2025-10-01
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-06-30
  Class II
• 2 in 1 Trichomonas / Gardnerella Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

  Medica Corporation · Devices · 2025-12-31
  Class II
• Azurion 5 M12 System Code: (1) 722227 (2) 722231

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silico

  DSAART LLC · Devices · 2025-09-26
  Class II
• Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product De

  THOR Photomedicine Ltd · Devices · 2025-07-24
  Class II
• Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.

  Abbott Laboratories · Devices · 2025-09-18
  Class II
• Menopause (FSH) 2 Tests

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm

  Mozarc Medical US LLC · Devices · 2025-10-17
  Class II
• Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Appli

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

  Fisher & Paykel Healthcare, Ltd. · Devices · 2025-09-18
  Class II
• ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

  Microbiologics Inc · Devices · 2025-12-02
  Class II
• MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA5

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-05
  Class II
• Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content,

  CooperVision, Inc. · Devices · 2025-08-22
  Class II
• HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibr

  HeartSine Technologies Ltd · Devices · 2025-06-30
  Class II
• DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part

  Beckman Coulter Inc. · Devices · 2025-08-04
  Class II
• Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Blood Type Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-05-23
  Class II
• Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prostheti

  Hiossen Inc. · Devices · 2025-01-27
  Class II
• THORACIC PACK , Model No UTTC82Y UTTC82AA-01

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• interventional fluoroscopic x-ray system

  Siemens Medical Solutions USA, Inc · Devices · 2025-05-15
  Class II
• Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

  ICU Medical, Inc. · Devices · 2025-12-15
  Class II
• SMV DSI, System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-12-10
  Class II
• Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• 3 in 1 STI Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERIL

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac

  Cook Incorporated · Devices · 2025-11-26
  Class II
• Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The N

  THOR Photomedicine Ltd · Devices · 2025-07-24
  Class II
• Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

  Altruan GmbH · Devices · 2025-12-19
  Class II
• UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

  Beckman Coulter Inc. · Devices · 2025-08-13
  Class II
• Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-12
  Class II
• ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-03-11
  Class II
• Premier Solo Diamond - Large Invented Cone; SKU: 807016C.

  Premier Dental Products Co · Devices · 2025-02-27
  Class II
• MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS86001

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa

  GE Healthcare Finland Oy · Devices · 2025-09-26
  Class II
• ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt

  FUJIFILM Healthcare Americas Corporation · Devices · 2025-06-11
  Class II
• Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• IntelliVue MP60. Product Number: M8005A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01

  CareFusion 303, Inc. · Devices · 2025-03-11
  Class II
• Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-04-03
  Class II
• ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Produc

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinter

  Iantrek Inc. · Devices · 2025-09-06
  Class II
• Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

  Fresenius Kabi USA, LLC · Devices · 2025-11-21
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002

  Reflexion Medical, Inc. · Devices · 2025-07-22
  Class II
• Model Number 40KWFXPLUS.002, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000

  Physio-Control, Inc. · Devices · 2025-07-22
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

  Philips North America · Devices · 2025-06-30
  Class II
• Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca

  Merit Medical Systems, Inc. · Devices · 2025-03-14
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Pa

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho

  Onkos Surgical, Inc. · Devices · 2025-05-20
  Class II
• Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Las

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

  B-K Medical A/S · Devices · 2025-10-09
  Class II
• Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD J

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIK

  S.I.N. Implant System Ltda · Devices · 2025-07-30
  Class II
• AlternatiV+ Max Knotless Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

  GE Medical Systems, LLC · Devices · 2025-09-18
  Class II
• Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

  Abbott · Devices · 2025-03-17
  Class II
• Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall S

  Cardinal Health 200, LLC · Devices · 2025-05-13
  Class II
• DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-

  Nuclein LLC · Devices · 2025-06-25
  Class II
• RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStati

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso

  Intuitive Surgical, Inc. · Devices · 2025-12-09
  Class II
• MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin p

  Medtronic MiniMed, Inc. · Devices · 2025-11-02
  Class II
• Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (

  C-RAD POSITIONING AB · Devices · 2025-04-22
  Class II
• Biological Age & Longevity Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /

  Merit Medical Systems, Inc. · Devices · 2025-07-25
  Class II
• HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The M

  Merge Healthcare, Inc. · Devices · 2025-08-11
  Class II
• Washer Disinfector Aquadis 56; Model Number: 56A

  Getinge Disinfection Ab · Devices · 2025-04-02
  Class II
• Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-10-06
  Class II
• Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310

  Encore Medical, LP · Devices · 2025-07-18
  Class II
• Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model

  Checkpoint Surgical Inc · Devices · 2025-02-24
  Class II
• S. Typhi/Para Typhi A Antigen

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX

  Radiometer Medical ApS · Devices · 2025-03-21
  Class II
• NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

  Preat Corp · Devices · 2025-06-25
  Class II
• Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 4019

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-06
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic a

  Pentax of America Inc · Devices · 2025-01-29
  Class II
• BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro d

  Becton Dickinson & Co. · Devices · 2025-09-23
  Class II
• Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr

  Zimmer, Inc. · Devices · 2025-03-24
  Class II
• Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E EN

  Cardinal Health 200, LLC · Devices · 2025-09-18
  Class II
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

  Beckman Coulter, Inc. · Devices · 2025-02-06
  Class II
• Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used i

  Preat Corp · Devices · 2025-04-02
  Class II
• Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.

  Stryker GmbH · Devices · 2025-05-22
  Class II
• Lyme Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall

  Cardinal Health 200, LLC · Devices · 2025-05-13
  Class II
• Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

  Mobius Imaging, LLC · Devices · 2025-12-04
  Class II
• Drug Test Small (4 substances)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-00

  GE Healthcare · Devices · 2025-02-19
  Class II
• Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

  Inpeco S.A. · Devices · 2025-09-03
  Class II
• Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

  Philips North America · Devices · 2025-06-30
  Class II
• Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

  Cepheid · Devices · 2025-10-30
  Class II
• Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

  Bard Peripheral Vascular Inc · Devices · 2025-11-06
  Class II
• Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

  Baxter Healthcare Corporation · Devices · 2025-03-03
  Class II
• RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• IntelliVue MP5. Product Number: M8105A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

  Folsom Metal Products, Inc. · Devices · 2025-08-21
  Class II
• Organic acids Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

  Jewel Precision Sheet Metal & Machining Co, Inc. · Devices · 2025-05-22
  Class II
• BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF

  CareFusion 303, Inc. · Devices · 2025-02-06
  Class II
• Access 2 Immunoassay Analyzer, Catalog Number 81600N

  Beckman Coulter, Inc. · Devices · 2025-02-05
  Class II
• HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.

  Hardy Diagnostics · Devices · 2025-05-06
  Class II
• ICU Medical Plum Solos, Item number 400011001; infusion pump

  ICU Medical, Inc. · Devices · 2025-04-22
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Zimmer Dermatome AN, Model/Catalog Number: 88710100

  Zimmer Surgical Inc · Devices · 2025-11-24
  Class II
• Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corre

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-08-01
  Class II
• ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative i

  Bio-Rad Laboratories, Inc. · Devices · 2025-05-30
  Class II
• Intera 1.5T R11, Model Number: 781170;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• IntelliVue MP20. Product Number: M8001A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1

  DSAART LLC · Devices · 2025-09-26
  Class II
• Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

  OSSTEM Implant Co., Ltd. · Devices · 2025-08-26
  Class II
• Allon 2001. Part Number: 200-00263

  Belmont Instrument LLC · Devices · 2025-05-13
  Class II
• CombiDiagnost R90; Model Number: 709031;

  Philips Medical Systems DMC GmbH · Devices · 2025-10-01
  Class II
• Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326

  Philips North America Llc · Devices · 2025-08-13
  Class II
• Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Ster

  Sheathing Technologies Inc · Devices · 2025-11-17
  Class II
• Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

  Boston Scientific Corporation · Devices · 2025-08-28
  Class II
• Intera 3.0T Quasar Dual Model Number (REF): 781150;

  Philips North America · Devices · 2025-06-30
  Class II
• Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuratio

  BIGFOOT BIOMEDICAL · Devices · 2025-05-21
  Class II
• Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• O-arm O2 Imaging System. Mobile X-Ray System.

  Medtronic Navigation, Inc.-Boxborough · Devices · 2025-05-27
  Class II
• Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile

  Micro-X Ltd. · Devices · 2025-03-28
  Class II
• Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

  GE Medical Systems, LLC · Devices · 2025-10-24
  Class II
• Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

  Telcare, LLC · Devices · 2025-01-30
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

  Beckman Coulter, Inc. · Devices · 2025-04-23
  Class II
• Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile

  Micro-X Ltd. · Devices · 2025-03-28
  Class II
• Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Descriptio

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Vers

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

  Globus Medical, Inc. · Devices · 2025-04-03
  Class II
• Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

  Greiner Bio-One North America, Inc. · Devices · 2025-08-08
  Class II
• Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Des

  Spacelabs Healthcare, Ltd. · Devices · 2025-09-16
  Class II
• OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number:

  Becton Dickinson & Co. · Devices · 2025-09-23
  Class II
• TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

  Tornier, Inc · Devices · 2025-12-19
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M00671

  Boston Scientific Corporation · Devices · 2025-08-05
  Class II
• Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Versio

  Qiagen Sciences LLC · Devices · 2025-03-12
  Class II
• Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software v

  Abbott Laboratories · Devices · 2025-03-18
  Class II
• MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS7801

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Vers

  MicroPort Orthopedics Inc. · Devices · 2025-12-19
  Class II
• Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and

  BD SWITZERLAND SARL · Devices · 2025-02-20
  Class II
• Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

  Stryker GmbH · Devices · 2025-03-28
  Class II
• Hair Mineral Analysis

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Pro

  Rocket Medical Plc · Devices · 2025-11-07
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• IntelliVue Patient Monitor MX600. Product Number: 865242.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

  Merit Medical Systems, Inc. · Devices · 2025-06-05
  Class II
• UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• Gut Microbiome Test Large

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00

  BALT USA, LLC · Devices · 2025-05-08
  Class II
• MONARCH Bronchoscope. Model Number: MBR-000211-B

  Auris Health, Inc · Devices · 2025-10-18
  Class II
• Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catal

  Encore Medical, LP · Devices · 2025-06-12
  Class II
• REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence com

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2025-06-03
  Class II
• MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24

  Mozarc Medical US LLC · Devices · 2025-10-17
  Class II
• Chlamydia Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Allura Xper FD10; Model Number: 722010;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tub

  Applied Medical Technology Inc · Devices · 2025-08-12
  Class II
• Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

  Philips North America · Devices · 2025-06-30
  Class II
• BD COR System Software. Model Number: 444829.

  Becton Dickinson & Co. · Devices · 2025-06-23
  Class II
• Portex Spinal Tray, Item No. A3729-24 A3595

  ICU Medical Inc. · Devices · 2025-12-19
  Class II
• Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operatio

  Belmont Instrument LLC · Devices · 2025-01-02
  Class II
• Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers ar

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify

  Insulet Corporation · Devices · 2025-09-11
  Class II
• Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product

  Olympus Corporation of the Americas · Devices · 2025-10-14
  Class II
• Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1

  CooperVision, Inc. · Devices · 2025-02-27
  Class II
• Intera 1.5T Achieva Nova Product Number: 781172;

  Philips North America · Devices · 2025-05-29
  Class II
• HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5

  Illumina, Inc. · Devices · 2025-10-28
  Class II
• Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

  FUJIFILM Healthcare Americas Corporation · Devices · 2025-02-11
  Class II
• Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

  Medicrea International · Devices · 2025-10-29
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIO

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Laser light show projectors manufactured by BLS, Model PURE 5000/10000.

  Beyond Laser Systems, LLC · Devices · 2025-06-30
  Class II
• Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult

  Jolife AB · Devices · 2025-05-21
  Class II
• FlexLab (FLX); Version: FLX-217-40;

  Inpeco S.A. · Devices · 2025-10-30
  Class II
• TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s

  Sysmex America, Inc. · Devices · 2025-12-15
  Class II
• Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Gonorrhea test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 3162

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

  Limacorporate S.p.A · Devices · 2025-05-19
  Class II
• CV BASIC PUMP PACK , Model No WECV23D

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tes

  Cepheid · Devices · 2025-08-06
  Class II
• Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Portable X-ray system

  DIGIMED CO., LTD · Devices · 2025-06-19
  Class II
• Genesis Dual Thread Screw-In Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TIS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backche

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-06-04
  Class II
• GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Philips VL13-5 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Naviga

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2025-11-17
  Class II
• Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Allwell Angioplasty Pack REF: IS-30-B1/B

  Merit Medical Systems, Inc. · Devices · 2025-12-04
  Class II
• IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

  Angiodynamics, Inc. · Devices · 2025-02-04
  Class II
• Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

  Intersurgical Inc · Devices · 2025-06-20
  Class II
• SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging proc

  Surgical Theater Inc · Devices · 2025-09-16
  Class II
• Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

  Medtronic Neuromodulation · Devices · 2025-01-09
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, M

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

  Intuitive Surgical, Inc. · Devices · 2025-11-17
  Class II
• Cholesterol Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-19
  Class II
• Iron Deficiency Test (ferritin)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS i

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Mode

  Checkpoint Surgical Inc · Devices · 2025-02-24
  Class II
• Welch Allyn CP150 Electrocardiograph:

  Baxter Healthcare Corporation · Devices · 2025-03-24
  Class II
• Allura Xper FD20/20 System Code: (1) 722038

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc

  Abbott Diagnostics Scarborough, Inc. · Devices · 2025-03-04
  Class II
• 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 13

  CareFusion 303, Inc. · Devices · 2025-01-08
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Refer to RES

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Stryker Arise 1000EX mattress, Part Number 2236000000

  Stryker Medical Division of Stryker Corporation · Devices · 2025-10-31
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen

  Cardinal Health 200, LLC · Devices · 2025-05-02
  Class II
• 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Medical convenience kits UDPG88W PICC G-TUBE PACK-230209

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

  Beckman Coulter Inc. · Devices · 2025-09-03
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-07-15
  Class II
• Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Thyroid TSH Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Model Number 40KWFXPLUS-710CW, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

  Diasol, Inc · Devices · 2025-11-05
  Class II
• Tecfen Retractable Membrane Polisher, QTPR1267-23

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

  Philips North America · Devices · 2025-06-30
  Class II
• Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-06-20
  Class II
• ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Intera Achieva 1.5T Pulsar; Product Number: 781171;

  Philips North America · Devices · 2025-05-29
  Class II
• Molding Equipment. WCM series. Model WCM-330GL-i

  Apic Yamada America · Devices · 2025-04-07
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Patient Information Center iX; Software Version Number: 4.5.0

  Philips North America · Devices · 2025-12-22
  Class II
• MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system

  GE Medical Systems Information Technologies Inc · Devices · 2025-04-25
  Class II
• SIGNA PET/MR

  GE Medical Systems, LLC · Devices · 2025-05-23
  Class II
• GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4)

  GE Healthcare · Devices · 2025-02-19
  Class II
• Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl

  Bard Peripheral Vascular Inc · Devices · 2025-08-21
  Class II
• Stryker MV3 bariatric bed, Part Number 5900000001

  Stryker Medical Division of Stryker Corporation · Devices · 2025-10-31
  Class II
• Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, He

  Thoratec LLC · Devices · 2025-10-09
  Class II
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

  ICU Medical, Inc. · Devices · 2025-05-02
  Class II
• Herpes (HSV-1 & HSV-2) Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• COR Disposable Kit, 8 mm. Cartilage Transplant System.

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2025-02-24
  Class II
• 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2H

  CareFusion 303, Inc. · Devices · 2025-01-08
  Class II
• Baxter Stationary column TruSystem 7500 U, Product Code 1730731

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• HVI CARDIAC ROBOT PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

  CooperSurgical, Inc. · Devices · 2025-06-11
  Class II
• UROSKOP Omnia. Model Number: 10094910

  Siemens Medical Solutions USA, Inc · Devices · 2025-06-04
  Class II
• Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transderm

  LTS Therapy Systems, LLC · Devices · 2025-05-22
  Class II
• Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

  Siemens Healthcare Diagnostics Inc · Devices · 2025-03-31
  Class II
• Intera 1.5T, Model Numbers: 781195 and 781295;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spa

  GE Healthcare Finland Oy · Devices · 2025-09-26
  Class II
• Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Intera 1.0T Power/Pulsar, Model Number: 781103;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Softwa

  Tecfen Medical · Devices · 2025-04-25
  Class II
• Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CO

  GOLD STAR DISTRIBUTION INC · Devices · 2025-12-26
  Class II
• Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-0

  Spacelabs Healthcare, Inc. · Devices · 2025-09-05
  Class II
• Iron Deficiency Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51

  BioPro, Inc. · Devices · 2025-09-09
  Class II
• MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm

  Mozarc Medical US LLC · Devices · 2025-10-17
  Class II
• Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

  Steris Corporation · Devices · 2025-05-23
  Class II
• Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone se

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

  Stryker Corporation · Devices · 2025-02-25
  Class II
• Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2M

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• Allura Xper FD20 Biplane; Model Number: 722008;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes M

  Olympus Corporation of the Americas · Devices · 2025-11-14
  Class II
• Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Softwar

  Heraeus Medical GmbH (Dental Division) · Devices · 2025-12-09
  Class II
• TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

  Straumann USA LLC · Devices · 2025-03-08
  Class II
• GM Helix Acqua Implant, Article Number: 140.984

  Straumann USA LLC · Devices · 2025-05-01
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• GENERAL ROBOTIC PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF

  NxStage Medical Inc · Devices · 2025-04-28
  Class II
• Artegraft¿ Collagen Vascular Graft; REF: AG1015;

  LeMaitre Vascular, Inc. · Devices · 2025-09-25
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 P

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• Intera 1.5T Master/Nova Product Number: 781106;

  Philips North America · Devices · 2025-05-29
  Class II
• Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Diabetes Test (ketones & glucose)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DR

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

  LimFlow, Inc. · Devices · 2025-12-05
  Class II
• REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 m

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-05-21
  Class II
• Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BA

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description

  Sonesta Medical AB · Devices · 2025-08-22
  Class II
• OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incis

  LUMENIS, LTD. · Devices · 2025-07-22
  Class II
• bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

  B-K Medical A/S · Devices · 2025-10-09
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 0084126810480

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered com

  Ithera Medical Gmbh · Devices · 2025-01-08
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

  Stryker GmbH · Devices · 2025-03-28
  Class II
• Vivoo pH Test

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEM

  BioPro, Inc. · Devices · 2025-09-09
  Class II
• DEXLOCK Achilles Repair Implant Kits, MAKT4520

  Medline Industries, LP · Devices · 2025-11-11
  Class II
• GM85 Digital Mobile X-ray imaging System; Model Number: GM85;

  NeuroLogica Corporation · Devices · 2025-10-07
  Class II
• Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring o

  Instrumentation Laboratory · Devices · 2025-12-11
  Class II
• Liver Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagno

  Civco Medical Instruments Co. Inc. · Devices · 2025-05-01
  Class II
• XERF EFFECTOR 60. Electrosurgical unit.

  Lutronic Corporation · Devices · 2025-09-04
  Class II
• Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251

  SUMMA THERAPEUTICS, LLC · Devices · 2025-07-21
  Class II
• BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis use

  CareFusion 303, Inc. · Devices · 2025-01-10
  Class II
• Bodor's I series laser cutting machine.

  Jinan Bodor Cnc Machine Co Ltd · Devices · 2025-02-07
  Class II
• NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14

  Zimmer, Inc. · Devices · 2025-01-06
  Class II
• SED URS LP, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation

  Tyber Medical · Devices · 2025-01-21
  Class II
• InPen App, Model/CFN Number: MMT-8061 (Android Users)

  Medtronic MiniMed, Inc. · Devices · 2025-11-13
  Class II
• stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Se

  Tornier, Inc · Devices · 2025-03-03
  Class II
• Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catal

  Encore Medical, LP · Devices · 2025-06-12
  Class II
• Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22

  Defibtech, LLC · Devices · 2025-03-18
  Class II
• Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.

  AVID Medical, Inc. · Devices · 2025-03-31
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No

  Tecfen Medical · Devices · 2025-04-25
  Class II
• Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.

  Stryker Spine · Devices · 2025-02-28
  Class II
• Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-02-14
  Class II
• IntelliVue Patient Monitor MX400. Product Number: 866060.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in str

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterog

  CooperSurgical, Inc. · Devices · 2025-06-11
  Class II
• . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP

  Nobel Biocare · Devices · 2025-01-10
  Class II
• IntelePACS - InteleConnect / TechPortal

  INTELERAD MEDICAL SYSTEMS INCORPORATED · Devices · 2025-10-17
  Class II
• Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Philips L8-4 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

  PREMIA SPINE LTD · Devices · 2025-07-16
  Class II
• Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product

  Elekta, Inc. · Devices · 2025-12-12
  Class II
• stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Real

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:

  Orthofix U.S. LLC · Devices · 2025-09-19
  Class II
• IntelePACS (Image Fusion Module) - InteleViewer

  INTELERAD MEDICAL SYSTEMS INCORPORATED · Devices · 2025-02-05
  Class II
• Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Graspe

  Intuitive Surgical, Inc. · Devices · 2025-12-09
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-05-28
  Class II
• 25GA Subretinal Injection Cannula VS0220.25

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOP

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.

  Intersurgical Inc · Devices · 2025-06-20
  Class II
• Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Folsom Metal Products, Inc. · Devices · 2025-08-21
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)

  Maquet Cardiovascular, LLC · Devices · 2025-03-10
  Class II
• Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X

  Micro-X Ltd. · Devices · 2025-04-04
  Class II
• Pregnancy Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000

  Medline Industries, LP · Devices · 2025-11-13
  Class II
• 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

  Copan Italia · Devices · 2025-10-29
  Class II
• Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

  Cardinal Health 200, LLC · Devices · 2025-05-02
  Class II
• Allergy & Food Intolerance Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and i

  Scientia Vascular, Inc. · Devices · 2025-01-16
  Class II
• Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

  Maquet Cardiopulmonary Gmbh · Devices · 2025-06-27
  Class II
• MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulm

  Spectrum Medical Inc · Devices · 2025-01-16
  Class II
• Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

  B Braun Medical Inc · Devices · 2025-02-17
  Class II
• CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre

  Thoratec LLC · Devices · 2025-10-10
  Class II
• Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;

  Philips North America · Devices · 2025-06-30
  Class II
• Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASI

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compo

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-11-10
  Class II
• Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-03-24
  Class II
• CellMek SPS Sample Preparation System, REF: C44603, with software

  Beckman Coulter, Inc. · Devices · 2025-12-23
  Class II
• Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga.

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

  Philips North America Llc · Devices · 2025-03-10
  Class II
• Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Appli

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDI

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

  LeMaitre Vascular, Inc. · Devices · 2025-04-11
  Class II
• Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Plum Duo Infusion System, List Number 40002-04-01

  ICU Medical, Inc. · Devices · 2025-12-15
  Class II
• LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-07-31
  Class II
• IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal pa

  LTS Therapy Systems, LLC · Devices · 2025-05-22
  Class II
• CARDIAC ROBOT PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941

  Covidien · Devices · 2025-06-23
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, effici

  Trimble Ab · Devices · 2025-03-26
  Class II
• Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ4411

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el

  Roche Diagnostics Operations, Inc. · Devices · 2025-11-21
  Class II
• TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1

  LeMaitre Vascular, Inc. · Devices · 2025-04-11
  Class II
• Ovulation Test (5 tests)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China

  Vantive US Healthcare LLC · Devices · 2025-08-28
  Class II
• DAVINCI UROLOGY. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-12
  Class II
• 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3)

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• Baxter Operating table column TS7500 MOBIUS, Product Code 1704695

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Orascoptic Superior Visualization Custom loupes with Dragonfly frames

  Orascoptic Surgical Acuity · Devices · 2025-07-03
  Class II
• Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

  Preat Corp · Devices · 2025-06-24
  Class II
• FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048

  Medline Industries, LP · Devices · 2025-11-13
  Class II
• Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6

  Vascutek, Ltd. · Devices · 2025-12-18
  Class II
• BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316

  C.R. Bard Inc · Devices · 2025-06-03
  Class II
• GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with th

  Belmont Instrument LLC · Devices · 2025-03-31
  Class II
• LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

  Microbiologics Inc · Devices · 2025-06-27
  Class II
• CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

  Fresenius Kabi USA, LLC · Devices · 2025-06-24
  Class II
• ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-06-10
  Class II
• Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia D

  Spectrum Medical Ltd. · Devices · 2025-03-19
  Class II
• Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B;

  Baxter Healthcare Corporation · Devices · 2025-03-21
  Class II
• Alphenix INFX-8000H, interventional fluoroscopic x-ray system

  Canon Medical System, USA, INC. · Devices · 2025-12-19
  Class II
• Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Ve

  Exactech, Inc. · Devices · 2025-09-05
  Class II
• Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073

  Medtronic Sofamor Danek USA Inc · Devices · 2025-09-16
  Class II
• BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

  BioFire Diagnostics, LLC · Devices · 2025-10-22
  Class II
• NEURO IR TRAY , Model No WENI56J

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216

  C.R. Bard Inc · Devices · 2025-07-17
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

  Alcon Research LLC · Devices · 2025-08-05
  Class II
• Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

  AVID Medical, Inc. · Devices · 2025-08-04
  Class II
• Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.1

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060

  Medtronic Inc · Devices · 2025-12-04
  Class II
• Intelerad InteleShare software, with ProViewer component

  DICOM Grid, Inc. · Devices · 2025-11-18
  Class II
• Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Ve

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-29
  Class II
• BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Rep

  Biomet, Inc. · Devices · 2025-09-23
  Class II
• IntelliVue Multi-Measurement Module X3. Product Number: 867030.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X;

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• LOGIQ P10 series with software version R4.5.7 Model Number 5877534

  GE Medical Systems, LLC · Devices · 2025-09-18
  Class II
• ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

  Onkos Surgical, Inc. · Devices · 2025-07-11
  Class II
• MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mo

  CooperVision, Inc. · Devices · 2025-08-22
  Class II
• Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobil

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rov

  Micro-X Ltd. · Devices · 2025-04-04
  Class II
• Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF

  C.R. Bard Inc · Devices · 2025-06-18
  Class II
• STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/

  ETHICON, LLC · Devices · 2025-08-15
  Class II
• Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suc

  Scientia Vascular, Inc. · Devices · 2025-01-02
  Class II
• Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Who

  Accriva Diagnostics, Inc. · Devices · 2025-11-05
  Class II
• Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog N

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-09-22
  Class II
• GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PAC

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

  Johnson & Johnson Vision Care, Inc. · Devices · 2025-06-12
  Class II
• MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3

  ELEKTA SOLUTIONS AB · Devices · 2025-09-17
  Class II
• Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Produ

  Elekta, Inc. · Devices · 2025-09-30
  Class II
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

  Beckman Coulter, Inc. · Devices · 2025-02-05
  Class II
• Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

  Abiomed, Inc. · Devices · 2025-12-04
  Class II
• Food Sensitivity Test Medium

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

  Microbiologics Inc · Devices · 2025-06-17
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYS

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Nu

  Alcon Research LLC · Devices · 2025-04-28
  Class II
• Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C.

  Olympus Corporation of the Americas · Devices · 2025-07-25
  Class II
• Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFL

  Fresenius Medical Care Holdings, Inc. · Devices · 2025-08-29
  Class II
• Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

  Cardinal Health 200, LLC · Devices · 2025-05-02
  Class II
• ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PAC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover

  Aesculap Inc · Devices · 2025-01-31
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3

  Stryker Corporation · Devices · 2025-07-02
  Class II
• BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

  Becton Dickinson & Co. · Devices · 2025-10-23
  Class II
• MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• GS ENDOSCOPY PACK. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, La

  LUMENIS, LTD. · Devices · 2025-01-23
  Class II
• Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H

  Boston Scientific Corporation · Devices · 2025-12-03
  Class II
• Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

  Healthmark Industries Co., Inc. · Devices · 2025-05-02
  Class II
• Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WH

  Medline Industries, LP · Devices · 2025-12-16
  Class II
• GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• PREGNANCY TEST 24CT

  GOLD STAR DISTRIBUTION INC · Devices · 2025-12-26
  Class II
• ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i

  Beckman Coulter, Inc. · Devices · 2025-09-19
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Alphenix INFX-8000V, interventional fluoroscopic x-ray system

  Canon Medical System, USA, INC. · Devices · 2025-12-19
  Class II
• Olympus OER-Pro

  Aizu Olympus Co., Ltd. · Devices · 2025-10-31
  Class II
• Model Number 40KWFXPLUS, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3)

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2025-04-03
  Class II
• Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

  Cardinal Health 200, LLC · Devices · 2025-05-02
  Class II
• Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitat

  Beckman Coulter Ireland, Inc. · Devices · 2025-10-14
  Class II
• Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans

  Cook Incorporated · Devices · 2025-11-26
  Class II
• LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Ret

  Synthes (USA) Products LLC · Devices · 2025-09-26
  Class II
• BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-

  CareFusion 303, Inc. · Devices · 2025-03-11
  Class II
• Intera CV, Model Number: 781107;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-03-24
  Class II
• MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.

  Medline Industries, LP · Devices · 2025-10-03
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2025-04-21
  Class II
• Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001

  Dexcom, Inc. · Devices · 2025-01-27
  Class II
• Discovery MR750w 3.0T

  GE Medical Systems, LLC · Devices · 2025-05-23
  Class II
• Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Biofinity Toric Multifocal Contact Lens

  CooperVision, Inc. · Devices · 2025-06-16
  Class II
• Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant sty

  DSAART LLC · Devices · 2025-09-26
  Class II
• DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud

  ConvaTec, Inc · Devices · 2025-08-29
  Class II
• DxI 9000 Access Immunoassay Analyzer C11137

  Beckman Coulter, Inc. · Devices · 2025-05-07
  Class II
• ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

  Diasol, Inc · Devices · 2025-11-05
  Class II
• Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR

  Sterilmed, Inc. · Devices · 2025-10-08
  Class II
• Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PRO

  Medline Industries, LP · Devices · 2025-12-16
  Class II
• Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal

  Olympus Corporation of the Americas · Devices · 2025-10-06
  Class II
• Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

  Mozarc Medical US LLC · Devices · 2025-04-23
  Class II
• Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

  Philips North America Llc · Devices · 2025-08-13
  Class II
• (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta

  CareFusion 303, Inc. · Devices · 2025-01-08
  Class II
• Intera 1.5T Omni/Stellar; Product Number: 781104;

  Philips North America · Devices · 2025-05-29
  Class II
• Men s Hormone Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fra

  Tyber Medical · Devices · 2025-01-21
  Class II
• stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Genesis Screw-In Anchor

  Aju Pharm Co., Ltd. · Devices · 2025-12-17
  Class II
• SMV BodyTrack, System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-12-10
  Class II
• Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMA

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guid

  Augmedics Ltd. · Devices · 2025-04-14
  Class II
• EAR PACK , Model No SFEA12A

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-07-29
  Class II
• ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

  Philips North America · Devices · 2025-12-03
  Class II
• Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

  Ambu Inc. · Devices · 2025-04-07
  Class II
• Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE

  Exactech, Inc. · Devices · 2025-08-15
  Class II
• ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Devices · 2025-10-16
  Class II
• stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

  Stryker Corporation · Devices · 2025-01-08
  Class II
• GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• FlexLab (FLX); Version: FLX-217-10;

  Inpeco S.A. · Devices · 2025-10-30
  Class II
• OEC 3D

  GE Medical Systems, LLC · Devices · 2025-03-21
  Class II
• Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applicatio

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638,

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Num

  Olympus Corporation of the Americas · Devices · 2025-05-06
  Class II
• Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Descr

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA

  LivaNova USA, Inc. · Devices · 2025-01-03
  Class II
• Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146

  Philips North America Llc · Devices · 2025-05-13
  Class II
• H pylori (Peptic ulcer) Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-06-16
  Class II
• MAMMOMAT Revelation;

  Siemens Medical Solutions USA, Inc · Devices · 2025-10-24
  Class II
• SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

  Philips North America Llc · Devices · 2025-12-12
  Class II
• ChemoLock Bag Spike, 01 units REF: CL-10-10

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version

  Abbott Diagnostics Scarborough, Inc. · Devices · 2025-03-04
  Class II
• Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.

  Maquet Cardiovascular, LLC · Devices · 2025-08-15
  Class II
• HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Ra

  Leica Biosystems Melbourne Pty Ltd · Devices · 2025-04-02
  Class II
• Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70

  Channel Medsystems, Inc. · Devices · 2025-03-20
  Class II
• Discovery XR656HD. X-Ray imaging system.

  GE Medical Systems, LLC · Devices · 2025-01-28
  Class II
• Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-05
  Class II
• MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ653

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• IntelliVue Patient Monitor MX550. Product Number: 866066.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

  Nipro Medical Corporation · Devices · 2025-10-27
  Class II
• Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OC

  Microgenics Corporation · Devices · 2025-10-01
  Class II
• Neurotransmitters Basic

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Access Testosterone assay, Catalog Number 33560

  Beckman Coulter, Inc. · Devices · 2025-05-05
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

  Altruan GmbH · Devices · 2025-12-19
  Class II
• LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3)

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• LH One Step Ovulation Test Device (Urine)

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, EC

  W L Gore & Associates, Inc. · Devices · 2025-08-26
  Class II
• Monterey AL Implant Inserter; 22mm; Catalog 48019140.

  Stryker Spine · Devices · 2025-02-28
  Class II
• Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Mo

  Tyber Medical · Devices · 2025-12-19
  Class II
• Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 38

  Contract Medical International GmbH · Devices · 2025-07-30
  Class II
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 me

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• SIGNA MR380, NMRI system, Non-US Only

  GE Healthcare (China) Co., Ltd. · Devices · 2025-01-31
  Class II
• Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A

  American Contract Systems, Inc. · Devices · 2025-01-31
  Class II
• LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 119

  Physio-Control, Inc. · Devices · 2025-01-21
  Class II
• Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Si

  Neurovision Medical Products Inc · Devices · 2025-05-19
  Class II
• LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

  Fresenius Kabi USA, LLC · Devices · 2025-06-24
  Class II
• Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product De

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-08-05
  Class II
• Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLAST

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Mode

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Fecal Occult Blood Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• IntelliVue Patient Monitor MX750. Product Number: 866471.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained

  Zimmer, Inc. · Devices · 2025-03-24
  Class II
• Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Mode

  Intuitive Surgical, Inc. · Devices · 2025-12-09
  Class II
• SMV DSX New Line, System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-12-10
  Class II
• Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style

  DSAART LLC · Devices · 2025-09-26
  Class II
• Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• IntelliBridge EC10 Module. Model Number: 865115

  Philips North America Llc · Devices · 2025-01-15
  Class II
• GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations

  Galt Medical Corporation · Devices · 2025-03-27
  Class II
• Blood/EMB, Levine 100/PK, Product Number R02041

  Remel, Inc · Devices · 2025-07-11
  Class II
• ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-07-09
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLO

  UIH Technologies LLC · Devices · 2025-09-12
  Class II
• Women s Hormone Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version

  B.Braun Medical S.A.S. · Devices · 2025-07-21
  Class II
• Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description

  Centinel Spine, Inc. · Devices · 2025-12-31
  Class II
• Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or low

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

  Ethicon Endo Surgery, LLC · Devices · 2025-03-07
  Class II
• Melatonin Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

  Hologic, Inc · Devices · 2025-12-15
  Class II
• Medline Adult Anesthesia Set, REF DYNJ39985G

  Medline Industries, LP · Devices · 2025-09-10
  Class II
• ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention

  Siemens Medical Solutions USA, Inc · Devices · 2025-05-15
  Class II
• FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

  FUJIFILM Healthcare Americas Corporation · Devices · 2025-09-15
  Class II
• Olympus OER-Mini

  Aizu Olympus Co., Ltd. · Devices · 2025-10-31
  Class II
• ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filli

  Onkos Surgical, Inc. · Devices · 2025-07-11
  Class II
• COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2025-02-24
  Class II
• Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS

  Medline Industries, LP · Devices · 2025-10-27
  Class II
• Model Number 40KWFX, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT

  GOLD STAR DISTRIBUTION INC · Devices · 2025-12-26
  Class II
• DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C

  DeRoyal Industries Inc · Devices · 2025-01-31
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS,

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

  Beckman Coulter, Inc. · Devices · 2025-07-10
  Class II
• ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Plus Initial Drill, Article Number: 103.170;

  Straumann USA LLC · Devices · 2025-04-14
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP AC

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Allura Xper FD20 OR Table; Model Number: 722023;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Cardiac Workstation 7000; Model Number: 860441;

  Philips North America · Devices · 2025-09-12
  Class II
• IntelliVue Patient Monitor MX450. Product Number: 866062.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,

  Merit Medical Systems, Inc. · Devices · 2025-08-04
  Class II
• Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP

  Contego Medical LLC · Devices · 2025-09-04
  Class II
• Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

  Philips North America Llc · Devices · 2025-08-13
  Class II
• Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-05-09
  Class II
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer

  Beckman Coulter, Inc. · Devices · 2025-03-27
  Class II
• Neurotransmitters XL

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• GM Helix Acqua Implant, Article Number: 140.985

  Straumann USA LLC · Devices · 2025-05-01
  Class II
• Mazor X robotic guidance system REF: TPL0059

  Mazor Robotics Ltd · Devices · 2025-12-10
  Class II
• Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-10-02
  Class II
• Allura Xper FD20 Biplane; Model Number: 722013;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol f

  Beckman Coulter Ireland, Inc. · Devices · 2025-12-08
  Class II
• BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 END

  BioPro, Inc. · Devices · 2025-09-09
  Class II
• Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-08-11
  Class II
• IBS Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

  Physio-Control, Inc. · Devices · 2025-02-03
  Class II
• Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version

  C-RAD POSITIONING AB · Devices · 2025-10-09
  Class II
• Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

  Pivotal Health Solutions, Inc. · Devices · 2025-10-09
  Class II
• Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system

  GE Medical Systems, LLC · Devices · 2025-03-06
  Class II
• Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic

  ENDOMAGNETICS LTD · Devices · 2025-10-01
  Class II
• Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCN

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 153

  ETAC A/S · Devices · 2025-11-17
  Class II
• ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Sorbitol Intolerance Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

  Beckman Coulter, Inc. · Devices · 2025-10-01
  Class II
• Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No

  Tecfen Medical · Devices · 2025-04-25
  Class II
• ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

  ICU Medical, Inc. · Devices · 2025-09-08
  Class II
• Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

  Philips North America · Devices · 2025-06-30
  Class II
• VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-06-10
  Class II
• Product Name: Upgrade to MR 7700; Model Number: 782130;

  Philips North America Llc · Devices · 2025-05-13
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu

  Stryker Corporation · Devices · 2025-02-25
  Class II
• CT DAVINCI. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

  Onkos Surgical, Inc. · Devices · 2025-07-11
  Class II
• Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software

  Heraeus Medical GmbH (Dental Division) · Devices · 2025-12-09
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affecte

  Alcon Research LLC · Devices · 2025-04-28
  Class II
• Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device Kl

  Klinika Mdical Gmb · Devices · 2025-04-04
  Class II
• Optima MR360, NMRI system

  GE Healthcare (China) Co., Ltd. · Devices · 2025-01-31
  Class II
• Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Descrip

  ZOLL Medical Corporation · Devices · 2025-02-13
  Class II
• Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

  Olympus Corporation of the Americas · Devices · 2025-11-11
  Class II
• Refer to RES

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

  Remel, Inc · Devices · 2025-02-13
  Class II
• MAXXUS, System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-12-10
  Class II
• Philips L9-3 Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v

  Abbott Laboratories · Devices · 2025-03-18
  Class II
• BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing

  CareFusion 303, Inc. · Devices · 2025-01-23
  Class II
• Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FB

  Olympus Corporation of the Americas · Devices · 2025-05-06
  Class II
• 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.

  AVID Medical, Inc. · Devices · 2025-11-14
  Class II
• Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

  O&M HALYARD INC · Devices · 2025-07-17
  Class II
• UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100

  Beckman Coulter, Inc. · Devices · 2025-06-25
  Class II
• Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version:

  Intuitive Surgical, Inc. · Devices · 2025-12-04
  Class II
• Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-05-23
  Class II
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tub

  Applied Medical Technology Inc · Devices · 2025-08-12
  Class II
• Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H

  Oridion Medical 1987 Ltd. · Devices · 2025-02-17
  Class II
• NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,

  Medtronic Xomed, Inc. · Devices · 2025-03-10
  Class II
• Alphenix INFX-8000C, interventional fluoroscopic x-ray system

  Canon Medical System, USA, INC. · Devices · 2025-12-19
  Class II
• Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-06-20
  Class II
• NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT AS

  Siemens Medical Solutions USA, Inc · Devices · 2025-12-19
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the dis

  Tyber Medical · Devices · 2025-01-21
  Class II
• AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

  Aesculap AG · Devices · 2025-08-18
  Class II
• Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A

  Aesculap Inc · Devices · 2025-09-24
  Class II
• i-STAT EG7+ cartridge. List Number: 03P76-25.

  Abbott Point Of Care Inc. · Devices · 2025-08-21
  Class II
• BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Environmental Pollutants Profile Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Vaginal PH Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining ant

  Beckman Coulter, Inc. · Devices · 2025-07-24
  Class II
• Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

  Altruan GmbH · Devices · 2025-12-19
  Class II
• Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/

  Aesculap Inc · Devices · 2025-09-24
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDI

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Achieva XR Product Numbers: (1) 781153, (2) 781253;

  Philips North America · Devices · 2025-05-29
  Class II
• Rumex Disposable Diamond Dusted ILM Elevator, 12-7523

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI cod

  Abbott Medical · Devices · 2025-02-15
  Class II
• CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 7

  Boston Scientific Corporation · Devices · 2025-09-11
  Class II
• Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Cata

  Becton Dickinson & Co. · Devices · 2025-09-23
  Class II
• ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

  ICU Medical, Inc. · Devices · 2025-04-22
  Class II
• Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conducti

  NIPRO Technical Services, Inc. · Devices · 2025-12-12
  Class II
• Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatme

  RAYSEARCH LABORATORIES AB · Devices · 2025-11-28
  Class II
• Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

  Stryker Corporation · Devices · 2025-06-18
  Class II
• Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

  Orascoptic Surgical Acuity · Devices · 2025-07-03
  Class II
• AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

  Elekta, Inc. · Devices · 2025-12-14
  Class II
• Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

  Securitas Healthcare LLC · Devices · 2025-12-08
  Class II
• Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O

  Medline Industries, LP · Devices · 2025-12-12
  Class II
• Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with th

  Dynex Technologies, Inc. · Devices · 2025-07-16
  Class II
• Gut Microbiome Test Medium

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMO

  BioPro, Inc. · Devices · 2025-09-09
  Class II
• Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ1800

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-19
  Class II
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tub

  Applied Medical Technology Inc · Devices · 2025-08-12
  Class II
• Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CEN

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-08-01
  Class II
• NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number

  Zimmer, Inc. · Devices · 2025-02-27
  Class II
• Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

  Philips Medical Systems (Cleveland) Inc · Devices · 2025-07-17
  Class II
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E

  American Contract Systems Inc · Devices · 2025-07-14
  Class II
• Allura Xper FD10C System Code: (1) 722001

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-01-13
  Class II
• Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007

  Remote Diagnostic Technologies Ltd. · Devices · 2025-04-16
  Class II
• Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of t

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-12-12
  Class II
• Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2025-09-12
  Class II
• Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an ac

  Remote Diagnostic Technologies Ltd. · Devices · 2025-05-30
  Class II
• Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYN

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number:

  Olympus Corporation of the Americas · Devices · 2025-05-06
  Class II
• ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2025-04-24
  Class II
• Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-11
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,

  Fresenius Medical Care Holdings, Inc. · Devices · 2025-04-29
  Class II
• PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

  VANTIVE US HEALTHCARE LLC · Devices · 2025-07-28
  Class II
• LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK,

  American Contract Systems, Inc. · Devices · 2025-04-21
  Class II
• Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper incl

  ICU Medical Inc. · Devices · 2025-08-06
  Class II
• BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers

  Becton Dickinson & Co. · Devices · 2025-09-23
  Class II
• Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clien

  Community Products, LLC · Devices · 2025-12-18
  Class II
• Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) P

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

  Capnia Inc · Devices · 2025-04-21
  Class II
• SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 725

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• 3mensio Workstation (Vascular Fenestrated) software

  PIE Medical Imaging B.V. · Devices · 2025-07-14
  Class II
• Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-09-03
  Class II
• Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-

  Alcon Research LLC · Devices · 2025-02-10
  Class II
• SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Descr

  ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Devices · 2025-09-26
  Class II
• DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065

  Beckman Coulter Inc. · Devices · 2025-02-26
  Class II
• Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4

  Medline Industries, LP · Devices · 2025-10-01
  Class II
• HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STER

  Stryker Sustainability Solutions · Devices · 2025-09-24
  Class II
• LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

  MICROVENTION INC. · Devices · 2025-05-29
  Class II
• DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

  Philips Medical Systems DMC GmbH · Devices · 2025-10-01
  Class II
• Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi

  Hologic, Inc · Devices · 2025-01-15
  Class II
• Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10

  Wilson-Cook Medical Inc. · Devices · 2025-12-15
  Class II
• Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software

  LivaNova USA, Inc. · Devices · 2025-01-03
  Class II
• Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Softw

  RAYSEARCH LABORATORIES AB · Devices · 2025-01-16
  Class II
• PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1

  Ethicon Endo Surgery, LLC · Devices · 2025-03-07
  Class II
• CMS8000 Patient Monitor

  Contec Medical Systems Co., Ltd. · Devices · 2025-04-10
  Class II
• HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

  HeartSine Technologies Ltd · Devices · 2025-09-18
  Class II
• Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I

  Applied Medical Technology Inc · Devices · 2025-10-06
  Class II
• Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical dev

  Immunotech A.S. · Devices · 2025-06-12
  Class II
• GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

  GE Medical Systems, LLC · Devices · 2025-02-18
  Class II
• TOTAL HIP PACK , Model No SMTH06O SMTH06P

  American Contract Systems Inc · Devices · 2025-02-06
  Class II
• Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

  Securitas Healthcare LLC · Devices · 2025-12-08
  Class II
• Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY

  American Contract Systems Inc. · Devices · 2025-09-04
  Class II
• Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventio

  Boston Scientific Corporation · Devices · 2025-08-05
  Class II
• Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050,

  ETAC A/S · Devices · 2025-11-17
  Class II
• NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illuminat

  Stryker Corporation · Devices · 2025-10-31
  Class II
• Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

  Merit Medical Systems, Inc. · Devices · 2025-06-05
  Class II
• Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG

  Rocket Medical Plc · Devices · 2025-11-07
  Class II
• Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the b

  Olympus Corporation of the Americas · Devices · 2025-06-18
  Class II
• Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not

  Fujirebio Diagnostics, Inc. · Devices · 2025-12-11
  Class II
• Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head st

  Orascoptic Surgical Acuity · Devices · 2025-07-03
  Class II
• Baxter Floor mounting column TruSystem 7500, Product Code 1717021

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCES

  Medline Industries, LP · Devices · 2025-11-26
  Class II
• Estrogen & Progesterone Test

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Mod

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

  Medtronic MiniMed, Inc. · Devices · 2025-01-31
  Class II
• WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

  Straumann USA LLC · Devices · 2025-04-17
  Class II
• B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

  Ortho-Clinical Diagnostics, Inc. · Devices · 2025-05-09
  Class II
• Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;

  DAYE (ANNE'S DAY LTD) · Devices · 2025-02-17
  Class II
• Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2025-06-20
  Class II
• Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr

  LeMaitre Vascular, Inc. · Devices · 2025-08-25
  Class II
• TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

  TAS Medical Inc · Devices · 2025-01-27
  Class II
• Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

  Alcon Research LLC · Devices · 2025-08-05
  Class II
• ColoSense Test Kit, Part No. 80-001, component of ColoSense test

  Geneoscopy, Inc. · Devices · 2025-05-20
  Class II
• Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Sof

  Heraeus Medical GmbH (Dental Division) · Devices · 2025-12-09
  Class II
• DA VINCI PACK URO/PROSTATE. Medical convenience kit.

  AVID Medical, Inc. · Devices · 2025-06-11
  Class II
• MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:

  Intuitive Surgical, Inc. · Devices · 2025-11-07
  Class II
• SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

  Beckman Coulter Inc. · Devices · 2025-09-17
  Class II
• RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

  Remel, Inc · Devices · 2025-11-12
  Class II
• CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310

  Defibtech, LLC · Devices · 2025-03-18
  Class II
• PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PER

  B BRAUN MEDICAL INC · Devices · 2025-09-18
  Class II
• LIFEPAK 35 ECG cable REF 11111-000041

  Physio-Control, Inc. · Devices · 2025-01-21
  Class II
• A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractu

  Tyber Medical · Devices · 2025-01-21
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit

  Agilent Technologies, Inc. · Devices · 2025-03-20
  Class II
• Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-05-22
  Class II
• BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis"

  CareFusion 303, Inc. · Devices · 2025-05-08
  Class II
• BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF:

  BD SWITZERLAND SARL · Devices · 2025-05-12
  Class II
• Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

  Zimmer, Inc. · Devices · 2025-12-02
  Class II
• Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

  Olympus Corporation of the Americas · Devices · 2025-10-22
  Class II
• Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Proxima Drape labeled as FACE LIFT. Sterile surgical drape.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-02-13
  Class II
• Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained

  Zimmer, Inc. · Devices · 2025-03-24
  Class II
• Baxter Floor mounting column TS 7500 U, Product Code 1730732

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premie

  GE Medical Systems China Co., Ltd. · Devices · 2025-05-16
  Class II
• Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve,

  Cardinal Health 200, LLC · Devices · 2025-09-18
  Class II
• Baxter Mobile column TruSystem 7500, Product Code 1717023

  Baxter Healthcare Corporation · Devices · 2025-02-25
  Class II
• Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B

  Medline Industries, LP · Devices · 2025-12-24
  Class II
• Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

  Advanced Bionics, LLC · Devices · 2025-11-27
  Class II
• Menopause Test Cassette (Urine)

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Allura Xper FD10; Model Number: 722026;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-01-09
  Class II
• MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RaySta

  RAYSEARCH LABORATORIES AB · Devices · 2025-08-08
  Class II
• NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-

  Northeast Scientific Inc. · Devices · 2025-08-29
  Class II
• Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes

  Olympus Corporation of the Americas · Devices · 2025-11-14
  Class II
• Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300

  Barco N.V. · Devices · 2025-05-09
  Class II
• Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system

  SEDECAL SA · Devices · 2025-06-10
  Class II
• Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

  Diasol, Inc · Devices · 2025-11-05
  Class II
• VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The V

  Merge Healthcare, Inc. · Devices · 2025-02-19
  Class II
• Medline procedure kits, labeled as: HAND, REF DYNJ902002J

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-19
  Class II
• BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a

  CareFusion 303, Inc. · Devices · 2025-11-06
  Class II
• Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

  Cordis US Corp · Devices · 2025-03-04
  Class II
• MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan

  Beckman Coulter, Inc. · Devices · 2025-09-08
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO P

  Medline Industries, LP · Devices · 2025-09-30
  Class II
• Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with

  Belmont Instrument LLC · Devices · 2025-03-31
  Class II
• Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V

  Exactech, Inc. · Devices · 2025-09-05
  Class II
• IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fr

  Tyber Medical · Devices · 2025-01-21
  Class II
• Allura Xper FD20; Model Number: 722006;

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2025-12-15
  Class II
• All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00

  CareFusion 303, Inc. · Devices · 2025-09-30
  Class II
• Philips S7-3t Transducer.

  Philips Ultrasound, Inc · Devices · 2025-05-28
  Class II
• Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551

  MICROVENTION INC. · Devices · 2025-09-05
  Class II
• Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monit

  Edan Diagnostics · Devices · 2025-10-24
  Class II
• Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a

  Sysmex America, Inc. · Devices · 2025-01-06
  Class II
• IntelliVue MP70. Product Number: M8007A.

  Philips North America Llc · Devices · 2025-10-31
  Class II
• ADVIA¿ 120/2120/2120i SETpoint Calibrator

  Siemens Healthcare Diagnostics, Inc. · Devices · 2025-06-04
  Class II
• Continuous Glucose Monitor (CGM)

  GET TESTED INTERNATIONAL AB · Devices · 2025-11-03
  Class II
• BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

  C.R. Bard Inc · Devices · 2025-11-06
  Class II
• SQ40S Blood Transfusion Filter

  GVS TM, Inc · Devices · 2025-11-03
  Class II
• IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure ga

  Boston Scientific Corporation · Devices · 2025-03-24
  Class II
• Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K;

  Medline Industries, LP · Devices · 2025-12-16
  Class II
• Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R,

  Aesculap Inc · Devices · 2025-01-31
  Class II
• Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

  LeMaitre Vascular, Inc. · Devices · 2025-04-11
  Class II
• Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885

  BALT USA, LLC · Devices · 2025-05-08
  Class II
• Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version

  Insulet Corporation · Devices · 2025-05-23
  Class II
• Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

  Vortex Surgical Inc. · Devices · 2025-12-16
  Class II
• stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Ins

  Tornier S.A.S. · Devices · 2025-03-05
  Class II
• epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Softw

  Siemens Healthcare Diagnostics Inc · Devices · 2025-03-19
  Class II
• Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-

  CareFusion 303, Inc. · Devices · 2025-09-30
  Class II
• CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Prod

  Baxter Healthcare Corporation · Devices · 2025-08-29
  Class II
• Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implan

  Hiossen Inc. · Devices · 2025-01-27
  Class II
• Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Vivoo Vaginal pH Test

  Changchun Wancheng Bio-Electron Co., Ltd. · Devices · 2025-11-22
  Class II
• Centurion Sterile Weitlaner Retractor, Reorder: 67315

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-04-09
  Class II
• TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev

  Integra LifeSciences Corp. (NeuroSciences) · Devices · 2025-10-03
  Class II
• Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2025-03-03
  Class II
• Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

  B Braun Medical Inc · Devices · 2025-10-29
  Class II
• Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or

  MCKESSON CORPORATION · Drugs · 2024-02-12
  Class II
• Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

  Genentech, Inc. · Drugs · 2024-05-20
  Class II
• Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 024

  Thea Pharma, Inc. · Drugs · 2024-03-05
  Class II
• Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Vio

  VIONA PHARMACEUTICALS INC · Drugs · 2024-10-29
  Class II
• Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UP

  Golden State Medical Supply Inc. · Drugs · 2024-01-12
  Class II
• OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturista

  MexHealth LLC · Drugs · 2024-05-22
  Class II
• Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Demo

  Keystone Industries · Drugs · 2024-11-14
  Class II
• First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.

  Zhejiang Jingwei Pharmaceutical Co., Ltd. · Drugs · 2024-09-11
  Class II
• Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON,

  Brands International Corporation · Drugs · 2024-11-13
  Class II
• Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Do

  Global Corporation · Drugs · 2024-02-16
  Class II
• S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix,

  Specialty Process Labs LLC · Drugs · 2024-03-01
  Class II
• glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Hea

  Amerisource Health Services LLC · Drugs · 2024-12-17
  Class II
• Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277

  BLI International, Inc. · Drugs · 2024-10-21
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited,

  Amerisource Health Services LLC · Drugs · 2024-11-14
  Class II
• EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled

  Regeneron Pharmaceuticals Inc · Drugs · 2024-05-15
  Class II
• Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180

  Lupin Pharmaceuticals Inc. · Drugs · 2024-10-23
  Class II
• Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceut

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2024-02-07
  Class II
• fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 K

  IntegraDose Compounding Services LLC · Drugs · 2024-03-22
  Class II
• ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 270

  Midlab Incorporated · Drugs · 2024-11-06
  Class II
• Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: L

  Lupin Pharmaceuticals Inc. · Drugs · 2024-05-30
  Class II
• Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US

  Eugia US LLC · Drugs · 2024-07-26
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutica

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-12-06
  Class II
• Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe,

  IntegraDose Compounding Services LLC · Drugs · 2024-01-22
  Class II
• THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, I

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8

  Aurobindo Pharma USA Inc · Drugs · 2024-11-07
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals I

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-12-11
  Class II
• Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by

  Eugia US LLC · Drugs · 2024-05-23
  Class II
• Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-01-08
  Class II
• Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottl

  NATCO Pharma Limited · Drugs · 2024-03-27
  Class II
• ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chatt

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd f

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-11-01
  Class II
• Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapo

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2024-11-07
  Class II
• Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-

  Aurobindo Pharma USA Inc · Drugs · 2024-11-07
  Class II
• Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical I

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-02-05
  Class II
• Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, N

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark P

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-13
  Class II
• CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestc

  Bestco LLC · Drugs · 2024-01-19
  Class II
• Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Ph

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin

  Lupin Pharmaceuticals Inc. · Drugs · 2024-04-24
  Class II
• Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading

  FDC Limited · Drugs · 2024-12-16
  Class II
• Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-90

  AvKARE · Drugs · 2024-10-18
  Class II
• Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahw

  RemedyRepack Inc. · Drugs · 2024-06-26
  Class II
• Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melvi

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Den

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, I

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm

  Provepharm Inc. · Drugs · 2024-11-22
  Class II
• Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets

  Mylan Institutional, Inc. · Drugs · 2024-11-19
  Class II
• Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets

  Mylan Institutional, Inc. · Drugs · 2024-11-19
  Class II
• Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D

  SOMERSET THERAPEUTICS LLC · Drugs · 2024-04-24
  Class II
• Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceuti

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets ea

  Mylan Institutional, Inc. · Drugs · 2024-11-19
  Class II
• Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 2015

  Granules Pharmaceuticals Inc. · Drugs · 2024-12-18
  Class II
• THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 p

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compo

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales,

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-08-08
  Class II
• Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: A

  Golden State Medical Supply Inc. · Drugs · 2024-02-14
  Class II
• Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Prin

  Eugia US LLC · Drugs · 2024-02-20
  Class II
• Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceu

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2024-02-13
  Class II
• Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianap

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2024-11-07
  Class II
• Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reacti

  Curium US, LLC · Drugs · 2024-11-26
  Class II
• buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only,

  Amerisource Health Services LLC · Drugs · 2024-06-24
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-4

  Amerisource Health Services LLC · Drugs · 2024-11-14
  Class II
• Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-08-06
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, H

  Amerisource Health Services LLC · Drugs · 2024-12-06
  Class II
• PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, T

  Seatex LLC · Drugs · 2024-02-19
  Class II
• Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-g

  Zeco LLC · Drugs · 2024-08-05
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmac

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-11-01
  Class II
• Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Int

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-09

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2024-02-20
  Class II
• Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets

  Mylan Institutional, Inc. · Drugs · 2024-11-19
  Class II
• Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: I

  Imprimis NJOF, LLC · Drugs · 2024-04-10
  Class II
• Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC

  FDC Limited · Drugs · 2024-04-25
  Class II
• Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc.,

  B. Braun Medical Inc · Drugs · 2024-03-06
  Class II
• Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratori

  Ascend Laboratories, LLC · Drugs · 2024-09-03
  Class II
• Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE

  Eugia US LLC · Drugs · 2024-02-22
  Class II
• suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56

  SYNCHRONICITY SPA INC, DBA SUNTE · Drugs · 2024-05-24
  Class II
• Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LL

  Eugia US LLC · Drugs · 2024-12-27
  Class II
• Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceutic

  Lupin Pharmaceuticals Inc. · Drugs · 2024-05-08
  Class II
• Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-04-19
  Class II
• EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603

  EnviroServe Chemicals Inc. · Drugs · 2024-09-18
  Class II
• GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-0

  Nomax Inc · Drugs · 2024-04-19
  Class II
• Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: S

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Li

  Eli Lilly & Company · Drugs · 2024-03-12
  Class II
• Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Wa

  Brassica Pharma Pvt Ltd · Drugs · 2024-01-30
  Class II
• Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 1908

  Dercher Enterprises, Inc., DBA Gordon Laboratories · Drugs · 2024-04-12
  Class II
• First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First

  First Aid Beauty Ltd · Drugs · 2024-12-23
  Class II
• Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-0

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-70

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In

  American Regent, Inc. · Drugs · 2024-11-11
  Class II
• VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Ph

  Apothecus Pharmaceutical Corp. · Drugs · 2024-03-21
  Class II
• Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I

  ACCORD HEALTHCARE, INC. · Drugs · 2024-11-08
  Class II
• FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., La

  Nomax Inc · Drugs · 2024-04-19
  Class II
• Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hy

  Amerisource Health Services LLC · Drugs · 2024-12-06
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-11-01
  Class II
• Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For

  American Regent, Inc. · Drugs · 2024-11-11
  Class II
• Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This

  SSM Health Care St. Louis DBA SSM St. Clare Health Center · Drugs · 2024-02-29
  Class II
• safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Glut

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 7051

  RemedyRepack Inc. · Drugs · 2024-12-02
  Class II
• Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shrev

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-06-07
  Class II
• Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Ac

  ACCORD HEALTHCARE, INC. · Drugs · 2024-10-01
  Class II
• Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patr

  Winder Laboratories, LLC · Drugs · 2024-05-28
  Class II
• Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphi

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-06-27
  Class II
• Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharm

  VIONA PHARMACEUTICALS INC · Drugs · 2024-12-10
  Class II
• Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

  AvKARE · Drugs · 2024-11-27
  Class II
• Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets

  Mylan Institutional, Inc. · Drugs · 2024-11-19
  Class II
• Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIV

  Midlab Incorporated · Drugs · 2024-11-06
  Class II
• Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bot

  Den-Mat Holdings, LLC · Drugs · 2024-01-16
  Class II
• Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharm

  Eugia US LLC · Drugs · 2024-02-20
  Class II
• Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, In

  Nivagen Pharmaceuticals Inc · Drugs · 2024-09-24
  Class II
• Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental C

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64

  FDC Limited · Drugs · 2024-08-12
  Class II
• Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorpha

  LNK International, Inc. · Drugs · 2024-11-14
  Class II
• PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases

  Seatex LLC · Drugs · 2024-02-19
  Class II
• NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433

  Safecor Health, LLC · Drugs · 2024-11-11
  Class II
• BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELE

  PREQUEL SKIN · Drugs · 2024-08-28
  Class II
• Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials

  Par Sterile Products LLC · Drugs · 2024-01-11
  Class II
• Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 2

  Bestco LLC · Drugs · 2024-01-19
  Class II
• Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, L

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran

  FDC Limited · Drugs · 2024-10-29
  Class II
• Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-06-21
  Class II
• Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Pro

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, ND

  Aurobindo Pharma USA Inc. · Drugs · 2024-04-24
  Class II
• Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341,

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisi

  Preferred Pharmaceuticals, Inc. · Drugs · 2024-08-08
  Class II
• Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx On

  Jubilant Draximage Inc., dba Jubilant Radiopharma · Drugs · 2024-11-22
  Class II
• NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & M

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla

  Lupin Pharmaceuticals Inc. · Drugs · 2024-01-05
  Class II
• Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pa

  PACIRA PHARMACEUTICALS INC · Drugs · 2024-06-12
  Class II
• Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-30
  Class II
• EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canto

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets

  Mylan Institutional, Inc. · Drugs · 2024-11-19
  Class II
• Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc.

  AvKARE · Drugs · 2024-12-04
  Class II
• Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in

  Eugia US LLC · Drugs · 2024-02-20
  Class II
• Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen

  Trigen Laboratories · Drugs · 2024-06-17
  Class II
• Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Cant

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Compa

  Neogen Corporation · Drugs · 2024-10-08
  Class II
• LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactur

  Regenerative Processing Plant, LLC · Drugs · 2024-12-10
  Class II
• Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottl

  Rising Pharma Holding, Inc. · Drugs · 2024-12-30
  Class II
• Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac

  Advanced Accelerator Applications USA, Inc. · Drugs · 2024-09-23
  Class II
• S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs

  Specialty Process Labs LLC · Drugs · 2024-03-01
  Class II
• Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Pack

  Amerisource Health Services LLC · Drugs · 2024-01-11
  Class II
• Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus,

  Amerisource Health Services LLC · Drugs · 2024-01-25
  Class II
• Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelp

  Lannett Company Inc. · Drugs · 2024-10-25
  Class II
• Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton

  Cipla USA, Inc. · Drugs · 2024-03-26
  Class II
• Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count b

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-07-31
  Class II
• 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottl

  Generitech Corporation · Drugs · 2024-11-22
  Class II
• Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., US

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-10
  Class II
• minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Labora

  EPI Health, LLC · Drugs · 2024-04-23
  Class II
• Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-03-04
  Class II
• STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 1

  Homeocare Laboratories, Inc. · Drugs · 2024-06-05
  Class II
• Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 2

  Bestco LLC · Drugs · 2024-01-19
  Class II
• Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma L

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2024-02-07
  Class II
• Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manu

  Rubicon Research Private Limited · Drugs · 2024-05-06
  Class II
• TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucch

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Lu

  Pfizer Inc. · Drugs · 2024-05-20
  Class II
• Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT

  Direct Rx · Drugs · 2024-08-09
  Class II
• Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Ph

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-13
  Class II
• Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 4

  Safecor Health, LLC · Drugs · 2024-11-11
  Class II
• Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160

  Bestco LLC · Drugs · 2024-01-19
  Class II
• Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7

  B. Braun Medical Inc · Drugs · 2024-03-22
  Class II
• Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44

  ACCORD HEALTHCARE, INC. · Drugs · 2024-10-10
  Class II
• Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Heal

  Tailstorm Health INC · Drugs · 2024-11-06
  Class II
• Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2024-01-10
  Class II
• Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous I

  American Regent, Inc. · Drugs · 2024-05-13
  Class II
• Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceutical

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-03-28
  Class II
• 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Driv

  Seatex LLC · Drugs · 2024-02-19
  Class II
• MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx on

  Sagent Pharmaceuticals · Drugs · 2024-04-25
  Class II
• TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 7051

  RemedyRepack Inc. · Drugs · 2024-05-02
  Class II
• Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 6818

  Lupin Pharmaceuticals Inc. · Drugs · 2024-10-23
  Class II
• Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

  OMEZA LLC · Drugs · 2024-01-19
  Class II
• Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30

  AvKARE · Drugs · 2024-11-27
  Class II
• Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, I

  Lupin Pharmaceuticals Inc. · Drugs · 2024-12-20
  Class II
• Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Pro

  Mallinckrodt Hospital Products Inc. · Drugs · 2024-02-06
  Class II
• Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-03-04
  Class II
• TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, In

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactu

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2024-02-09
  Class II
• Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-

  Lupin Pharmaceuticals Inc. · Drugs · 2024-10-23
  Class II
• Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distribut

  AbbVie Inc. · Drugs · 2024-09-16
  Class II
• Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

  Cipla USA, Inc. · Drugs · 2024-10-23
  Class II
• PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacter

  Seatex LLC · Drugs · 2024-02-19
  Class II
• Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri

  Ascend Laboratories, LLC · Drugs · 2024-12-12
  Class II
• traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plain

  Rubicon Research Private Limited · Drugs · 2024-04-26
  Class II
• Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets

  Global Corporation · Drugs · 2024-02-16
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-03-26
  Class II
• Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactu

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822

  Consumer Product Partners, LLC · Drugs · 2024-05-28
  Class II
• Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, ND

  Aurobindo Pharma USA Inc. · Drugs · 2024-04-24
  Class II
• Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,

  Lupin Pharmaceuticals Inc. · Drugs · 2024-01-03
  Class II
• Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hy

  Amerisource Health Services LLC · Drugs · 2024-12-06
  Class II
• AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

  C & A Naturistics · Drugs · 2024-10-08
  Class II
• Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri

  Ascend Laboratories, LLC · Drugs · 2024-12-12
  Class II
• EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOC

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India.,

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-10-09
  Class II
• Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenvill

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-10-22
  Class II
• Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle,

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2024-06-18
  Class II
• Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Via

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-07-02
  Class II
• Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Bal

  Lupin Pharmaceuticals Inc. · Drugs · 2024-08-21
  Class II
• Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-0

  Safecor Health, LLC · Drugs · 2024-11-11
  Class II
• Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Marylan

  Lupin Pharmaceuticals Inc. · Drugs · 2024-01-05
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Mar

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-05-17
  Class II
• Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bri

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2024-03-25
  Class II
• Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock

  Pfizer Inc. · Drugs · 2024-05-20
  Class II
• Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12

  Medisca Inc. · Drugs · 2024-06-26
  Class II
• NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per ca

  Brands International Corporation · Drugs · 2024-06-10
  Class II
• VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By:

  Apothecus Pharmaceutical Corp. · Drugs · 2024-11-22
  Class II
• medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for:

  Eugia US LLC · Drugs · 2024-12-18
  Class II
• Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plasti

  Equibal Inc · Drugs · 2024-06-26
  Class II
• Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Vio

  VIONA PHARMACEUTICALS INC · Drugs · 2024-09-24
  Class II
• Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park

  Contract Pharmacal Corporation · Drugs · 2024-05-20
  Class II
• M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Su

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Di

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-10-10
  Class II
• Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst

  Aurobindo Pharma USA Inc · Drugs · 2024-12-06
  Class II
• boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkwa

  Midlab Incorporated · Drugs · 2024-11-06
  Class II
• Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laborato

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-07-09
  Class II
• Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compa

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2024-02-20
  Class II
• Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industrie

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industri

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-04-29
  Class II
• HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4

  Zeco LLC · Drugs · 2024-08-05
  Class II
• chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-12-11
  Class II
• Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Mo

  Viatris Inc · Drugs · 2024-12-23
  Class II
• Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only

  Baxter Healthcare Corporation · Drugs · 2024-06-17
  Class II
• Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal p

  Noven Pharmaceuticals Inc · Drugs · 2024-10-31
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-04-29
  Class II
• JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (

  Viatris Inc · Drugs · 2024-11-18
  Class II
• NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MS

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Phar

  Akron Pharma, Inc. · Drugs · 2024-10-15
  Class II
• Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Mei

  Pharma Nobis LLC · Drugs · 2024-05-01
  Class II
• Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LL

  Amerisource Health Services LLC · Drugs · 2024-12-13
  Class II
• Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-07-22
  Class II
• CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 g

  Brassica Pharma Pvt Ltd · Drugs · 2024-01-30
  Class II
• Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS

  Pharma Nobis LLC · Drugs · 2024-05-01
  Class II
• Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured f

  Micro Labs Limited · Drugs · 2024-02-12
  Class II
• Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactu

  Evaric Pharmaceuticals Inc. · Drugs · 2024-11-15
  Class II
• Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Mac

  MACLEODS PHARMA USA, INC · Drugs · 2024-05-07
  Class II
• DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC

  PD-Rx Pharmaceuticals, Inc. · Drugs · 2024-12-04
  Class II
• Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

  AvKARE · Drugs · 2024-11-27
  Class II
• Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2024-02-07
  Class II
• Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2024-02-20
  Class II
• UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

  MXBBB · Drugs · 2024-11-14
  Class II
• Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-04-29
  Class II
• Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pv

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2024-01-15
  Class II
• Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57

  Rising Pharma Holding, Inc. · Drugs · 2024-11-19
  Class II
• Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Ma

  PACIRA PHARMACEUTICALS INC · Drugs · 2024-05-07
  Class II
• Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, H

  Amerisource Health Services LLC · Drugs · 2024-11-14
  Class II
• Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distribu

  Rising Pharma Holding, Inc. · Drugs · 2024-12-30
  Class II
• IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-08-06
  Class II
• Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only

  EMPOWER CLINIC SERVICES LLC · Drugs · 2024-08-02
  Class II
• OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den

  Den-Mat Holdings, LLC · Drugs · 2024-01-16
  Class II
• Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

  Preferred Pharmaceuticals, Inc. · Drugs · 2024-05-10
  Class II
• NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MS

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

  OMEZA LLC · Drugs · 2024-01-19
  Class II
• Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Ph

  Baxter Healthcare Corporation · Drugs · 2024-10-30
  Class II
• Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE P

  Brassica Pharma Pvt Ltd · Drugs · 2024-01-30
  Class II
• Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44

  ACCORD HEALTHCARE, INC. · Drugs · 2024-10-10
  Class II
• Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Par

  Alpha Aromatics · Drugs · 2024-01-25
  Class II
• Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., M

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-06-28
  Class II
• Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370

  Guru Inc. · Drugs · 2024-06-26
  Class II
• Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, M

  Viatris Inc · Drugs · 2024-12-23
  Class II
• Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-10-09
  Class II
• Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, C

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2024-09-11
  Class II
• Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medte

  Denison Pharmaceuticals, LLC · Drugs · 2024-05-28
  Class II
• TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Deluc

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Be

  Bestco LLC · Drugs · 2024-01-19
  Class II
• Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th

  Fagron Compounding Services · Drugs · 2024-08-15
  Class II
• Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig

  Viatris Inc · Drugs · 2024-04-30
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran

  FDC Limited · Drugs · 2024-07-18
  Class II
• Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal

  Midlab Incorporated · Drugs · 2024-11-06
  Class II
• Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mf

  Mallinckrodt Hospital Products Inc. · Drugs · 2024-02-06
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manu

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-11-01
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-11-01
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutic

  Breckenridge Pharmaceutical, Inc · Drugs · 2024-12-06
  Class II
• Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richar

  Midlab Incorporated · Drugs · 2024-11-06
  Class II
• Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In

  American Regent, Inc. · Drugs · 2024-11-11
  Class II
• Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial

  Baxter Healthcare Corporation · Drugs · 2024-01-23
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmac

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-11-01
  Class II
• ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc

  Hikma Injectables USA Inc · Drugs · 2024-12-19
  Class II
• TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc,

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face

  HONEYWELL INC · Drugs · 2024-03-29
  Class II
• TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Del

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, O

  JR Watkins · Drugs · 2024-11-01
  Class II
• Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceut

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-30
  Class II
• Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228

  NATCO Pharma Limited · Drugs · 2024-02-01
  Class II
• GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax,

  Nomax Inc · Drugs · 2024-04-19
  Class II
• Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottle

  Golden State Medical Supply Inc. · Drugs · 2024-05-13
  Class II
• Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LL

  EPI Health, LLC · Drugs · 2024-04-23
  Class II
• Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bott

  Lupin Pharmaceuticals Inc. · Drugs · 2024-02-05
  Class II
• niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou

  American Regent, Inc. · Drugs · 2024-05-14
  Class II
• Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/b

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-09-24
  Class II
• FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactu

  Nomax Inc · Drugs · 2024-04-19
  Class II
• EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactur

  Regeneron Pharmaceuticals Inc · Drugs · 2024-04-23
  Class II
• Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg

  Bausch Health Companies, Inc. · Drugs · 2024-02-02
  Class II
• ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum P

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier

  Vivier Pharma, Inc. · Drugs · 2024-09-03
  Class II
• Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-01-18
  Class II
• TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aur

  FDC Limited · Drugs · 2024-12-05
  Class II
• Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules In

  Granules Pharmaceuticals Inc. · Drugs · 2024-12-30
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-04-17
  Class II
• ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, T

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane,

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, For

  Trinity Gold Nutrition · Drugs · 2024-11-06
  Class II
• Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0854

  Macleods Pharmaceuticals Ltd · Drugs · 2024-11-25
  Class II
• CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 693

  FDC Limited · Drugs · 2024-07-23
  Class II
• Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-

  Aurobindo Pharma USA Inc · Drugs · 2024-11-07
  Class II
• Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, M

  Micro Labs Limited · Drugs · 2024-02-09
  Class II
• Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canad

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-06-04
  Class II
• Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Comp

  Empower Pharmacy · Drugs · 2024-09-05
  Class II
• Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla

  Lupin Pharmaceuticals Inc. · Drugs · 2024-03-21
  Class II
• Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440

  ACCORD HEALTHCARE, INC. · Drugs · 2024-10-10
  Class II
• phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Ro

  Hikma Injectables USA Inc · Drugs · 2024-12-19
  Class II
• Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services,

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He

  Hikma Pharmaceuticals USA Inc. · Drugs · 2024-03-12
  Class II
• Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., E

  Rising Pharma Holding, Inc. · Drugs · 2024-12-30
  Class II
• Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Bl

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-03-07
  Class II
• Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 7113

  IntegraDose Compounding Services LLC · Drugs · 2024-01-12
  Class II
• Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226

  Little Moon Essentials LLC · Drugs · 2024-06-20
  Class II
• Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-01-02
  Class II
• Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig

  Viatris Inc · Drugs · 2024-04-30
  Class II
• Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution an

  BE PHARMACEUTICALS AG · Drugs · 2024-01-10
  Class II
• Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB

  ARG Laboratories, Inc. · Drugs · 2024-04-17
  Class II
• Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

  Safecor Health, LLC · Drugs · 2024-11-11
  Class II
• Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc

  Apotex Corp. · Drugs · 2024-02-09
  Class II
• Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint fla

  Keystone Industries · Drugs · 2024-10-17
  Class II
• IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-08-06
  Class II
• Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Impr

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View

  Henry Schein Inc. and Glove Club HSI Gloves Inc. · Drugs · 2024-01-17
  Class II
• Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 10

  Rising Pharma Holding, Inc. · Drugs · 2024-11-19
  Class II
• MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutiona

  Midlab Incorporated · Drugs · 2024-11-06
  Class II
• Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208

  Mckesson Medical-Surgical Inc. Corporate Office · Drugs · 2024-09-11
  Class II
• Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,

  Ascend Laboratories, LLC · Drugs · 2024-01-16
  Class II
• SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84

  ProRx LLC · Drugs · 2024-08-22
  Class II
• Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 762

  Cipla USA, Inc. · Drugs · 2024-10-23
  Class II
• Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

  Safecor Health, LLC · Drugs · 2024-11-11
  Class II
• TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc,

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply

  Keystone Industries · Drugs · 2024-11-14
  Class II
• DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Se

  Fresenius Medical Care Holdings, Inc. · Drugs · 2024-06-18
  Class II
• Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518

  RemedyRepack Inc. · Drugs · 2024-05-31
  Class II
• FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx On

  SSM Health Care St. Louis DBA SSM St. Clare Health Center · Drugs · 2024-02-29
  Class II
• Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx on

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 pa

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Dis

  Seatex LLC · Drugs · 2024-02-19
  Class II
• Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patter

  Keystone Industries · Drugs · 2024-11-14
  Class II
• Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (

  Viatris Inc · Drugs · 2024-11-18
  Class II
• Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth,

  Coast Quality Pharmacy, LLC dba Anazao Health · Drugs · 2024-04-24
  Class II
• Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc.,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-05-10
  Class II
• Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Gl

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-01-04
  Class II
• Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-06-28
  Class II
• Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc.,

  Rising Pharma Holding, Inc. · Drugs · 2024-11-19
  Class II
• Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, N

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-10-09
  Class II
• hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Plat

  Optikem International, Inc. · Drugs · 2024-02-29
  Class II
• Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laborat

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-05-23
  Class II
• Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin

  Lupin Pharmaceuticals Inc. · Drugs · 2024-04-24
  Class II
• Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Com

  TAILSTORM HEALTH INC · Drugs · 2024-07-03
  Class II
• Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Dis

  AbbVie Inc. · Drugs · 2024-09-16
  Class II
• Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by

  Brassica Pharma Pvt Ltd · Drugs · 2024-01-30
  Class II
• Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service

  Fresenius Kabi Compounding, LLC · Drugs · 2024-09-25
  Class II
• HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LL

  Unexo Life Sciences Private Limited · Drugs · 2024-10-24
  Class II
• Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. N

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Labora

  EPI Health, LLC · Drugs · 2024-04-23
  Class II
• Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902

  AvKARE · Drugs · 2024-10-18
  Class II
• PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; M

  Regenerative Processing Plant, LLC · Drugs · 2024-12-10
  Class II
• Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081,

  Granules Pharmaceuticals Inc. · Drugs · 2024-07-31
  Class II
• Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imp

  Imprimis NJOF, LLC · Drugs · 2024-05-14
  Class II
• Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Phar

  VIONA PHARMACEUTICALS INC · Drugs · 2024-12-10
  Class II
• Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited

  Amerisource Health Services LLC · Drugs · 2024-12-06
  Class II
• Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-08-30
  Class II
• Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville,

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-10-22
  Class II
• LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Co

  Neogen Corporation · Drugs · 2024-10-08
  Class II
• VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

  Boston Scientific Corporation · Devices · 2024-07-18
  Class II
• EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

  Enchroma Inc · Devices · 2024-09-06
  Class II
• Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of sa

  Radiometer Medical ApS · Devices · 2024-05-31
  Class II
• 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

  Abbott Vascular Inc · Devices · 2024-11-06
  Class II
• Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

  Maquet Medical Systems USA · Devices · 2024-04-15
  Class II
• Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-01-22
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in),

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Produ

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

  CareFusion 303, Inc. · Devices · 2024-08-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

  GE Medical Systems, LLC · Devices · 2024-11-18
  Class II
• Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for

  Philips North America Llc · Devices · 2024-04-22
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

  Alcon Research LLC · Devices · 2024-05-23
  Class II
• BD Pyxis(TM) Anesthesia Station 4000, REF: 338

  CareFusion 303, Inc. · Devices · 2024-04-15
  Class II
• Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

  Covidien · Devices · 2024-01-09
  Class II
• OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administra

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

  Olympus Corporation of the Americas · Devices · 2024-09-04
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syrin

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software

  Lucid Diagnostics, Inc. · Devices · 2024-04-24
  Class II
• Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-09-04
  Class II
• EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both ped

  Boston Scientific Corporation · Devices · 2024-02-20
  Class II
• Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

  Covidien, LP · Devices · 2024-02-28
  Class II
• Ingenia 1.5T S, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• MEDLINE KIT CV I II, REF DYNJ906071B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shap

  Stryker Neurovascular · Devices · 2024-04-18
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Non-ablative Fractional Laser Systems, Model: WFB-01

  WINGDERM ELECTRO-OPTICS LTD. · Devices · 2024-08-23
  Class II
• Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

  Maquet Cardiovascular, LLC · Devices · 2024-10-16
  Class II
• AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

  Alere San Diego, Inc. · Devices · 2024-03-01
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-10-29
  Class II
• Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-26
  Class II
• TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial

  Sophysa S.A. · Devices · 2024-04-09
  Class II
• DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl

  Beckman Coulter Mishima K.K. · Devices · 2024-06-05
  Class II
• Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar

  Cook Incorporated · Devices · 2024-09-16
  Class II
• Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

  Intrinsic Therapeutics, Inc. · Devices · 2024-07-25
  Class II
• BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catal

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-11-11
  Class II
• Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

  Shimadzu Corp. Analytical & Measuring Instruments Div. · Devices · 2024-10-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou

  Olympus Corporation of the Americas · Devices · 2024-07-01
  Class II
• Pacemaker, COPM11B; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-22
  Class II
• Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• see RES for description

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli

  Stryker Corporation · Devices · 2024-10-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

  Philips North America Llc · Devices · 2024-04-19
  Class II
• Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-ce

  Zimmer GmbH · Devices · 2024-08-08
  Class II
• Neria Soft Infusion Set, Product Code 507302, intravascular administration set

  Unomedical A/S · Devices · 2024-03-05
  Class II
• Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-05-07
  Class II
• REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

  Stryker Sustainability Solutions · Devices · 2024-05-31
  Class II
• Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rap

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• AMS Artificial Urinary Sphincter Control Pump

  Boston Scientific Corporation · Devices · 2024-10-28
  Class II
• Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the pat

  Spacelabs Healthcare, Ltd. · Devices · 2024-11-25
  Class II
• Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted

  Life Technologies Corporation · Devices · 2024-02-07
  Class II
• Achieva 1.5T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

  Philips North America Llc · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,

  Stryker Corporation · Devices · 2024-07-24
  Class II
• Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

  Karl Storz Endoscopy · Devices · 2024-02-27
  Class II
• Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product De

  CooperSurgical, Inc. · Devices · 2024-11-15
  Class II
• MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display

  Barco N.V. · Devices · 2024-04-24
  Class II
• Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

  Abbott GmbH · Devices · 2024-03-04
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b

  Medicrea International · Devices · 2024-12-03
  Class II
• Intera 1.5T Omni/Stellar, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• KIT,SPINE LH Convenience kit, SKU DYNJ906448A.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

  Baxter Healthcare Corporation · Devices · 2024-03-15
  Class II
• Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Ve

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-05-07
  Class II
• BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut

  Young Dental Manufacturing I, LLC · Devices · 2024-08-23
  Class II
• Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

  GE Medical Systems, LLC · Devices · 2024-11-18
  Class II
• ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

  Philips North America · Devices · 2024-01-03
  Class II
• HAND PACK-Procedure Kit Catalog Number: WEHD16B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 810

  Sol-Millennium Medical Inc. · Devices · 2024-05-09
  Class II
• Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

  Stryker Sustainability Solutions · Devices · 2024-07-02
  Class II
• MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Achieva 3.0T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Pro

  Philips North America Llc · Devices · 2024-05-03
  Class II
• basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use i

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.2

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) adm

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4

  Getinge Usa Sales Inc · Devices · 2024-05-29
  Class II
• COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100

  Howmedica Osteonics Corp. · Devices · 2024-08-05
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

  Baxter Healthcare Corporation · Devices · 2024-10-11
  Class II
• Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

  Merit Medical Systems, Inc. · Devices · 2024-03-14
  Class II
• BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

  Bio-Rad Laboratories · Devices · 2024-02-15
  Class II
• Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,

  Masimo Corporation · Devices · 2024-02-15
  Class II
• Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

  Cardinal Health 200, LLC · Devices · 2024-03-27
  Class II
• Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-12
  Class II
• ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona

  Siemens AG/Siemens Healthcare GmbH · Devices · 2024-06-26
  Class II
• The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng

  Maquet Cardiovascular, LLC · Devices · 2024-05-31
  Class II
• FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal micro

  BioFire Diagnostics, LLC · Devices · 2024-01-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,

  Coloplast Manufacturing US, LLC · Devices · 2024-12-02
  Class II
• Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A P

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti

  Stryker Corporation · Devices · 2024-07-24
  Class II
• 8MM,MEGA SUTURECUT ND,IS4000 REF 471309

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Colonoscope, Model Number PCF-H190DL.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

  Stryker Orthopaedics · Devices · 2024-04-15
  Class II
• 25-LHP-928, HeNe Laser System, 25 mW

  PACIFIC LASERTECH, LLC · Devices · 2024-03-01
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus

  Steris Corporation · Devices · 2024-06-13
  Class II
• NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

  NovaSignal Corp. · Devices · 2024-05-06
  Class II
• Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 24K Premium Lense, Distributed by Updream Inc.

  Ontact Inc · Devices · 2024-03-20
  Class II
• Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica

  Stryker Corporation · Devices · 2024-10-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

  Neurovision Medical Products Inc · Devices · 2024-07-01
  Class II
• WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Colonoscope, Model Number CF-Q180AL.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Cata

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, RE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small,

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Sys

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-02-06
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Cascade IOMAX Cortical Module, REF: 190296-200

  Cadwell Industries Inc · Devices · 2024-05-17
  Class II
• Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M

  Merit Medical Systems, Inc. · Devices · 2024-08-30
  Class II
• Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF

  Abbott Molecular, Inc. · Devices · 2024-09-12
  Class II
• Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

  HUMAN MED AG · Devices · 2024-10-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of device

  B. Braun Medical, Inc. · Devices · 2024-01-22
  Class II
• ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical

  Agfa Healthcare NV · Devices · 2024-09-06
  Class II
• 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Blood Pump Rotor, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-04-17
  Class II
• Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int

  Beckman Coulter, Inc. · Devices · 2024-11-26
  Class II
• Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS9

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)

  GE Medical Systems, LLC · Devices · 2024-11-25
  Class II
• LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

  LINK BIO CORP · Devices · 2024-06-27
  Class II
• BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machi

  Maquet Medical Systems USA · Devices · 2024-01-16
  Class II
• REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

  Orthofix Srl · Devices · 2024-09-24
  Class II
• MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemod

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent C

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic

  Philips North America Llc · Devices · 2024-05-03
  Class II
• DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and A

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• 8MM,PROGRASP FORCEPS,IS4000 REF 471093

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2024-07-22
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-263

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a

  Windstone Medical Packaging, Inc. · Devices · 2024-08-16
  Class II
• OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging sy

  GE OEC Medical Systems, Inc · Devices · 2024-11-21
  Class II
• Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Devices · 2024-01-15
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-05-16
  Class II
• Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparos

  Canadian Hospital Specialties Ltd. · Devices · 2024-06-11
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR

  MicroPort Orthopedics Inc. · Devices · 2024-10-29
  Class II
• MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the va

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

  Cook Biotech, Inc. · Devices · 2024-11-22
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-29
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• SynchroMed II Infusion Pump. Product Number: 8637-20

  Medtronic Neuromodulation · Devices · 2024-09-11
  Class II
• GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• GYROSCAN T5-NT, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

  Ossur H / F · Devices · 2024-03-25
  Class II
• GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• medex Arterial Kit 1/EA, Product Code REF MX7827

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Hand Pack, AKHD97C; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ

  Olympus Corporation of the Americas · Devices · 2024-09-13
  Class II
• Synapse PACS - Version 7.2.100

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-10
  Class II
• Intera 1.5T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures o

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Synapse PACS - Version 7.1.000

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-10
  Class II
• Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

  Hologic, Inc. · Devices · 2024-12-13
  Class II
• MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Thermalon Stye Compress, Item Number 24352

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359

  Philips North America Llc · Devices · 2024-05-03
  Class II
• N-LHP-928, HeNe Laser System, 35 mW

  PACIFIC LASERTECH, LLC · Devices · 2024-03-01
  Class II
• Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Softwar

  B Braun Medical Inc · Devices · 2024-06-14
  Class II
• Namic FLUID DELIVERY SET, REF 91300040

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-12
  Class II
• WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-30
  Class II
• MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-04-08
  Class II
• Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

  ConvaTec, Inc · Devices · 2024-01-17
  Class II
• SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

  Angiodynamics, Inc. · Devices · 2024-06-18
  Class II
• TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Produ

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with c

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2024-07-22
  Class II
• DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P

  Cardinal Health 200, LLC · Devices · 2024-05-29
  Class II
• Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d)

  Baxter Healthcare Corporation · Devices · 2024-02-28
  Class II
• The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Numb

  Maquet Cardiovascular, LLC · Devices · 2024-05-17
  Class II
• Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as

  Newport Corp · Devices · 2024-03-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Lab Kit, SKU DYLAB1018; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-

  Covidien LP · Devices · 2024-09-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

  Wondfo USA Co Ltd · Devices · 2024-04-22
  Class II
• Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a

  Stryker Corporation · Devices · 2024-10-04
  Class II
• Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

  Medivance Inc. · Devices · 2024-02-16
  Class II
• MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06

  DeRoyal Industries Inc · Devices · 2024-10-03
  Class II
• WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

  SIN SISTEMA DE IMPLANTE NACIONAL S.A · Devices · 2024-09-01
  Class II
• ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions

  Ion Beam Applications S.A. · Devices · 2024-07-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each

  Nihon Kohden America Inc · Devices · 2024-09-18
  Class II
• Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi

  Biomet, Inc. · Devices · 2024-03-13
  Class II
• Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

  Baxter Healthcare Corporation · Devices · 2024-10-11
  Class II
• Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.

  Medical Action Industries, Inc. 306 · Devices · 2024-01-15
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• dS Breast 16ch 1.5T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• SmartPath to dStream for 3.0T Model Number (REF): 782145

  Philips North America Llc · Devices · 2024-05-03
  Class II
• SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimula

  LivaNova USA, Inc. · Devices · 2024-12-12
  Class II
• RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of

  Becton Dickinson & Co. · Devices · 2024-08-01
  Class II
• Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only

  Abbott Medical · Devices · 2024-05-22
  Class II
• Intera 1.5T Achieva Nova, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model

  Cardinal Health 200, LLC · Devices · 2024-07-24
  Class II
• SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001629;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to

  Nihon Kohden America Inc · Devices · 2024-04-29
  Class II
• BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;

  CareFusion 303, Inc. · Devices · 2024-02-01
  Class II
• Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

  Covidien, LP · Devices · 2024-02-14
  Class II
• MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spin

  Medtronic Navigation, Inc. · Devices · 2024-08-22
  Class II
• Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT

  Avanos Medical, Inc. · Devices · 2024-05-31
  Class II
• Colonoscope, Model Number CF-H180AL.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

  Philips North America Llc · Devices · 2024-05-03
  Class II
• GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3)

  GE Medical Systems, LLC · Devices · 2024-11-25
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to p

  Baxter Healthcare Corporation · Devices · 2024-05-08
  Class II
• Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic

  PTW-FREIBURG · Devices · 2024-02-08
  Class II
• GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

  GE Vingmed Ultrasound As · Devices · 2024-05-02
  Class II
• Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of th

  Boston Scientific Corporation · Devices · 2024-07-18
  Class II
• Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC

  Trinity Sterile, Inc. · Devices · 2024-12-13
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in

  Ethicon, Inc. · Devices · 2024-05-10
  Class II
• Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

  New Medical Technologies Gmbh · Devices · 2024-12-19
  Class II
• MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) T

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The ir

  Johnson & Johnson Surgical Vision, Inc. · Devices · 2024-03-14
  Class II
• BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

  BioFire Diagnostics, LLC · Devices · 2024-06-10
  Class II
• HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t

  Beckman Coulter, Inc. · Devices · 2024-11-18
  Class II
• Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Inte

  NRT X-RAY A/S · Devices · 2024-04-17
  Class II
• 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG,

  Defibtech, LLC · Devices · 2024-10-14
  Class II
• PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so

  Ethicon, LLC · Devices · 2024-12-20
  Class II
• Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu

  Integra LifeSciences Corp. · Devices · 2024-04-17
  Class II
• IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x

  Alphatec Spine, Inc. · Devices · 2024-01-26
  Class II
• DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl

  Beckman Coulter Mishima K.K. · Devices · 2024-07-10
  Class II
• smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• DR 800. Digital Radiography X-ray System.

  Agfa N.V. · Devices · 2024-07-29
  Class II
• The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur

  Bard Peripheral Vascular Inc · Devices · 2024-09-04
  Class II
• Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-05-16
  Class II
• 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-9

  Thoratec Switzerland GMBH · Devices · 2024-05-22
  Class II
• Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-01-09
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona

  Siemens AG/Siemens Healthcare GmbH · Devices · 2024-06-26
  Class II
• TENSIVE Conductive Adhesive Gel, REF 016-401600

  Natus Neurology Inc · Devices · 2024-02-07
  Class II
• DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

  FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · Devices · 2024-06-26
  Class II
• Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Vaginal Delivery, ASDV25B; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-04-17
  Class II
• Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-07-15
  Class II
• Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Cepheid, Sample Collection Device, Part: 900-0370

  Cepheid · Devices · 2024-06-20
  Class II
• RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manu

  QUANTUM SURGICAL SAS · Devices · 2024-08-05
  Class II
• Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-q

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

  Caire, Inc. · Devices · 2024-10-04
  Class II
• Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur

  Stryker Corporation · Devices · 2024-10-04
  Class II
• Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

  Inspire Medical Systems Inc. · Devices · 2024-07-31
  Class II
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of

  Baxter Healthcare Corporation · Devices · 2024-06-03
  Class II
• Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for pr

  Olympus Corporation of the Americas · Devices · 2024-01-16
  Class II
• Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not

  ARROW INTERNATIONAL Inc. · Devices · 2024-07-26
  Class II
• BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

  Howmedica Osteonics Corp. · Devices · 2024-08-07
  Class II
• WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

  HeartSine Technologies Ltd · Devices · 2024-04-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ion Endoluminal System, REF: 380748-65

  Intuitive Surgical, Inc. · Devices · 2024-07-12
  Class II
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Ster

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs

  Ethicon, Inc. · Devices · 2024-05-10
  Class II
• Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

  Baxter Healthcare Corporation · Devices · 2024-10-02
  Class II
• Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-01-02
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2024-07-22
  Class II
• TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Intera 1.5T Achieva IT Nova, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

  Aerin Medical, Inc. · Devices · 2024-11-12
  Class II
• Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo

  Smith & Nephew, Inc. · Devices · 2024-10-15
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Ziehm Solo. Digital Mobile C-arm

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients

  Medtronic Navigation, Inc.-Littleton · Devices · 2024-04-26
  Class II
• FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

  Boston Scientific Corporation · Devices · 2024-10-28
  Class II
• BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 5810

  Beaver Visitec International, Inc. · Devices · 2024-02-02
  Class II
• Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Mammotrak Interventional Coil 3.0T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-02
  Class II
• IR Procedure Pack, CEAT19W; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• SlideView VS200 slide viewer,

  EVIDENT SCIENTIFIC INC · Devices · 2024-07-22
  Class II
• TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)

  Gauthier Biomedical, Inc. · Devices · 2024-11-11
  Class II
• ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products

  Microtek Medical Inc. · Devices · 2024-06-03
  Class II
• Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Descr

  Electro Medical Systems SA · Devices · 2024-03-13
  Class II
• Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interven

  Abbott Vascular Inc · Devices · 2024-11-06
  Class II
• Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratio

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• Intera 1.0T Omni/Stellar, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Custom Procedure Kit, REF: K12T-11077

  Merit Medical Systems, Inc. · Devices · 2024-08-12
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHRO

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001177;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

  Innomed, Inc. · Devices · 2024-03-07
  Class II
• Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: Th

  Hitachi America, Ltd., Particle Therapy Division · Devices · 2024-05-27
  Class II
• ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Desc

  Alcon Research LLC · Devices · 2024-04-22
  Class II
• Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-01-02
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001073;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set us

  BD SWITZERLAND SARL · Devices · 2024-04-18
  Class II
• ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G

  Siemens Medical Solutions USA, Inc. · Devices · 2024-02-23
  Class II
• SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimul

  LivaNova USA, Inc. · Devices · 2024-12-12
  Class II
• CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e

  GE Healthcare Finland Oy · Devices · 2024-04-05
  Class II
• SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Clean Catch Kit, SKU DYKM1833A; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• MEDLINE OPEN HEART, REF DYNJ904261B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• HAWK Advanced Hypothermia Management Set, Item Number: 59-320

  Safeguard US Operating LLC · Devices · 2024-08-27
  Class II
• Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01

  GE Healthcare Finland Oy · Devices · 2024-04-05
  Class II
• Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

  Abbott Medical · Devices · 2024-05-22
  Class II
• MEDLINE OPEN HEART PACK, REF DYNJ66216C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMM

  Beckman Coulter Inc. · Devices · 2024-07-31
  Class II
• AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as wel

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and man

  Topcon Medical Systems, Inc. · Devices · 2024-09-17
  Class II
• SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR0

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Synapse PACS - Version 7.2.000

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-10
  Class II
• TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Discrete photometric chemistry analyzer for clinical use.

  Beckman Coulter, Inc. · Devices · 2024-06-14
  Class II
• Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE

  NuVasive Specialized Orthopedics, Inc. · Devices · 2024-09-30
  Class II
• Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Ster

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 818392301013

  Sol-Millennium Medical Inc. · Devices · 2024-05-09
  Class II
• Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming

  Stryker Corporation · Devices · 2024-07-24
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surg

  American Surgical Company, LLC · Devices · 2024-09-18
  Class II
• Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Versi

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-05-07
  Class II
• Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult,

  Nihon Kohden America Inc · Devices · 2024-09-18
  Class II
• HAND PACK-Procedure Kit Catalog Number: WEHD16C

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e

  Siemens Healthcare Diagnostics Inc · Devices · 2024-05-17
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54

  Invacare Corporation · Devices · 2024-01-22
  Class II
• Nasal Sinus Pack, MTSN26B; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• See DocMan

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• GYROSCAN ACS-NT, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide pate

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

  Ossur H / F · Devices · 2024-03-25
  Class II
• 8MM,LONG TIP FORCEPS,IS4000 REF 471048

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide

  GE OEC Medical Systems, Inc · Devices · 2024-11-21
  Class II
• Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

  CareFusion 303, Inc. · Devices · 2024-08-15
  Class II
• BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/

  CareFusion 303, Inc. · Devices · 2024-05-13
  Class II
• Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 Th

  Medtronic Navigation, Inc. · Devices · 2024-12-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000168;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5

  Getinge Usa Sales Inc · Devices · 2024-05-29
  Class II
• Epix Universal Clip Applier, REF: CA500, STERILEEO

  Applied Medical Resources Corp · Devices · 2024-01-30
  Class II
• Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2

  Quidel Corporation · Devices · 2024-01-03
  Class II
• Achieva XR, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Pump 381 Pump Set (US); Product Code: 1000080;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Des

  Electro Medical Systems SA · Devices · 2024-03-13
  Class II
• SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

  Philips North America · Devices · 2024-01-03
  Class II
• TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Ziehm Solo FD. Interventional fluoroscopic x-ray system

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t

  Philips North America Llc · Devices · 2024-09-03
  Class II
• Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A

  Steris Corporation · Devices · 2024-06-13
  Class II
• Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Alinity hq Analyzer, REF: 09P68-01

  Abbott Laboratories · Devices · 2024-06-14
  Class II
• Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Stainless Steel Sims Uterine Sound, Part Number 64-601

  CooperSurgical, Inc. · Devices · 2024-07-31
  Class II
• Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Des

  CooperSurgical, Inc. · Devices · 2024-11-15
  Class II
• Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SC

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

  Smiths Medical ASD Inc. · Devices · 2024-07-18
  Class II
• Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administrati

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Ari

  Securitas Healthcare LLC · Devices · 2024-11-01
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Ster

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.

  Aesculap Inc · Devices · 2024-01-09
  Class II
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

  Beckman Coulter, Inc. · Devices · 2024-11-13
  Class II
• Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr

  Philips North America Llc · Devices · 2024-09-03
  Class II
• SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 1801

  Alcon Research, LLC · Devices · 2024-02-21
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-411

  Sklar Instruments · Devices · 2024-12-03
  Class II
• MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STER

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Softwar

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011L

  Sol-Millennium Medical Inc. · Devices · 2024-05-09
  Class II
• TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Vios Monitoring System Bedside Monitor Model BSM2050

  Murata Vios, Inc. · Devices · 2024-08-09
  Class II
• Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class II
• 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

  Baxter Healthcare Corporation · Devices · 2024-02-08
  Class II
• Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-09-04
  Class II
• APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

  Medartis Inc. · Devices · 2024-04-12
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC32

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Descripti

  Alcon Research LLC · Devices · 2024-11-13
  Class II
• Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216

  Philips North America Llc · Devices · 2024-11-20
  Class II
• IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restoration

  IVOCLAR VIVADENT AG · Devices · 2024-04-05
  Class II
• Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

  Intuitive Surgical, Inc. · Devices · 2024-08-21
  Class II
• Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601

  Cardinal Health 200, LLC · Devices · 2024-03-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000910;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (trache

  Sklar Instruments · Devices · 2024-12-03
  Class II
• prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5

  Centinel Spine, Inc. · Devices · 2024-07-18
  Class II
• SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Braun Thermoscan¿ PRO 6000 Ear Thermometer

  Baxter Healthcare Corporation · Devices · 2024-06-13
  Class II
• ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic ca

  Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · Devices · 2024-09-18
  Class II
• The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The dispos

  Mermaid Medical A/S · Devices · 2024-05-01
  Class II
• CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed

  Biosense Webster, Inc. · Devices · 2024-02-16
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Mammotrak Diagnostic Coil 1.5T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

  Encore Medical, LP · Devices · 2024-12-18
  Class II
• Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Sof

  Ultradent Products, Inc. · Devices · 2024-08-02
  Class II
• Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

  Spacelabs Healthcare, Inc. · Devices · 2024-11-25
  Class II
• Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

  Stryker GmbH · Devices · 2024-05-09
  Class II
• Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Num

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001546;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Ziehm Vision RFD. Interventional fluoroscopic x-ray system

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat

  Olympus Corporation of the Americas · Devices · 2024-09-13
  Class II
• Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.

  Smith & Nephew Inc. · Devices · 2024-08-12
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Ste

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in p

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus

  Steris Corporation · Devices · 2024-06-13
  Class II
• WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Ingenia 1.5T CX, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

  Ion Beam Applications S.A. · Devices · 2024-03-04
  Class II
• HAWK Warming Grid, Item Number: 59-300

  Safeguard US Operating LLC · Devices · 2024-08-27
  Class II
• Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife

  Alcon Research LLC · Devices · 2024-04-22
  Class II
• namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-12
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001521;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part N

  Wondfo USA Co Ltd · Devices · 2024-04-22
  Class II
• Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical

  Baxter Healthcare Corporation · Devices · 2024-06-04
  Class II
• Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp

  Healgen Scientific Llc · Devices · 2024-08-22
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236

  Sklar Instruments · Devices · 2024-12-03
  Class II
• COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-

  Medivance Inc. · Devices · 2024-06-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000266;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001118;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description:

  Nova Ortho-Med Inc · Devices · 2024-08-26
  Class II
• Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to conta

  The Metrix Company · Devices · 2024-10-09
  Class II
• DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D

  Cardinal Health 200, LLC · Devices · 2024-03-27
  Class II
• Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

  Abbott Medical · Devices · 2024-10-17
  Class II
• Diode Laser Hair Removal model: WLA-01

  WINGDERM ELECTRO-OPTICS LTD. · Devices · 2024-08-23
  Class II
• Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch

  Baxter Healthcare Corporation · Devices · 2024-02-22
  Class II
• Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

  LeMaitre Vascular, Inc. · Devices · 2024-04-17
  Class II
• Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch wi

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-01-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000568;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent

  SVS LLC · Devices · 2024-05-13
  Class II
• Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

  DeRoyal Industries Inc · Devices · 2024-10-03
  Class II
• vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a pe

  Boston Scientific Corporation · Devices · 2024-07-18
  Class II
• DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apher

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product D

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-05-17
  Class II
• KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b)

  Smiths Medical ASD Inc. · Devices · 2024-07-18
  Class II
• SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w

  Medtronic Neuromodulation · Devices · 2024-11-21
  Class II
• RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, s

  Bolton Medical Inc. · Devices · 2024-02-22
  Class II
• Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended

  Noah Medical · Devices · 2024-03-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-09-30
  Class II
• Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (O

  CUE HEALTH INC · Devices · 2024-05-24
  Class II
• Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• NEUROSIGN Disposable Stimulating Dissector, REF 5888-00

  Technomed Europe · Devices · 2024-07-25
  Class II
• GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001845;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• OMTech Desktop Laser Engraver

  Rygel Advanced Machines d/b/a Omtech Laser · Devices · 2024-06-07
  Class II
• WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

  Boston Scientific Neuromodulation Corporation · Devices · 2024-07-17
  Class II
• GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PU

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-01
  Class II
• Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medi

  Wondfo USA Co Ltd · Devices · 2024-04-22
  Class II
• ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and sta

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148;

  Wipro GE Healthcare Private Ltd. · Devices · 2024-08-09
  Class II
• Change Healthcare Cardiology Hemo software

  A L I Technologies Ltd · Devices · 2024-12-02
  Class II
• Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Des

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• PACEMAKER PACK, SLCV01J; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Neuro Vascular, ANKV91A; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001511;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicate

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabil

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch

  Baxter Healthcare Corporation · Devices · 2024-02-22
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-417

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Ingenia Elition S, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A P

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.

  Beckman Coulter Biomedical GmbH · Devices · 2024-07-17
  Class II
• Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

  Baxter Healthcare Corporation · Devices · 2024-10-11
  Class II
• AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-

  Exactech, Inc. · Devices · 2024-12-31
  Class II
• Thermalon Sinus Compress (French), Item Number 24332F

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b

  GE Healthcare · Devices · 2024-08-29
  Class II
• TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu

  Innovasis, Inc · Devices · 2024-08-14
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000603;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile

  Abbott Medical · Devices · 2024-10-17
  Class II
• Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo

  Zimmer, Inc. · Devices · 2024-09-17
  Class II
• WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial

  Sophysa S.A. · Devices · 2024-04-09
  Class II
• ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Desc

  Alcon Research LLC · Devices · 2024-04-22
  Class II
• STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

  B Braun Medical Inc · Devices · 2024-05-17
  Class II
• mint Lesion, Software Versions: 3.9.0 through 3.9.5.

  Mint Medical GmbH · Devices · 2024-11-15
  Class II
• Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1

  Sol-Millennium Medical Inc. · Devices · 2024-05-09
  Class II
• SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

  Hologic, Inc. · Devices · 2024-11-08
  Class II
• MICRO-X Rover Mobile X-ray System, # MXU-RV19

  Micro-X Ltd. · Devices · 2024-10-23
  Class II
• System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-08-22
  Class II
• Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000056;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an

  Qiagen Sciences LLC · Devices · 2024-03-04
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use

  Ethicon, Inc. · Devices · 2024-05-10
  Class II
• MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

  Datascope Corp. · Devices · 2024-09-17
  Class II
• BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001876;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medtronic DLP Vessel Cannula, Model Number REF 30000

  Medtronic Perfusion Systems · Devices · 2024-02-07
  Class II
• Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-03-13
  Class II
• Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5

  Getinge Usa Sales Inc · Devices · 2024-05-29
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicat

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-235

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medtronic DLP Coronary Ostial Cannulae, Model Number 30050

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tu

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584587;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syrin

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Synapse PACS - Version 7.1.000US

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-10
  Class II
• Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On

  MICROVENTION INC. · Devices · 2024-12-02
  Class II
• UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:

  Howmedica Osteonics Corp. · Devices · 2024-06-19
  Class II
• MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o

  Philips North America Llc · Devices · 2024-09-03
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

  Merit Medical Systems, Inc. · Devices · 2024-03-14
  Class II
• Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog

  Cardinal Health 200, LLC · Devices · 2024-05-29
  Class II
• Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decort

  Stryker Corporation · Devices · 2024-07-24
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• 48" Lead Wires, Replacement Part Number: 1067724-4

  EBI, LLC · Devices · 2024-03-22
  Class II
• QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu

  Qiagen Sciences LLC · Devices · 2024-06-03
  Class II
• HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-02-06
  Class II
• Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• CRANIOTOMY PACK, Pack Number DYNJ46552O

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-18
  Class II
• See RES Description

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-04-17
  Class II
• RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Nu

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Numb

  3B Medical, Inc. · Devices · 2024-11-27
  Class II
• Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

  Medtronic Perfusion Systems · Devices · 2024-07-09
  Class II
• Thermalon Back Wrap, Item Number 24312

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

  Zimmer, Inc. · Devices · 2024-03-28
  Class II
• Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

  Randox Laboratories Ltd. · Devices · 2024-01-31
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001048;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or sp

  Philips North America Llc · Devices · 2024-09-03
  Class II
• BD PCR Cartridges used with MAX System. Model Number: 437519

  Becton Dickinson & Co. · Devices · 2024-12-19
  Class II
• BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 a

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

  Medtronic Perfusion Systems · Devices · 2024-12-12
  Class II
• basixSKY Inflation Device, REF: SKY1802

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention an

  Baxter Healthcare Corporation · Devices · 2024-03-05
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• Impella CP Smart Assist Set; Product Code: 1000402;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001373;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conn

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

  Alcon Research LLC · Devices · 2024-08-08
  Class II
• WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

  NOA Medical Industries Inc · Devices · 2024-11-05
  Class II
• Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software

  Lucid Diagnostics, Inc. · Devices · 2024-04-24
  Class II
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/i

  ConvaTec, Inc · Devices · 2024-02-27
  Class II
• Atellica IM Erythropoietin (EPO) Assay (100 Test)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-01-24
  Class II
• MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

  CORENTEC CO., LTD · Devices · 2024-03-29
  Class II
• STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Steril

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s

  Tornier, Inc · Devices · 2024-08-29
  Class II
• Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Compone

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-05-22
  Class II
• GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Sil

  Covidien LP · Devices · 2024-03-15
  Class II
• VariSoft Infusion Set, Single Use.

  Unomedical A/S · Devices · 2024-07-23
  Class II
• Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

  Masimo Corporation · Devices · 2024-02-15
  Class II
• Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The

  Beckman Coulter, Inc. · Devices · 2024-09-05
  Class II
• Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

  Ossur H / F · Devices · 2024-03-25
  Class II
• Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and sta

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in

  Windstone Medical Packaging, Inc. · Devices · 2024-08-16
  Class II
• Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE T

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET

  GE Medical Systems Information Technologies Inc · Devices · 2024-04-09
  Class II
• OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

  Exactech, Inc. · Devices · 2024-04-18
  Class II
• BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically s

  Becton Dickinson & Co. · Devices · 2024-08-01
  Class II
• Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript

  O&M HALYARD, INC. · Devices · 2024-11-26
  Class II
• GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Trevo ProVue, Catalog: 90184

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001157;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7

  Baxter Healthcare Corporation · Devices · 2024-09-18
  Class II
• Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

  Randox Laboratories Ltd. · Devices · 2024-01-31
  Class II
• 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-04-17
  Class II
• GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1

  CareFusion 303, Inc. · Devices · 2024-05-13
  Class II
• HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co

  Mindray DS USA, Inc. dba Mindray North America · Devices · 2024-07-22
  Class II
• Atellica CI Analyzer. Catalog Numbers: 10947347.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001774;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the u

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Steril

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF

  Merit Medical Systems, Inc. · Devices · 2024-08-30
  Class II
• Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca

  Cook Incorporated · Devices · 2024-03-01
  Class II
• FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum

  Princeton Biomeditech Corp · Devices · 2024-08-23
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A,

  Sklar Instruments · Devices · 2024-12-03
  Class II
• SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-02-06
  Class II
• BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio

  BioFire Diagnostics, LLC · Devices · 2024-06-19
  Class II
• Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

  Ad-Tech Medical Instrument Corporation · Devices · 2024-09-19
  Class II
• Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF

  Abbott Molecular, Inc. · Devices · 2024-09-12
  Class II
• MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hep

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-12-23
  Class II
• Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile

  GE Medical Systems, LLC · Devices · 2024-12-06
  Class II
• LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the Li

  XENEX Disinfection Services Inc. · Devices · 2024-03-18
  Class II
• BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 an

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

  SURGICAL SPECIALTIES · Devices · 2024-03-26
  Class II
• Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformi

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-02-15
  Class II
• VITROS XT 7600 Integrated System, Catalog No. 6844461

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• TourniKwik Tourniquet Set (CFN 79012)

  Medtronic Perfusion Systems · Devices · 2024-05-16
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000477;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

  St. Jude Medical · Devices · 2024-04-30
  Class II
• VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

  Accriva Diagnostics, Inc. · Devices · 2024-12-02
  Class II
• Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the

  SIGHT DIAGNOSTICS LTD · Devices · 2024-05-13
  Class II
• MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8

  Advanced Medical Solutions Ltd. · Devices · 2024-10-01
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Mode

  Carwild Corporation · Devices · 2024-10-22
  Class II
• Trevo Trak 21 Microcatheter, Catalog: 90338

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Centurion STERILE #16 RUBBER BAND, Product Code EB16

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps a

  MicroSurgical Technology Inc · Devices · 2024-09-17
  Class II
• 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65

  TriMed Inc. · Devices · 2024-03-19
  Class II
• Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi

  Outset Medical, Inc. · Devices · 2024-08-01
  Class II
• AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

  Hollister Incorporated · Devices · 2024-12-23
  Class II
• SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Mode

  Philips North America Llc · Devices · 2024-05-03
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999;

  GE Healthcare (China) Co., Ltd. · Devices · 2024-07-12
  Class II
• Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDO

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475

  Cardinal Health 200, LLC · Devices · 2024-03-27
  Class II
• Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

  Olympus Corporation of the Americas · Devices · 2024-08-21
  Class II
• iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

  Atrium Medical Corporation · Devices · 2024-09-09
  Class II
• OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02

  Exactech, Inc. · Devices · 2024-04-18
  Class II
• SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with

  Medtronic Neuromodulation · Devices · 2024-11-21
  Class II
• AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

  Hollister Incorporated · Devices · 2024-12-23
  Class II
• EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad

  Elucent Medical Inc · Devices · 2024-11-18
  Class II
• Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-01-09
  Class II
• Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch

  Baxter Healthcare Corporation · Devices · 2024-02-22
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syring

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with ho

  W.L. Gore & Associates, Inc. · Devices · 2024-01-19
  Class II
• Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.

  Philips North America · Devices · 2024-01-03
  Class II
• Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

  Covidien, LP · Devices · 2024-02-14
  Class II
• Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v

  Cook Incorporated · Devices · 2024-03-01
  Class II
• smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

  Smiths Medical ASD, Inc. · Devices · 2024-10-28
  Class II
• CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a

  Integra LifeSciences Corp. · Devices · 2024-05-29
  Class II
• Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225

  Baxter Healthcare Corporation · Devices · 2024-02-28
  Class II
• Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hyp

  Augustine Temperature Management, LLC · Devices · 2024-12-16
  Class II
• Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46

  Trinity Sterile, Inc. · Devices · 2024-12-13
  Class II
• Duravent Silicone Ventilation Tube. Model Number: 240075.

  Olympus Corporation of the Americas · Devices · 2024-11-19
  Class II
• Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

  Voco GmbH · Devices · 2024-01-25
  Class II
• BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• Thermalon Sinus Compress, Item Number 24332

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-12-23
  Class II
• BD Pyxis CII Safe ES, REF: 1116-00

  CareFusion 303, Inc. · Devices · 2024-11-14
  Class II
• DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.

  Aesculap Inc · Devices · 2024-01-09
  Class II
• 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

  Zimmer Surgical Inc · Devices · 2024-01-02
  Class II
• ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicato

  Trinity Sterile, Inc. · Devices · 2024-12-13
  Class II
• I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

  In2Bones, SAS · Devices · 2024-01-26
  Class II
• MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS9

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Colonoscope, Model Number PCF-H180AL.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• MEDLINE HEART CABG CDS, REF CDS983376R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001212;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001526;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a dia

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001423;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) adm

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Colonoscope, Model Number CF-HQ190L.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-02-28
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001176;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

  Abbott Laboratories · Devices · 2024-02-21
  Class II
• Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2

  Baxter Healthcare Corporation · Devices · 2024-06-14
  Class II
• ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• impression coping, repositionable, short, screw-retained, PF 4.0

  Thommen Medical AG · Devices · 2024-01-24
  Class II
• Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only

  Karl Storz Endoscopy · Devices · 2024-02-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001693;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use on

  Med Michigan Holding Llc · Devices · 2024-11-19
  Class II
• IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

  IVOCLAR VIVADENT AG · Devices · 2024-04-05
  Class II
• 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS98

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

  Oxoid Limited · Devices · 2024-12-23
  Class II
• Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in

  Windstone Medical Packaging, Inc. · Devices · 2024-08-16
  Class II
• KNEE SCOPE Procedure tray Catalog Number: COKN48L

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.

  Siemens Medical Solutions USA, Inc. · Devices · 2024-08-15
  Class II
• 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNEL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786

  GE Healthcare Finland Oy · Devices · 2024-04-05
  Class II
• Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

  First Source Inc · Devices · 2024-05-09
  Class II
• Chromophare Surgical Light System , REF CH00000001

  Stryker Communications · Devices · 2024-02-08
  Class II
• Embrace Drill Tower, Wedged (25mm)

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-01-29
  Class II
• Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO

  Sklar Instruments · Devices · 2024-12-03
  Class II
• McKesson Cardiology Hemo software

  A L I Technologies Ltd · Devices · 2024-12-02
  Class II
• Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

  Covidien, LLC · Devices · 2024-04-25
  Class II
• SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

  Angiodynamics, Inc. · Devices · 2024-11-25
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832

  3M Company - Health Care Business · Devices · 2024-11-22
  Class II
• Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT658

  Cardinal Health 200, LLC · Devices · 2024-11-01
  Class II
• Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-05-02
  Class II
• OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,

  IsoTis OrthoBiologics, Inc. · Devices · 2024-11-27
  Class II
• AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

  Accriva Diagnostics, Inc. · Devices · 2024-09-27
  Class II
• WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038

  Olympus Corporation of the Americas · Devices · 2024-09-11
  Class II
• SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in pr

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

  GE Healthcare · Devices · 2024-08-05
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000757;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.

  Philips North America · Devices · 2024-01-03
  Class II
• GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed,

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M

  AURIS HEALTH INC · Devices · 2024-08-02
  Class II
• Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4

  ConvaTec, Inc · Devices · 2024-02-19
  Class II
• Cascade IOMAX Cortical Module, REF: 190296-200

  Cadwell Industries Inc · Devices · 2024-04-23
  Class II
• Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• X3 TRIATHLON CS INSERT NO 6 10 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to he

  Advanced Medical Solutions Ltd. · Devices · 2024-10-01
  Class II
• Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo

  Philips North America Llc · Devices · 2024-04-22
  Class II
• SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in pro

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSER

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Aeos Robotic Digital Microscope, Product Code: PV010

  Aesculap Inc · Devices · 2024-05-13
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 5

  Safeguard US Operating LLC · Devices · 2024-08-27
  Class II
• Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

  Stryker Orthopaedics · Devices · 2024-04-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001314;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numb

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-04-23
  Class II
• Access Total T4, REF 33800, IVD, thyroxine reagent assay.

  Beckman Coulter, Inc. · Devices · 2024-02-08
  Class II
• OptiCross Coronary Imaging Catheter, REF H749518080120

  Boston Scientific Corporation · Devices · 2024-03-05
  Class II
• Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syrin

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 9

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description

  B Braun Medical Inc · Devices · 2024-06-14
  Class II
• Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-08-08
  Class II
• MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 M

  Trinity Sterile, Inc. · Devices · 2024-12-13
  Class II
• CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-04
  Class II
• TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants dur

  Synthes (USA) Products LLC · Devices · 2024-04-25
  Class II
• Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

  Tornier, Inc · Devices · 2024-01-03
  Class II
• Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• VITROS 5600 Integrated System (New and Refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-22
  Class II
• Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif

  Ortho-Clinical Diagnostics, INc. · Devices · 2024-12-19
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 34

  Baxter Healthcare Corporation · Devices · 2024-03-26
  Class II
• OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is de

  GE OEC Medical Systems, Inc · Devices · 2024-11-21
  Class II
• Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS78

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified

  Ortho-Clinical Diagnostics, INc. · Devices · 2024-12-19
  Class II
• DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

  DRG International, Inc. · Devices · 2024-10-07
  Class II
• EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

  Encore Medical, LP · Devices · 2024-12-10
  Class II
• Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-40

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP

  Qualigen Inc · Devices · 2024-08-26
  Class II
• Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R

  Accuray Incorporated · Devices · 2024-12-23
  Class II
• Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w

  CooperVision, Inc. · Devices · 2024-08-29
  Class II
• (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-15
  Class II
• Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti

  Noah Medical · Devices · 2024-10-28
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

  Smith & Nephew Inc. · Devices · 2024-10-29
  Class II
• BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-01-02
  Class II
• BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

  W.L. Gore & Associates, Inc. · Devices · 2024-07-03
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324

  CareFusion 303, Inc. · Devices · 2024-11-14
  Class II
• MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS9

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes wi

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

  Covidien, LP · Devices · 2024-02-28
  Class II
• Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Descr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Alaris PCA Module Model 8120, a modular infusion pump and monitoring system

  CareFusion 303, Inc. · Devices · 2024-08-15
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• smiths medical portex, Y' PIECE 15MM, REF 100/276/000

  Smiths Medical ASD Inc. · Devices · 2024-07-18
  Class II
• mint Lesion, Software Versions: 3.10.0 and 3.10.1.

  Mint Medical GmbH · Devices · 2024-11-15
  Class II
• Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Cat

  Ambu Inc. · Devices · 2024-09-16
  Class II
• Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ223

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584742;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297

  MICROVENTION INC. · Devices · 2024-12-11
  Class II
• ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

  Mirion Technologies (Capintec), Inc. · Devices · 2024-04-22
  Class II
• Stryker Blueprint Software, Catalog #BPUE001.

  Tornier S.A.S. · Devices · 2024-04-16
  Class II
• OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure

  Advanced Instruments, LLC · Devices · 2024-03-11
  Class II
• Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

  Beckman Coulter, Inc. · Devices · 2024-04-18
  Class II
• Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pa

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to conta

  The Metrix Company · Devices · 2024-10-09
  Class II
• LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

  CORENTEC CO., LTD · Devices · 2024-03-29
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001691;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fis

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL

  Covidien, LP · Devices · 2024-02-28
  Class II
• Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene

  Agfa N.V. · Devices · 2024-02-23
  Class II
• FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-

  SPINEART SA · Devices · 2024-03-15
  Class II
• Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended

  Zyno Medical LLC · Devices · 2024-10-18
  Class II
• Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Me

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-29
  Class II
• DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hem

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number:

  Howmedica Osteonics Corp. · Devices · 2024-06-19
  Class II
• Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) ad

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Medline Convenience kits labeled as: SCS-LF, DYNJ902314D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

  Cook Medical Incorporated · Devices · 2024-04-01
  Class II
• ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• 8MM,CADIERE FORCEPS,IS4000 REF 471049

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-03
  Class II
• natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252

  Natus Neurology Inc · Devices · 2024-02-07
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syrin

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultraso

  Siemens Medical Solutions USA, Inc. · Devices · 2024-08-15
  Class II
• VITROS Performance Verifier I

  Ortho-Clinical Diagnostics · Devices · 2024-02-27
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-30
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

  Philips North America Llc · Devices · 2024-11-16
  Class II
• Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-

  Maquet Medical Systems USA · Devices · 2024-01-16
  Class II
• Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Pak

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

  Olympus Corporation of the Americas · Devices · 2024-01-29
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-

  GE Healthcare Finland Oy · Devices · 2024-04-05
  Class II
• DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

  Stryker Orthopaedics · Devices · 2024-04-15
  Class II
• Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialy

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• BD Pyxis" Anesthesia Station ES, REF: 327

  CareFusion 303, Inc. · Devices · 2024-04-15
  Class II
• WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Descri

  EYE COMFORT CARE LLC · Devices · 2024-02-08
  Class II
• The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and p

  Stryker Neurovascular · Devices · 2024-04-18
  Class II
• The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available

  Stryker Corporation · Devices · 2024-06-03
  Class II
• NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

  Luminex Molecular Diagnostics Inc · Devices · 2024-09-05
  Class II
• Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

  Ethicon, Inc. · Devices · 2024-09-25
  Class II
• ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in pro

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 an

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractur

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as

  Landauer · Devices · 2024-02-08
  Class II
• Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Mo

  Medtronic Neuromodulation · Devices · 2024-06-17
  Class II
• Identity Imprint PS Tibial Tray Size 4: Lot 540287

  Conformis, Inc. · Devices · 2024-03-11
  Class II
• Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

  Zoe Medical Incorporated · Devices · 2024-08-13
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

  DeRoyal Industries Inc · Devices · 2024-10-03
  Class II
• Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connect

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to

  Cook Incorporated · Devices · 2024-03-01
  Class II
• FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

  Ossur H / F · Devices · 2024-03-25
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

  Ethicon, LLC · Devices · 2024-12-20
  Class II
• Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-06-04
  Class II
• Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

  Cartiva, Inc · Devices · 2024-10-31
  Class II
• The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming

  Abbott Medical · Devices · 2024-11-21
  Class II
• MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504),

  Canon Medical System, USA, INC. · Devices · 2024-05-10
  Class II
• ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002063;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Power Express, REF B90918

  Beckman Coulter Biomedical GmbH · Devices · 2024-07-17
  Class II
• Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

  Howmedica Osteonics Corp. · Devices · 2024-05-23
  Class II
• Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

  Smiths Medical ASD Inc. · Devices · 2024-07-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001305;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• The Oncology Essentials Package of the Spectral CT imaging system.

  Philips North America Llc · Devices · 2024-03-29
  Class II
• Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourn

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: P

  B Braun Medical Inc · Devices · 2024-06-14
  Class II
• ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stab

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f

  Baxter Healthcare Corporation · Devices · 2024-03-11
  Class II
• BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate

  Philips North America Llc · Devices · 2024-06-28
  Class II
• (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue

  Artivion, Inc · Devices · 2024-05-28
  Class II
• Thermalon Neck Wrap, Item Number 24322

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• dS Breast 7ch 3.0T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer

  Ortho-Clinical Diagnostics, INc. · Devices · 2024-12-19
  Class II
• cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for

  Roche Diagnostics Operations, Inc. · Devices · 2024-10-17
  Class II
• Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system

  CareFusion 303, Inc. · Devices · 2024-08-15
  Class II
• MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-04-11
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001123;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-10-28
  Class II
• Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier

  Verathon, Inc. · Devices · 2024-04-29
  Class II
• ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-26
  Class II
• Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) admini

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC L

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), R

  Nalu Medical, Inc. · Devices · 2024-06-03
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Steril

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,

  Masimo Corporation · Devices · 2024-02-15
  Class II
• HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc

  Philips North America Llc · Devices · 2024-05-03
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

  Nipro Renal Soultions USA, Corporation · Devices · 2024-11-22
  Class II
• MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-02-06
  Class II
• Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

  Cardinal Health 200, LLC · Devices · 2024-11-01
  Class II
• Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version:

  Ultradent Products, Inc. · Devices · 2024-08-02
  Class II
• ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD,

  GE Healthcare GmbH · Devices · 2024-08-08
  Class II
• Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile

  Abbott Medical · Devices · 2024-10-17
  Class II
• ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

  NovaSignal Corp. · Devices · 2024-05-06
  Class II
• BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lo

  Embecta Corp. · Devices · 2024-06-18
  Class II
• HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

  Karl Storz Endoscopy · Devices · 2024-04-01
  Class II
• Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient li

  Human Care Hc Sweden Ab · Devices · 2024-02-23
  Class II
• Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC7

  Augustine Temperature Management, LLC · Devices · 2024-12-04
  Class II
• MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)

  Integra LifeSciences Corp. · Devices · 2024-09-13
  Class II
• MRI system: Vantage Elan, Model: MRT-2020

  Canon Medical System, USA, INC. · Devices · 2024-01-29
  Class II
• The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced t

  Spineology, Inc. · Devices · 2024-09-16
  Class II
• Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in

  Windstone Medical Packaging, Inc. · Devices · 2024-08-16
  Class II
• Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT

  Medtronic Inc. · Devices · 2024-07-11
  Class II
• SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in prote

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001795;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)

  Cypress Medical Products LLC · Devices · 2024-07-24
  Class II
• Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description:

  Nova Ortho-Med Inc · Devices · 2024-08-26
  Class II
• Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypo

  Augustine Temperature Management, LLC · Devices · 2024-12-16
  Class II
• Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu

  Stryker Corporation · Devices · 2024-10-04
  Class II
• Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Devices · 2024-01-15
  Class II
• Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Mod

  Olympus Corporation of the Americas · Devices · 2024-01-16
  Class II
• Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

  Abbott Diagnostics Technologies AS · Devices · 2024-06-17
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicat

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

  CareFusion 303, Inc. · Devices · 2024-05-21
  Class II
• Ingenia Elition X, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Enterprise 1.5T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin Ma

  Pro-Dex Inc · Devices · 2024-09-23
  Class II
• Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t

  Cook Incorporated · Devices · 2024-03-01
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000479;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• See RES description

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

  FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · Devices · 2024-06-26
  Class II
• DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straum

  Preat Corp · Devices · 2024-06-25
  Class II
• SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Mo

  ImaCor Inc. · Devices · 2024-09-16
  Class II
• Paracentesis Thoracente, SLPT76H; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

  Aesculap Inc · Devices · 2024-01-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW &

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in prote

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit

  Applied Medical Resources Corp · Devices · 2024-01-30
  Class II
• Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• GE Proteus XR/A radiographic system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-10-24
  Class II
• LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

  Waldemar Link GmbH & Co. KG (Corp. Hq.) · Devices · 2024-09-11
  Class II
• Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes w

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001706;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be u

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-03
  Class II
• Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. M

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• Alinity m System, Part Number: 08N53-002

  Abbott Molecular, Inc. · Devices · 2024-03-20
  Class II
• Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic

  Microcare Medical · Devices · 2024-08-29
  Class II
• Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resi

  Securitas Healthcare LLC · Devices · 2024-06-20
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001411;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001753;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Cath Lab Pack, CECL02P; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65

  TriMed Inc. · Devices · 2024-03-19
  Class II
• PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi

  Fisher & Paykel Healthcare, Ltd. · Devices · 2024-08-07
  Class II
• Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Achieva 1.5T Initial system Model Number (REF): 781178

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

  BioFire Diagnostics, LLC · Devices · 2024-06-10
  Class II
• Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReS

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective c

  Boston Scientific Corporation · Devices · 2024-06-12
  Class II
• FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

  CooperSurgical, Inc. · Devices · 2024-02-16
  Class II
• Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-26
  Class II
• Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-

  Cook Incorporated · Devices · 2024-10-08
  Class II
• Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

  Fisher & Paykel Healthcare, Ltd. · Devices · 2024-04-02
  Class II
• DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate

  Philips North America Llc · Devices · 2024-06-28
  Class II
• Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a

  Cook Incorporated · Devices · 2024-03-01
  Class II
• MR 7700, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Access Substrate, REF 81906, For use with the Access Immunoassay Systems

  Beckman Coulter, Inc. · Devices · 2024-02-07
  Class II
• BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES

  CareFusion 303, Inc. · Devices · 2024-05-02
  Class II
• Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System I

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the d

  Stryker Neurovascular · Devices · 2024-04-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000305;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF

  SEDECAL SA · Devices · 2024-01-22
  Class II
• Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-04-10
  Class II
• PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardi

  Ethicon, Inc. · Devices · 2024-05-10
  Class II
• Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• EasyPoint Needle, 25G x 5/8", REF: 82091

  Retractable Technologies, Inc. · Devices · 2024-02-05
  Class II
• ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile

  Abbott Medical · Devices · 2024-10-17
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001394;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion ac

  EBI, LLC · Devices · 2024-03-22
  Class II
• Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products t

  Microtek Medical Inc. · Devices · 2024-06-03
  Class II
• Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur

  Howmedica Osteonics Corp. · Devices · 2024-09-04
  Class II
• 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Achieva XR. Model (REF) Numbers 781153, 781253.

  Philips North America · Devices · 2024-01-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000711;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-224

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy S

  Noah Medical · Devices · 2024-10-25
  Class II
• IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients wi

  Ion Beam Applications S.A. · Devices · 2024-05-10
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system

  CareFusion 303, Inc. · Devices · 2024-07-09
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• American Contract Systems Spine Pack convenience kit

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy

  B-K Medical A/S · Devices · 2024-09-04
  Class II
• prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5

  Centinel Spine, Inc. · Devices · 2024-07-18
  Class II
• DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01

  FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · Devices · 2024-06-26
  Class II
• VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

  Greiner Bio-One North America, Inc. · Devices · 2024-05-14
  Class II
• Refer to RES or lead review memo for complete list of affected reference/catalog numbers

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

  Allergan Sales, LLC · Devices · 2024-03-14
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001382;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

  Abbott Medical · Devices · 2024-05-16
  Class II
• IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

  Angiodynamics, Inc. · Devices · 2024-05-21
  Class II
• Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• VITROS XT7600 Integrated System

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-22
  Class II
• remel BactiDrop Acridine Orange, REF 21502, 50 per package.

  Remel, Inc · Devices · 2024-09-20
  Class II
• Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

  Draeger Medical Systems, Inc. · Devices · 2024-05-13
  Class II
• Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001527;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001637;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Devices · 2024-09-06
  Class II
• Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-01
  Class II
• Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

  W&H DENTALWERK BUERMOOS GMBH · Devices · 2024-01-16
  Class II
• MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Baxter Operating Table TruSystem 7000 V, Product code REF 1841050

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) OR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-08-15
  Class II
• ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabi

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• GYROSCAN T5, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-07-03
  Class II
• Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) A

  ev3 Inc · Devices · 2024-12-10
  Class II
• BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet

  CareFusion 303, Inc. · Devices · 2024-04-15
  Class II
• ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• UA KIT, SKU DYKM1690A; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brai

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBI

  Baxter Healthcare Corporation · Devices · 2024-02-28
  Class II
• MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-09-04
  Class II
• Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The

  Hitachi America, Ltd., Particle Therapy Division · Devices · 2024-05-27
  Class II
• GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2

  GE Healthcare · Devices · 2024-10-03
  Class II
• RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.

  Wishbone Medical, Inc. · Devices · 2024-04-05
  Class II
• Intera Achieva 1.5T Pulsar, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.

  EMD Millipore Corporation · Devices · 2024-01-26
  Class II
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338

  QUIDEL ORTHO · Devices · 2024-12-05
  Class II
• Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product D

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-05-17
  Class II
• Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo

  Randox Laboratories, Limited · Devices · 2024-12-20
  Class II
• BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.

  Carwild Corporation · Devices · 2024-10-22
  Class II
• Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe t

  Mirion Technologies (Capintec), Inc. · Devices · 2024-04-22
  Class II
• TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such

  Abbott Vascular Inc · Devices · 2024-11-06
  Class II
• AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

  Hollister Incorporated · Devices · 2024-12-23
  Class II
• 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution

  Stryker Leibinger GmbH & Co. KG · Devices · 2024-04-04
  Class II
• POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur

  Olympus Corporation of the Americas · Devices · 2024-03-07
  Class II
• Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative meas

  QUIDELORTHO · Devices · 2024-04-09
  Class II
• OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

  IMPULSE DYNAMICS (USA) INC · Devices · 2024-01-05
  Class II
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

  Baxter Healthcare Corporation · Devices · 2024-11-19
  Class II
• Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-09-04
  Class II
• Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Soltive Premium SuperPulsed Laser System, Model TFL-PLS

  Olympus Corporation of the Americas · Devices · 2024-05-31
  Class II
• Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

  Preat Corp · Devices · 2024-02-09
  Class II
• Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

  Siemens Medical Solutions USA, Inc. · Devices · 2024-08-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000567;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

  Cook Biotech, Inc. · Devices · 2024-11-22
  Class II
• Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Achieva 3.0TX for PET, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im

  Philips North America Llc · Devices · 2024-09-03
  Class II
• KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide paten

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive dis

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICAT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 c

  Randox Laboratories Ltd. · Devices · 2024-03-05
  Class II
• Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only

  Karl Storz Endoscopy · Devices · 2024-02-27
  Class II
• Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,

  Beckman Coulter, Inc. · Devices · 2024-03-05
  Class II
• ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

  Beckman Coulter, Inc. · Devices · 2024-01-03
  Class II
• The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro

  Stryker Neurovascular · Devices · 2024-04-18
  Class II
• SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

  Olympus Corporation of the Americas · Devices · 2024-01-29
  Class II
• Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

  Karl Storz Endoscopy · Devices · 2024-10-21
  Class II
• GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001713;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ziehm Vision system, x-ray, tomography, computed.

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes w

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softw

  Blue Belt Technologies, Inc · Devices · 2024-05-07
  Class II
• Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingiv

  Dental EZ Group Star Dental Division · Devices · 2024-05-30
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000749;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

  Covidien · Devices · 2024-02-21
  Class II
• Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Con

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000426;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" H

  St. Jude Medical · Devices · 2024-11-06
  Class II
• GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

  Maquet Cardiovascular, LLC · Devices · 2024-10-16
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

  Centers For Disease Control and Prevention · Devices · 2024-04-26
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an int

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he

  CareFusion 303, Inc. · Devices · 2024-02-23
  Class II
• VITROS XT 3400 Chemistry System, Catalog No. 6844458

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from c

  Becton Dickinson & Co. · Devices · 2024-07-18
  Class II
• ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment

  ICU Medical, Inc. · Devices · 2024-11-06
  Class II
• Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001304;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CA

  Smiths Medical ASD, Inc. · Devices · 2024-06-26
  Class II
• RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may

  Smith & Nephew Medical, Ltd. · Devices · 2024-10-02
  Class II
• Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch record

  Spacelabs Healthcare, Ltd. · Devices · 2024-11-25
  Class II
• Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

  Cook Biotech, Inc. · Devices · 2024-11-22
  Class II
• FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v

  Olympus Corporation of the Americas · Devices · 2024-08-13
  Class II
• Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Pos

  Canon Medical System, USA, INC. · Devices · 2024-09-17
  Class II
• Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

  In2Bones, SAS · Devices · 2024-01-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000781;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ST SENSE Breast Dx Coil

  Philips North America Llc · Devices · 2024-11-04
  Class II
• ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version V

  Siemens Medical Solutions USA, Inc. · Devices · 2024-02-23
  Class II
• DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an

  KCI USA, INC. · Devices · 2024-11-05
  Class II
• Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117

  O&M HALYARD, INC. · Devices · 2024-11-08
  Class II
• Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNC

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi

  Stryker Corporation · Devices · 2024-10-04
  Class II
• Medtronic Clearview Blower/Mister, Model Number 22120

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Intera CV, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Colonoscope, Model Number PCF-Q180AL.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 23164

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,

  Stryker Sustainability Solutions · Devices · 2024-05-10
  Class II
• VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligat

  Ethicon, Inc. · Devices · 2024-05-10
  Class II
• Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8

  Baxter Healthcare Corporation · Devices · 2024-07-17
  Class II
• Endovascular AAA Pack, ESED52B; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

  Abbott Vascular Inc · Devices · 2024-11-06
  Class II
• Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass

  B. Braun Medical, Inc. · Devices · 2024-01-22
  Class II
• Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

  Andover Healthcare Inc. · Devices · 2024-04-02
  Class II
• medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,

  Masimo Corporation · Devices · 2024-02-15
  Class II
• Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

  Covidien · Devices · 2024-01-09
  Class II
• Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR0

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In

  HF Acquisition Co LLC · Devices · 2024-12-11
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584643;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

  Covidien · Devices · 2024-07-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584785;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interacti

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use i

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous de

  Preat Corp · Devices · 2024-04-10
  Class II
• IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients wit

  Ion Beam Applications S.A. · Devices · 2024-07-10
  Class II
• Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• BD Pyxis MedStation ES, REF: 323

  CareFusion 303, Inc. · Devices · 2024-11-14
  Class II
• Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ven

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-15
  Class II
• Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as

  Treace Medical Concepts, Inc. · Devices · 2024-06-02
  Class II
• Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO S

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only

  Abbott Medical · Devices · 2024-05-22
  Class II
• SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in pr

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Componen

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

  Stryker Orthopaedics · Devices · 2024-04-15
  Class II
• Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acu

  Advanced Medical Solutions Ltd. · Devices · 2024-10-01
  Class II
• Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata

  Olympus Corporation of the Americas · Devices · 2024-02-17
  Class II
• FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

  BioFire Diagnostics, LLC · Devices · 2024-08-07
  Class II
• Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• VITROS 3600 Immunodiagnostic System (New and Refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-22
  Class II
• Horizon Cardiology Hemo. Version 12.2.

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2024-08-21
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes a

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Baxter Operating Table TruSystem 7000, Product code REF 1841046

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number:

  Howmedica Osteonics Corp. · Devices · 2024-06-19
  Class II
• CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000873;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented to

  Limacorporate S.p.A · Devices · 2024-10-02
  Class II
• ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sect

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-09-04
  Class II
• Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 1

  Siemens Medical Solutions USA, Inc · Devices · 2024-03-21
  Class II
• Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe

  Olympus Corporation of the Americas · Devices · 2024-09-18
  Class II
• The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou

  Olympus Corporation of the Americas · Devices · 2024-07-01
  Class II
• Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emerge

  Sarnova HC, Llc · Devices · 2024-02-12
  Class II
• Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti

  CooperVision, Inc. · Devices · 2024-08-29
  Class II
• 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wi

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Achieva 1.5T Conversion, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD

  Philips North America Llc · Devices · 2024-02-15
  Class II
• iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh

  Baxter Healthcare Corporation · Devices · 2024-06-04
  Class II
• Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• 25-LHP-828, HeNe Laser System, 35 mW

  PACIFIC LASERTECH, LLC · Devices · 2024-03-01
  Class II
• VACUETTE SAFELINK, REF: 450210

  Greiner Bio-One GmbH · Devices · 2024-11-19
  Class II
• BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

  Smiths Medical ASD, Inc. · Devices · 2024-10-28
  Class II
• CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

  Philips North America · Devices · 2024-02-28
  Class II
• BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergeni

  Cardinal Health 200, LLC · Devices · 2024-04-17
  Class II
• BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runni

  Philips North America · Devices · 2024-02-28
  Class II
• GE Healthcare Innova IGS 5, computed tomography x-ray system

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000960;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming,

  Stryker Corporation · Devices · 2024-07-24
  Class II
• Shoulder, SESH18I; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra

  Philips North America Llc · Devices · 2024-09-03
  Class II
• Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fis

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Discovery MR750w 3.0T, whole body magnetic resonance scanner

  GE Medical Systems, LLC · Devices · 2024-10-28
  Class II
• TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

  Smiths Medical ASD, Inc. · Devices · 2024-10-28
  Class II
• Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated ana

  Randox Laboratories Ltd. · Devices · 2024-02-14
  Class II
• Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video

  SEER MEDICAL PTY LTD · Devices · 2024-08-12
  Class II
• Intera 1.5T R11, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,

  Stryker Corporation · Devices · 2024-07-24
  Class II
• X3 TRIATHLON CS INSERT NO 3 10 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Mod

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-02
  Class II
• IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restoratio

  IVOCLAR VIVADENT AG · Devices · 2024-04-05
  Class II
• Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an

  Philips North America Llc · Devices · 2024-09-03
  Class II
• VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000594;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• X-Guide Handpiece Adaptor Sleeve 3, Model P010727

  X-NAV Technologies, LLC · Devices · 2024-03-04
  Class II
• Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti

  Stryker Corporation · Devices · 2024-07-24
  Class II
• ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• SENSE Breast Coil

  Philips North America Llc · Devices · 2024-11-04
  Class II
• Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contou

  Meddev Corp · Devices · 2024-07-12
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000628;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-r

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Custodiol HTK Solution, 500ml bottle. 10 per carton.

  Dr Franz Koehler Chemie Gmbh · Devices · 2024-01-09
  Class II
• smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELL

  Smith & Nephew Inc · Devices · 2024-10-02
  Class II
• Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch compon

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a

  Securitas Healthcare LLC · Devices · 2024-04-11
  Class II
• VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b)

  Baxter Healthcare Corporation · Devices · 2024-06-04
  Class II
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

  Siemens Healthcare Diagnostics Inc · Devices · 2024-09-24
  Class II
• MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific

  Macherey Nagel Gmbh & Co. Kg · Devices · 2024-04-04
  Class II
• Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

  Medtronic Inc. · Devices · 2024-02-16
  Class II
• SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

  Ethicon Sarl, a Johnson & Johnson Company · Devices · 2024-06-11
  Class II
• medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000023;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Achieva 1.5T Initial, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril

  Physio-Control, Inc. · Devices · 2024-08-09
  Class II
• 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

  3M Company - Health Care Business · Devices · 2024-08-14
  Class II
• smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Unco

  Smith & Nephew Inc · Devices · 2024-10-02
  Class II
• 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

  Beckman Coulter Inc. · Devices · 2024-05-27
  Class II
• BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• VITROS XT 7600 Integrated System, Catalog No. 6844461

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001054;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71

  Smith & Nephew Inc · Devices · 2024-04-24
  Class II
• RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLI

  Boston Scientific Corporation · Devices · 2024-06-27
  Class II
• Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

  Covidien, LP · Devices · 2024-02-28
  Class II
• Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorde

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60

  Omnia Medical · Devices · 2024-07-15
  Class II
• Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)

  Baxter Healthcare Corporation · Devices · 2024-02-28
  Class II
• MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicat

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

  IsoTis OrthoBiologics, Inc. · Devices · 2024-11-27
  Class II
• MICRO-X Rover Mobile X-ray System, # MXU-RV35

  Micro-X Ltd. · Devices · 2024-10-22
  Class II
• Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) ad

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• 8MM,FORCE BIPOLAR,IS4000 REF 471405

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-04-17
  Class II
• Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Co

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001306;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63

  Becton Dickinson Infusion Therapy Systems, Inc. · Devices · 2024-06-26
  Class II
• Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr

  Philips North America Llc · Devices · 2024-09-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001711;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-08-06
  Class II
• Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decor

  Stryker Corporation · Devices · 2024-07-24
  Class II
• Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged

  Windstone Medical Packaging, Inc. · Devices · 2024-08-16
  Class II
• Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode

  Olympus Corporation of the Americas · Devices · 2024-02-17
  Class II
• Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu

  Bard Peripheral Vascular Inc · Devices · 2024-07-10
  Class II
• American Contract Systems Hand Pack convenience kit

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicat

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

  Tornier, Inc · Devices · 2024-08-29
  Class II
• smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur

  Smith & Nephew Inc · Devices · 2024-10-02
  Class II
• 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584404;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-03
  Class II
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-01-02
  Class II
• System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allur

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-08-22
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001484;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbod

  Stryker Spine · Devices · 2024-08-23
  Class II
• Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va

  Cook Incorporated · Devices · 2024-03-01
  Class II
• Intera 1.0T Power/Pulsar, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI

  BioFire Diagnostics, LLC · Devices · 2024-05-16
  Class II
• EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pe

  Boston Scientific Corporation · Devices · 2024-02-20
  Class II
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;

  Beckman Coulter, Inc. · Devices · 2024-07-10
  Class II
• Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 149

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-09-04
  Class II
• Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Achieva 1.5T Initial system. Model (REF) Numbers 781178.

  Philips North America · Devices · 2024-01-03
  Class II
• MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use i

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

  Howmedica Osteonics Corp. · Devices · 2024-05-23
  Class II
• DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conn

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-22
  Class II
• ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001019;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicate

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-08-21
  Class II
• See RES description

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10

  Bard Peripheral Vascular Inc · Devices · 2024-09-30
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M

  Sklar Instruments · Devices · 2024-12-03
  Class II
• American Contract Systems Biopsy Drape Pack convenience kit

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o

  CORNEAT VISION, LTD. · Devices · 2024-10-16
  Class II
• DAC 044 115cm, Catalog: 90760

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S

  Merit Medical Systems, Inc. · Devices · 2024-05-22
  Class II
• Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3

  Merit Medical Systems, Inc. · Devices · 2024-08-30
  Class II
• The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio

  Beckman Coulter, Inc. · Devices · 2024-08-28
  Class II
• Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001174;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Sys

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D

  Cardinal Health 200, LLC · Devices · 2024-03-27
  Class II
• GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device M

  Philips North America Llc · Devices · 2024-05-03
  Class II
• MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

  Moximed, Inc. · Devices · 2024-12-02
  Class II
• RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mod

  TMJ Solutions Inc · Devices · 2024-07-24
  Class II
• Bodor P and C series laser cutting machines

  Jinan Bodor Cnc Machine Co Ltd · Devices · 2024-12-19
  Class II
• Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

  Microbiologics Inc · Devices · 2024-01-08
  Class II
• Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

  Remote Diagnostic Technologies Ltd. · Devices · 2024-05-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

  ROi CPS LLC · Devices · 2024-07-24
  Class II
• Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biote

  Wondfo USA Co Ltd · Devices · 2024-04-22
  Class II
• SIGNA Architect, Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-10-28
  Class II
• medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

  Cypress Medical Products LLC · Devices · 2024-08-20
  Class II
• Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe

  Baxter Healthcare Corporation · Devices · 2024-07-17
  Class II
• Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th

  Philips North America Llc · Devices · 2024-09-03
  Class II
• SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a

  Philips North America Llc · Devices · 2024-09-03
  Class II
• ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedi

  Boston Scientific Corporation · Devices · 2024-02-20
  Class II
• MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001554;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 -

  United Orthopedic Corporation · Devices · 2024-01-03
  Class II
• Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasoun

  Echonous Inc · Devices · 2024-05-09
  Class II
• ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002074;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Regard Kit containing the Microtek decanter

  ROi CPS LLC · Devices · 2024-06-17
  Class II
• CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to conta

  The Metrix Company · Devices · 2024-10-09
  Class II
• KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for cultur

  Microbiologics Inc · Devices · 2024-03-06
  Class II
• DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

  Diasorin Inc. · Devices · 2024-11-07
  Class II
• Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 6

  Terumo Cardiovascular Systems Corporation · Devices · 2024-02-20
  Class II
• Ziehm Vision R. Iterventional fluoroscopic x-ray system

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalm

  Carwild Corporation · Devices · 2024-10-22
  Class II
• Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300

  Baxter Healthcare Corporation · Devices · 2024-06-28
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001608;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3

  GE Medical Systems, LLC · Devices · 2024-11-25
  Class II
• 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

  Luminex Corporation · Devices · 2024-06-20
  Class II
• SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, se

  Beckman Coulter, Inc. · Devices · 2024-07-12
  Class II
• Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-10-21
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-02-06
  Class II
• Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-03
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC810

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

  Medtronic Neuromodulation · Devices · 2024-09-24
  Class II
• Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administ

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001380;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides

  Integra LifeSciences Corp. · Devices · 2024-12-16
  Class II
• WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Pr

  CooperSurgical, Inc. · Devices · 2024-11-15
  Class II
• Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the

  DKK Dai-Ichi Shomei Co., Ltd. · Devices · 2024-07-09
  Class II
• FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

  B Braun Medical Inc · Devices · 2024-05-17
  Class II
• ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-26
  Class II
• Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• Cysto, FTCY03L; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

  ASPEN SURGICAL · Devices · 2024-06-03
  Class II
• 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATAR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT72

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-242

  Sklar Instruments · Devices · 2024-12-03
  Class II
• TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use wi

  Integra LifeSciences Corp. · Devices · 2024-07-09
  Class II
• Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

  Young Dental Manufacturing I, LLC · Devices · 2024-05-13
  Class II
• 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Num

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into th

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

  Wright Medical Technology, Inc. · Devices · 2024-03-06
  Class II
• Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

  Olympus Corporation of the Americas · Devices · 2024-08-23
  Class II
• Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

  Zoe Medical Incorporated · Devices · 2024-08-13
  Class II
• Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue

  Olympus Corporation of the Americas · Devices · 2024-03-01
  Class II
• Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal

  Randox Laboratories, Limited · Devices · 2024-12-20
  Class II
• Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a to

  Olympus Corporation of the Americas · Devices · 2024-04-24
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 50

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.

  Emergency Products & Research · Devices · 2024-02-27
  Class II
• Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227

  Beaver Visitec International, Inc. · Devices · 2024-05-10
  Class II
• Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x an

  Hermes Medical Solutions AB · Devices · 2024-10-31
  Class II
• FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

  ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL · Devices · 2024-07-04
  Class II
• Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM RE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• Baxter Solution Set with Duo-Vent Spike, REF 2R8404

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class II
• Colonoscope, Model Number CF-HQ190I.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-30
  Class II
• TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584625;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests

  Quidel Corporation · Devices · 2024-03-05
  Class II
• Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming

  Augustine Temperature Management, LLC · Devices · 2024-02-15
  Class II
• Vantage Titan, Model: MRT-1504

  Canon Medical System, USA, INC. · Devices · 2024-01-29
  Class II
• Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto

  Merit Medical Systems, Inc. · Devices · 2024-08-30
  Class II
• Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM

  Exactech, Inc. · Devices · 2024-12-31
  Class II
• IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

  IVOCLAR VIVADENT AG · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-08-15
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactiv

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

  Philips North America Llc · Devices · 2024-05-03
  Class II
• AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode

  Ad-Tech Medical Instrument Corporation · Devices · 2024-09-19
  Class II
• Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Evolution Upgrade 3.0T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

  AURIS HEALTH INC · Devices · 2024-08-02
  Class II
• Change Healthcare Cardiology Hemodynamics software

  A L I Technologies Ltd · Devices · 2024-12-02
  Class II
• Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Synapse PACS - Version 7.3.000

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-10
  Class II
• Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

  Philips North America Llc · Devices · 2024-05-03
  Class II
• COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pi

  Boston Scientific Corporation · Devices · 2024-07-18
  Class II
• 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 I

  3M Company - Health Care Business · Devices · 2024-02-20
  Class II
• AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000813;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

  Baxter Healthcare Corporation · Devices · 2024-11-19
  Class II
• MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• PE Centrifuge, REF: B36365, a component of the Power Express

  Beckman Coulter Biomedical GmbH · Devices · 2024-07-17
  Class II
• Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses

  Augustine Temperature Management, LLC · Devices · 2024-12-04
  Class II
• Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Devices · 2024-01-15
  Class II
• medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

  Navinetics Inc · Devices · 2024-02-26
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) adm

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography,

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), RE

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2024-08-12
  Class II
• Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION L

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRES

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vect

  MED-EL Elektromedizinische Gereate, Gmbh · Devices · 2024-04-18
  Class II
• Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

  Cypress Medical Products LLC · Devices · 2024-08-20
  Class II
• GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001809;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584727;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in p

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialys

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-21
  Class II
• ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stab

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

  New Medical Technologies Gmbh · Devices · 2024-12-19
  Class II
• Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

  Parker Laboratories, Inc. · Devices · 2024-03-22
  Class II
• Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70

  Channel Medsystems, Inc. · Devices · 2024-05-03
  Class II
• Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

  Stryker Orthopaedics · Devices · 2024-04-15
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive dis

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable ta

  Pivotal Health Solutions, Inc. · Devices · 2024-04-29
  Class II
• Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Numbe

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-01-09
  Class II
• EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicat

  Philips North America Llc · Devices · 2024-06-28
  Class II
• KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

  Instrumentation Laboratory · Devices · 2024-12-18
  Class II
• MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-30
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• RUMMELL, Medline Item No. ST006ST

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicate

  Philips North America Llc · Devices · 2024-06-28
  Class II
• Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An elect

  CooperSurgical, Inc. · Devices · 2024-11-15
  Class II
• System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 A

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-08-22
  Class II
• System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDia

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-08-22
  Class II
• Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CD

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

  Baxter Healthcare Corporation · Devices · 2024-12-20
  Class II
• WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administra

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Serie

  Defibtech, LLC · Devices · 2024-10-14
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS98

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Ster

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-03
  Class II
• Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-12-05
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.

  Parker Laboratories, Inc. · Devices · 2024-01-22
  Class II
• VITROS Performance Verifier II

  Ortho-Clinical Diagnostics · Devices · 2024-02-27
  Class II
• Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Nu

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant K

  Thoratec LLC · Devices · 2024-06-25
  Class II
• Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-247

  Sklar Instruments · Devices · 2024-12-03
  Class II
• medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2024-11-01
  Class II
• Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

  Smith & Nephew, Inc. · Devices · 2024-07-09
  Class II
• EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

  Medtronic Perfusion Systems · Devices · 2024-12-12
  Class II
• Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip,

  Roche Diabetes Care, Inc. · Devices · 2024-05-13
  Class II
• Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-

  Exactech, Inc. · Devices · 2024-04-26
  Class II
• Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL

  Covidien, LP · Devices · 2024-02-28
  Class II
• Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indi

  Defibtech, LLC · Devices · 2024-10-14
  Class II
• Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.

  Philips North America · Devices · 2024-01-03
  Class II
• Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

  Beckman Coulter, Inc. · Devices · 2024-06-04
  Class II
• Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

  Btt Health Gmbh · Devices · 2024-08-01
  Class II
• Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

  CooperSurgical, Inc. · Devices · 2024-02-16
  Class II
• Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

  Mazor Robotics Ltd · Devices · 2024-07-17
  Class II
• DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodial

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

  Medtronic Neuromodulation · Devices · 2024-03-28
  Class II
• Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BAS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) a

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

  Baxter Healthcare Corporation · Devices · 2024-10-11
  Class II
• AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra

  Philips North America Llc · Devices · 2024-09-03
  Class II
• Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes w

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-04
  Class II
• ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• BD Pyxis MedStation ES, REF: 323, Medication Cabinet

  CareFusion 303, Inc. · Devices · 2024-04-15
  Class II
• ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• 8MM,FORCE BIPOLAR,IS4000 REF 470405

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

  Schiller, Ag · Devices · 2024-07-24
  Class II
• Halyard ENT - Medical convenience kits Model Number: VMED011-01

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

  Caire, Inc. · Devices · 2024-10-04
  Class II
• Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthro

  Tornier S.A.S. · Devices · 2024-12-18
  Class II
• Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000120;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• SENSE Breast Coil 3.0T 7ch

  Philips North America Llc · Devices · 2024-11-04
  Class II
• Pink Luminous Breast, Breast transilluminator

  Silkprousa LLC · Devices · 2024-05-20
  Class II
• Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporati

  Philips North America Llc · Devices · 2024-03-22
  Class II
• 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-08-21
  Class II
• The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-07-10
  Class II
• Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

  Stryker Orthopaedics · Devices · 2024-04-15
  Class II
• Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

  CareFusion 303, Inc. · Devices · 2024-08-15
  Class II
• Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

  Inspire Medical Systems Inc. · Devices · 2024-07-31
  Class II
• NxTAG Respiratory Pathogen Panel, REF: I051C0447

  Luminex Molecular Diagnostics Inc · Devices · 2024-09-05
  Class II
• InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid en

  Olympus Corporation of the Americas · Devices · 2024-04-03
  Class II
• Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonan

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-26
  Class II
• Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-08-08
  Class II
• 8MM, POTTS SCISSORS, IS4000 REF 470001

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) a

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an inte

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.

  Philips North America · Devices · 2024-01-03
  Class II
• Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 d

  Alphatec Spine, Inc. · Devices · 2024-12-15
  Class II
• The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.

  Magellan Diagnostics, Inc. · Devices · 2024-02-23
  Class II
• L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539

  Argon Medical Devices, Inc · Devices · 2024-06-14
  Class II
• BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306

  CareFusion 303, Inc. · Devices · 2024-04-15
  Class II
• LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076

  Physio-Control, Inc. · Devices · 2024-08-30
  Class II
• 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-18
  Class II
• Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.

  Philips North America · Devices · 2024-01-03
  Class II
• SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Mag

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)

  Stryker Neurovascular · Devices · 2024-08-30
  Class II
• ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS98

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decor

  Stryker Corporation · Devices · 2024-07-24
  Class II
• Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it

  Smith & Nephew Medical, Ltd. · Devices · 2024-03-11
  Class II
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-01-09
  Class II
• Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTB

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

  Brasseler USA I Lp · Devices · 2024-01-11
  Class II
• TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Colonoscope, Model Number PCF-HQ190L.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number

  3M Company - Health Care Business · Devices · 2024-01-12
  Class II
• Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf

  Micro Therapeutics, Inc. · Devices · 2024-01-11
  Class II
• NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500

  O&M HALYARD, INC. · Devices · 2024-11-08
  Class II
• Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

  Intuitive Surgical, Inc. · Devices · 2024-03-13
  Class II
• SmartPath to dStream for 1.5T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

  Aesculap Inc · Devices · 2024-01-09
  Class II
• NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented

  Novosource, LLC · Devices · 2024-09-19
  Class II
• SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner

  Artivion, Inc · Devices · 2024-05-28
  Class II
• CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to conta

  The Metrix Company · Devices · 2024-10-09
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an inter

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166

  Becton, Dickinson and Company, BD Biosciences · Devices · 2024-05-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes w

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-05-16
  Class II
• BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal car

  Maquet Medical Systems USA · Devices · 2024-01-08
  Class II
• 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 Th

  Westmed, Inc. · Devices · 2024-09-27
  Class II
• GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5)

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product De

  MICROspecialties, Inc. · Devices · 2024-06-05
  Class II
• SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic inten

  The Metrix Company · Devices · 2024-10-09
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

  Integra LifeSciences Corp. · Devices · 2024-09-26
  Class II
• Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

  MICROspecialties, Inc. · Devices · 2024-06-05
  Class II
• EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

  Olympus Corporation of the Americas · Devices · 2024-10-31
  Class II
• 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612

  Coloplast Manufacturing US, LLC · Devices · 2024-12-02
  Class II
• Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal

  B. Braun Medical, Inc. · Devices · 2024-12-04
  Class II
• RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x

  Karl Storz Endoscopy · Devices · 2024-10-11
  Class II
• VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-10-11
  Class II
• Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• URINE KIT, SKU DYKM1845; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2024-11-01
  Class II
• Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system

  Boston Scientific Corporation · Devices · 2024-02-20
  Class II
• Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile

  Abbott Medical · Devices · 2024-10-17
  Class II
• Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear th

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline E

  Defibtech, LLC · Devices · 2024-10-14
  Class II
• Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

  Olympus Corporation of the Americas · Devices · 2024-09-13
  Class II
• Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Shar

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection

  C.R. Bard Inc · Devices · 2024-05-09
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps

  Zyno Medical LLC · Devices · 2024-06-04
  Class II
• SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic inten

  The Metrix Company · Devices · 2024-10-09
  Class II
• Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 18102

  Sol-Millennium Medical Inc. · Devices · 2024-05-09
  Class II
• Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEED

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 -

  United Orthopedic Corporation · Devices · 2024-01-03
  Class II
• Synapse PACS - Version 7.2.200

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-01-10
  Class II
• medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.

  Puritan Medical Products Company, Llc · Devices · 2024-02-21
  Class II
• medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-17
  Class II
• Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated

  Steris Corporation · Devices · 2024-06-13
  Class II
• Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

  XTANT Medical Holdings, Inc · Devices · 2024-08-21
  Class II
• Galaxy System (GAL-001)

  Noah Medical · Devices · 2024-10-25
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contou

  Meddev Corp · Devices · 2024-07-12
  Class II
• Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V

  Kreatech Biotechnology Bv · Devices · 2024-11-01
  Class II
• smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL

  Smith & Nephew Inc · Devices · 2024-10-02
  Class II
• GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric

  Boston Scientific Corporation · Devices · 2024-02-20
  Class II
• OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoros

  GE OEC Medical Systems, Inc · Devices · 2024-11-21
  Class II
• Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product D

  B Braun Medical Inc · Devices · 2024-06-14
  Class II
• Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISIO

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, R

  Sol-Millennium Medical Inc. · Devices · 2024-05-09
  Class II
• ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabiliz

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.

  Philips North America · Devices · 2024-01-03
  Class II
• COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

  IVOCLAR VIVADENT AG · Devices · 2024-04-05
  Class II
• RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

  Biomet, Inc. · Devices · 2024-05-17
  Class II
• EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric an

  Boston Scientific Corporation · Devices · 2024-02-20
  Class II
• Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03;

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Cathete

  Cardinal Health 200, LLC · Devices · 2024-05-29
  Class II
• VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to conta

  The Metrix Company · Devices · 2024-10-09
  Class II
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.

  Spacelabs Healthcare, Inc. · Devices · 2024-11-25
  Class II
• Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only

  Abbott Medical · Devices · 2024-05-22
  Class II
• Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• See DocMan

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Day Surgery General Pack, FHGE18T; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001836;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• Spectrum IQ Infusion pump, Product Code 357009

  Baxter Healthcare Corporation · Devices · 2024-04-09
  Class II
• 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Num

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabi

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contain

  Stryker Corporation · Devices · 2024-06-03
  Class II
• Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff

  Mirion Technologies (Capintec), Inc. · Devices · 2024-04-22
  Class II
• Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610

  GE Medical Systems, LLC · Devices · 2024-11-18
  Class II
• CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A;

  Sklar Instruments · Devices · 2024-12-03
  Class II
• X3 TRIATHLON CS INSERT NO 7 9 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

  Applied Medical Technology Inc · Devices · 2024-05-14
  Class II
• BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3

  Argon Medical Devices, Inc · Devices · 2024-07-02
  Class II
• Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Str

  Wondfo USA Co Ltd · Devices · 2024-04-22
  Class II
• Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the

  Stryker Corporation · Devices · 2024-06-03
  Class II
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi

  MICROVENTION INC. · Devices · 2024-08-05
  Class II
• Achieva 3.0T for PET, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN,

  Hologic Inc · Devices · 2024-06-13
  Class II
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Service

  UNIMAX MEDICAL SYSTEMS INC · Devices · 2024-06-25
  Class II
• AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,

  Hollister Incorporated · Devices · 2024-12-23
  Class II
• AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire int

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitativ

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Produ

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-05-21
  Class II
• Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: Th

  Hitachi America, Ltd., Particle Therapy Division · Devices · 2024-05-27
  Class II
• CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

  Caire, Inc. · Devices · 2024-10-04
  Class II
• Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conne

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• MediBeads Neck Wrap, Item Number 34320

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

  Ad-Tech Medical Instrument Corporation · Devices · 2024-09-19
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00

  Zimmer, Inc. · Devices · 2024-07-02
  Class II
• Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic d

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX

  W L Gore & Associates, Inc. · Devices · 2024-07-01
  Class II
• Ureteral dilator, REF RBD014

  Coloplast Manufacturing US, LLC · Devices · 2024-03-11
  Class II
• Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K

  Boston Scientific Neuromodulation Corporation · Devices · 2024-04-18
  Class II
• WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.

  WOM World Of Medicine AG · Devices · 2024-05-24
  Class II
• DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

  Beckman Coulter, Inc. · Devices · 2024-05-22
  Class II
• Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

  Medtronic Xomed, Inc. · Devices · 2024-07-05
  Class II
• Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

  Baxter Healthcare Corporation · Devices · 2024-10-11
  Class II
• NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-

  NxStage Medical Inc · Devices · 2024-05-14
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ziehm Vision FD. Interventional fluoroscopic x-ray system

  Orthoscan, Inc. · Devices · 2024-08-08
  Class II
• Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Descriptio

  Nova Ortho-Med Inc · Devices · 2024-08-26
  Class II
• Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, I

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• 3M Durapore Surgical Tape, Catalog Number 1538-118

  3M Company - Health Care Business · Devices · 2024-03-20
  Class II
• ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and st

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• MR 5300, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Microscissor Tip (Disposable); Microline Catalog #: 3122.

  Microline Surgical, Inc. · Devices · 2024-11-05
  Class II
• Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

  Caire, Inc. · Devices · 2024-10-04
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918

  Sklar Instruments · Devices · 2024-12-03
  Class II
• Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-02
  Class II
• Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-10-21
  Class II
• BlueFIRE Inflation Device, REF: IN10140

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• Thermalon Eye Compress, Item Number 2434

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-18
  Class II
• Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2024-08-21
  Class II
• DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

  Smith & Nephew, Inc. · Devices · 2024-07-09
  Class II
• AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number

  B. Braun Medical, Inc. · Devices · 2024-08-08
  Class II
• dS Breast 7ch 1.5T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS68

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-05
  Class II
• TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILIC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Endovascular AAA Pack, ESED52B; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-

  HeartSine Technologies Ltd · Devices · 2024-02-14
  Class II
• Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

  YAMAHA MOTOR CORPORATION · Devices · 2024-04-17
  Class II
• ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-01-24
  Class II
• Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL

  Neilmed Pharmaceuticals Inc · Devices · 2024-12-28
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Philips Zenition 50, Model Number: 718096

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-10-07
  Class II
• MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or li

  Ethicon, Inc. · Devices · 2024-05-10
  Class II
• MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000709;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It

  Beckman Coulter, Inc. · Devices · 2024-02-29
  Class II
• Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 58001

  Beaver Visitec International, Inc. · Devices · 2024-05-10
  Class II
• Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue

  Olympus Corporation of the Americas · Devices · 2024-03-01
  Class II
• HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

  Horiba Instruments Incorporated · Devices · 2024-03-28
  Class II
• TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS

  Baxter Healthcare Corporation · Devices · 2024-03-26
  Class II
• medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of

  Covidien, LP · Devices · 2024-01-25
  Class II
• Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide thro

  Medical Depot Inc. · Devices · 2024-06-14
  Class II
• MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in

  Philips North America Llc · Devices · 2024-09-03
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, p

  GE Healthcare Finland Oy · Devices · 2024-04-05
  Class II
• Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• X3 TRIATHLON CS INSERT NO 6 11 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

  Ethicon, Inc. · Devices · 2024-04-23
  Class II
• Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determina

  Roche Diagnostics Operations, Inc. · Devices · 2024-08-15
  Class II
• Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Versi

  Trinity Sterile, Inc. · Devices · 2024-12-13
  Class II
• Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a dia

  Philips North America Llc · Devices · 2024-05-03
  Class II
• ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-413

  Sklar Instruments · Devices · 2024-12-03
  Class II
• AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W

  MICROspecialties, Inc. · Devices · 2024-06-05
  Class II
• Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 26456

  Dental EZ Group Star Dental Division · Devices · 2024-05-30
  Class II
• Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injec

  Merit Medical Systems, Inc. · Devices · 2024-08-30
  Class II
• basixTOUCH Inflation Device, REF: IN8140/A

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO

  GE Medical Systems, LLC · Devices · 2024-11-18
  Class II
• Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system

  CareFusion 303, Inc. · Devices · 2024-07-09
  Class II
• Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Thermalon Heating Pad, Item Number 24002

  Bruder Healthcare Company, LLC · Devices · 2024-02-21
  Class II
• Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.

  Philips North America · Devices · 2024-01-03
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergenc

  Sarnova HC, Llc · Devices · 2024-02-12
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

  Covidien, LP · Devices · 2024-02-28
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by tra

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene

  Becton Dickinson & Co. · Devices · 2024-02-29
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001721;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

  Securitas Healthcare LLC · Devices · 2024-06-20
  Class II
• MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of CO

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.

  Aesculap Inc · Devices · 2024-01-09
  Class II
• Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determi

  Beckman Coulter Inc. · Devices · 2024-11-08
  Class II
• Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP

  Smiths Medical ASD Inc. · Devices · 2024-06-26
  Class II
• IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restoratio

  IVOCLAR VIVADENT AG · Devices · 2024-04-05
  Class II
• Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revisi

  Medtronic Neuromodulation · Devices · 2024-05-10
  Class II
• FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2024-11-01
  Class II
• Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Descri

  Alcon Research LLC · Devices · 2024-04-22
  Class II
• Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate th

  DKK Dai-Ichi Shomei Co., Ltd. · Devices · 2024-07-09
  Class II
• EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti

  Philips North America Llc · Devices · 2024-05-03
  Class II
• 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-05-16
  Class II
• ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-18
  Class II
• Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile s

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• StabiliT TOUCH Syringe, REF: IN8VCF/B

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18

  Cook Incorporated · Devices · 2024-10-08
  Class II
• ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation

  Olympus Corporation of the Americas · Devices · 2024-06-21
  Class II
• CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.n

  St. Jude Medical · Devices · 2024-10-05
  Class II
• Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona

  Siemens AG/Siemens Healthcare GmbH · Devices · 2024-06-26
  Class II
• Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001658;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500

  Philips North America · Devices · 2024-08-30
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an int

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu

  BALT USA, LLC · Devices · 2024-01-03
  Class II
• SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• IntelliSystem Inflation Device, REF: IN1525/D

  Merit Medical Systems, Inc. · Devices · 2024-08-19
  Class II
• 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-00

  Stryker Corporation · Devices · 2024-12-03
  Class II
• GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Colonoscope, Model Number PCF-H190TL.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGEN

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

  Omnia Medical · Devices · 2024-07-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001374;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that

  Randox Laboratories Ltd. · Devices · 2024-03-01
  Class II
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

  Biomet, Inc. · Devices · 2024-10-21
  Class II
• RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.

  RAYSEARCH LABORATORIES AB · Devices · 2024-03-28
  Class II
• Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Pr

  Philips Ultrasound, Inc. · Devices · 2024-03-23
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the us

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• American Contract Systems Special Procedure Pack convenience kit

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• Ingenia Ambition X, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747

  Outset Medical, Inc. · Devices · 2024-04-30
  Class II
• SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963

  Ethicon Sarl, a Johnson & Johnson Company · Devices · 2024-06-11
  Class II
• 8MM,COBRA GRASPER,IS4000 REF 471190

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devic

  Philips North America Llc · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001695;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S

  Think Surgical, Inc. · Devices · 2024-02-12
  Class II
• Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

  Hobbs Medical, Inc. · Devices · 2024-10-04
  Class II
• GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

  GE Medical Systems, SCS · Devices · 2024-03-18
  Class II
• General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Numbe

  Cypress Medical Products LLC · Devices · 2024-08-06
  Class II
• Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-

  Olympus Corporation of the Americas · Devices · 2024-11-25
  Class II
• DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• Baxter Spectrum IQ Infusion Pump, Product Code 3570009

  Baxter Healthcare Corporation · Devices · 2024-03-20
  Class II
• Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-02-06
  Class II
• ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-12
  Class II
• Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

  Baxter Healthcare Corporation · Devices · 2024-10-11
  Class II
• Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor

  Verathon, Inc. · Devices · 2024-04-29
  Class II
• ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001331;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a

  Philips North America Llc · Devices · 2024-05-03
  Class II
• ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emerge

  Siemens Medical Solutions USA, Inc · Devices · 2024-05-31
  Class II
• Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retr

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Nu

  Cardinal Health 200, LLC · Devices · 2024-05-29
  Class II
• Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER

  GE Medical Systems, LLC · Devices · 2024-10-28
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000501;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitati

  Beckman Coulter, Inc. · Devices · 2024-04-18
  Class II
• Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid s

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain

  The Metrix Company · Devices · 2024-10-09
  Class II
• TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

  Howmedica Osteonics Corp. · Devices · 2024-02-27
  Class II
• Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728

  Philips North America Llc · Devices · 2024-04-15
  Class II
• Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surg

  Covidien, LP · Devices · 2024-04-15
  Class II
• Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use i

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000985;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Pr

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000195;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syrin

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Centurion PICC LINE SECUREMENT KIT, Product Code IVS565

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV)

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001545;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf

  Micro Therapeutics, Inc. · Devices · 2024-01-11
  Class II
• Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syr

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

  Merit Medical Systems, Inc. · Devices · 2024-08-12
  Class II
• Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

  Shimadzu Corp. Analytical & Measuring Instruments Div. · Devices · 2024-10-09
  Class II
• ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Us

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-25
  Class II
• PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypo

  Augustine Temperature Management, LLC · Devices · 2024-12-16
  Class II
• Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated a

  Randox Laboratories Ltd. · Devices · 2024-06-07
  Class II
• FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• Fusion Pro 24, Model 17000

  Epilog Laser Corp. · Devices · 2024-08-08
  Class II
• Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Devices · 2024-09-06
  Class II
• Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV

  GE Medical Systems, LLC · Devices · 2024-11-18
  Class II
• Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-02-06
  Class II
• STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

  Baxter Healthcare Corporation · Devices · 2024-02-14
  Class II
• SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in pr

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

  Baxter Healthcare Corporation · Devices · 2024-10-23
  Class II
• Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEUR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-06
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur

  Olympus Corporation of the Americas · Devices · 2024-03-07
  Class II
• Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

  Cook Incorporated · Devices · 2024-10-14
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fis

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE

  Baxter Healthcare Corporation · Devices · 2024-03-26
  Class II
• SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK w

  Medtronic Neuromodulation · Devices · 2024-11-21
  Class II
• Intera 1.5T Power/Pulsar, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (

  QUIDELORTHO · Devices · 2024-04-09
  Class II
• Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

  INCIPIO DEVICES · Devices · 2024-10-30
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Bio

  Bard Peripheral Vascular Inc · Devices · 2024-08-02
  Class II
• Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate th

  DKK Dai-Ichi Shomei Co., Ltd. · Devices · 2024-07-09
  Class II
• 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• American Contract Systems Cataract Pack convenience kit

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodont

  Straight Smile, LLC · Devices · 2024-11-04
  Class II
• Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, d

  Stryker Corporation · Devices · 2024-07-24
  Class II
• SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Embrace Drill Tower, Standard/Lateral (25mm)

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-01-29
  Class II
• Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

  Ossur H / F · Devices · 2024-08-20
  Class II
• Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory sof

  Becton Dickinson & Co. · Devices · 2024-09-12
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR3

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.ne

  St. Jude Medical · Devices · 2024-10-05
  Class II
• American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American C

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitat

  Becton Dickinson & Co. · Devices · 2024-11-06
  Class II
• Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with c

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-14
  Class II
• Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000288;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen

  DePuy Orthopaedics, Inc. · Devices · 2024-03-12
  Class II
• BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060

  MICROspecialties, Inc. · Devices · 2024-06-05
  Class II
• Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

  Onkos Surgical, Inc. · Devices · 2024-09-22
  Class II
• ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descr

  Integrity Implants Inc. · Devices · 2024-12-20
  Class II
• MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxi

  ETHICON, INC. · Devices · 2024-10-08
  Class II
• Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline Sw

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-05
  Class II
• medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 S

  West Pharmaceutical Services AZ, Inc. · Devices · 2024-09-24
  Class II
• Centurion STERILE TRACH BRUSH, Product Code 6225ST

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interacti

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• ENT, COEN27N; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) admin

  B. Braun Medical, Inc. · Devices · 2024-06-17
  Class II
• Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Trumpet, Needle Guide, Cat# TMS-200

  Technicality Inc. · Devices · 2024-01-31
  Class II
• FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

  BioFire Diagnostics, LLC · Devices · 2024-08-07
  Class II
• CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 i

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-01-23
  Class II
• 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2024-08-21
  Class II
• GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Disc

  GE Healthcare (China) Co., Ltd. · Devices · 2024-11-05
  Class II
• ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during

  B Braun Medical Inc · Devices · 2024-08-15
  Class II
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

  Beckman Coulter, Inc. · Devices · 2024-05-22
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

  Applied Medical Technology Inc · Devices · 2024-11-26
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

  Medtronic Perfusion Systems · Devices · 2024-10-03
  Class II
• CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides

  Integra LifeSciences Corp. · Devices · 2024-12-16
  Class II
• Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Pump 371 14F LT CMR Set; Product Code: 0048-0045;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000287;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

  Cook Medical Incorporated · Devices · 2024-04-01
  Class II
• Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drai

  Boston Scientific Corporation · Devices · 2024-07-18
  Class II
• The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou

  Olympus Corporation of the Americas · Devices · 2024-07-01
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000404;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Pr

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-281

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2024-05-22
  Class II
• Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238

  Stryker Neurovascular · Devices · 2024-04-23
  Class II
• Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Pr

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• 20" Lead Wires, Replacement Part Number: 1067724-2

  EBI, LLC · Devices · 2024-03-22
  Class II
• Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A P

  Ultradent Products, Inc. · Devices · 2024-08-02
  Class II
• VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibra

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-03-01
  Class II
• Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Pr

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2024-11-01
  Class II
• Temporary Titanium Abutments

  DDS Lab · Devices · 2024-12-06
  Class II
• Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a co

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-09-17
  Class II
• RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that comb

  Reflexion Medical, Inc. · Devices · 2024-04-16
  Class II
• Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Pa

  Alcon Research, LLC · Devices · 2024-03-15
  Class II
• Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony

  Stryker Leibinger GmbH & Co. KG · Devices · 2024-03-29
  Class II
• ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Len

  Maquet Cardiovascular, LLC · Devices · 2024-05-17
  Class II
• Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and

  Olympus Corporation of the Americas · Devices · 2024-08-13
  Class II
• See DocMan

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including som

  RAYSEARCH LABORATORIES AB · Devices · 2024-02-23
  Class II
• Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products

  Microtek Medical Inc. · Devices · 2024-06-03
  Class II
• 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or no

  Zimmer GmbH · Devices · 2024-08-08
  Class II
• Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

  Ventana Medical Systems, Inc. · Devices · 2024-06-27
  Class II
• smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/15

  Smiths Medical ASD Inc. · Devices · 2024-07-18
  Class II
• 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh

  ConvaTec, Inc · Devices · 2024-11-29
  Class II
• RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-06-03
  Class II
• Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Ste

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Intera 0.5T Standard, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut

  CareFusion 303, Inc. · Devices · 2024-02-23
  Class II
• 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number

  3M Company - Health Care Business · Devices · 2024-01-12
  Class II
• Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSME

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in

  Philips North America Llc · Devices · 2024-09-03
  Class II
• BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125S

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming

  Augustine Temperature Management, LLC · Devices · 2024-02-15
  Class II
• Dialyzer Optiflux 160NRe

  Fresenius Medical Care Holdings, Inc. · Devices · 2024-12-05
  Class II
• Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/

  Medical Action Industries, Inc. 306 · Devices · 2024-06-11
  Class II
• X-Guide Handpiece Adaptor Sleeve 1, Model P010701

  X-NAV Technologies, LLC · Devices · 2024-03-04
  Class II
• Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acqui

  EBI, LLC · Devices · 2024-03-22
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000508;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• CryoValve SG Cryopreserved Pulmonary Human Heart Valve

  Artivion, Inc · Devices · 2024-03-06
  Class II
• Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individua

  Blue Ortho · Devices · 2024-08-30
  Class II
• Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W

  Augustine Temperature Management, LLC · Devices · 2024-12-04
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by tra

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product

  Electro Medical Systems SA · Devices · 2024-03-13
  Class II
• Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-11-22
  Class II
• First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

  First Source Inc · Devices · 2024-05-09
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001315;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• OES 4000 Hysteroscope, Model/Catalog Number: A4674A

  Olympus Corporation of the Americas · Devices · 2024-04-18
  Class II
• MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-04-15
  Class II
• Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Des

  CooperSurgical, Inc. · Devices · 2024-11-15
  Class II
• Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Descripti

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-01-02
  Class II
• Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-07-26
  Class II
• ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pac

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, Y

  YAMAHA MOTOR CORPORATION · Devices · 2024-04-17
  Class II
• AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Smaxel Fractional CO2 Laser, a Class IV medical laser system.

  IDS LTD · Devices · 2024-10-16
  Class II
• KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001634;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Num

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-02
  Class II
• POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur

  Olympus Corporation of the Americas · Devices · 2024-03-07
  Class II
• Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

  Medtronic Perfusion Systems · Devices · 2024-12-12
  Class II
• Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemosta

  Wilson-Cook Medical Inc. · Devices · 2024-08-29
  Class II
• IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-04-23
  Class II
• dS Breast 16ch 3.0T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices

  BALT USA, LLC · Devices · 2024-01-03
  Class II
• Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001

  SEASPINE ORTHOPEDICS CORPORATION · Devices · 2024-10-29
  Class II
• Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A

  CooperSurgical, Inc. · Devices · 2024-02-16
  Class II
• ST SENSE Breast Coil

  Philips North America Llc · Devices · 2024-11-04
  Class II
• The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Devices · 2024-09-06
  Class II
• IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement

  Voco GmbH · Devices · 2024-01-25
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584630;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with di

  Integra LifeSciences Corp. · Devices · 2024-05-07
  Class II
• FoundationOne Companion Diagnostic (F1CDx)

  Foundation Medicine, Inc. · Devices · 2024-06-18
  Class II
• BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Colonoscope, Model Number PCF-H190L.

  Olympus Corporation of the Americas · Devices · 2024-01-11
  Class II
• Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTUR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS7600

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-05-07
  Class II
• KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemody

  GE Medical Systems Information Technologies Inc · Devices · 2024-04-22
  Class II
• Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-09-04
  Class II
• Alinity i Anti-HCV Reagent Kit, List Number 08P0521

  Abbott GmbH · Devices · 2024-03-04
  Class II
• Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Con

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ90

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-06-27
  Class II
• CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain

  Integra LifeSciences Corp. · Devices · 2024-05-07
  Class II
• BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Impella 5.5 Set AU; Product Code: 1000361;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KEL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Philips Zenition 70, Model Number: 718133

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2024-10-07
  Class II
• GM60A. Digital Diagnostic Mobile X-Ray System.

  NeuroLogica Corporation · Devices · 2024-07-08
  Class II
• Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2024-05-10
  Class II
• Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the

  DKK Dai-Ichi Shomei Co., Ltd. · Devices · 2024-07-09
  Class II
• Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version:

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

  Olympus Corporation of the Americas · Devices · 2024-05-31
  Class II
• Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

  CooperSurgical, Inc. · Devices · 2024-07-31
  Class II
• BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624

  Becton Dickinson & Co. · Devices · 2024-10-31
  Class II
• USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x1

  United Orthopedic Corporation · Devices · 2024-01-03
  Class II
• Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728

  Philips North America Llc · Devices · 2024-04-15
  Class II
• SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

  Angiodynamics, Inc. · Devices · 2024-06-18
  Class II
• Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractu

  Synthes (USA) Products LLC · Devices · 2024-01-24
  Class II
• Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Ingenia 1.5T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9

  CareFusion 303, Inc. · Devices · 2024-06-24
  Class II
• Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009;

  GE Healthcare · Devices · 2024-07-23
  Class II
• Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drai

  Cook Incorporated · Devices · 2024-05-15
  Class II
• BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and

  CareFusion 303, Inc. · Devices · 2024-02-23
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) ST

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• American Contract Systems Gyn Laparoscopy convenience kit

  American Contract Systems, Inc. · Devices · 2024-05-06
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550

  Canon Medical System, USA, INC. · Devices · 2024-01-29
  Class II
• Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

  FUJIFILM Healthcare Americas Corporation · Devices · 2024-04-11
  Class II
• DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

  DeRoyal Industries Inc · Devices · 2024-10-03
  Class II
• Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tiss

  Ethicon, LLC · Devices · 2024-12-20
  Class II
• Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physician

  Boston Scientific Corporation · Devices · 2024-06-27
  Class II
• Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an int

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indic

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance

  Becton, Dickinson and Company, BD Bio Sciences · Devices · 2024-11-01
  Class II
• Shimadzu, Trinias, Digital Angiography System

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Devices · 2024-01-29
  Class II
• SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in

  Integra LifeSciences Corp. · Devices · 2024-09-20
  Class II
• A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594

  Medtronic Neuromodulation · Devices · 2024-05-15
  Class II
• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

  Howmedica Osteonics Corp. · Devices · 2024-02-06
  Class II
• Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-18
  Class II
• DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo

  Angiodynamics, Inc. · Devices · 2024-03-18
  Class II
• Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number

  Agilent Technologies · Devices · 2024-04-02
  Class II
• Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

  Covidien, LP · Devices · 2024-02-28
  Class II
• Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Ster

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting h

  Siemens Medical Solutions USA, Inc · Devices · 2024-07-03
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicate

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swa

  Becton Dickinson & Co. · Devices · 2024-05-07
  Class II
• Mammotrak Interventional Coil 1.5T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

  Murata Vios, Inc. · Devices · 2024-04-22
  Class II
• LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V u

  Olympus Corporation of the Americas · Devices · 2024-12-16
  Class II
• Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Prod

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I

  Ethicon, Inc. · Devices · 2024-03-08
  Class II
• MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

  Abbott Medical · Devices · 2024-05-16
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M,

  Sklar Instruments · Devices · 2024-12-03
  Class II
• MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and r

  NxStage MDS Corporation · Devices · 2024-01-29
  Class II
• MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-08-28
  Class II
• SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMS

  Medtronic Neuromodulation · Devices · 2024-11-21
  Class II
• MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

  Abbott Medical · Devices · 2024-02-05
  Class II
• Vanta Implantable Neurostimulator (INS), Model 977006

  Medtronic Neuromodulation · Devices · 2024-08-21
  Class II
• Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal he

  Philips North America Llc · Devices · 2024-05-22
  Class II
• IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-04-23
  Class II
• BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

  Becton Dickinson & Co. · Devices · 2024-07-09
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;

  Cardinal Health 200, LLC · Devices · 2024-07-24
  Class II
• ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A

  Sklar Instruments · Devices · 2024-12-03
  Class II
• BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal car

  Maquet Medical Systems USA · Devices · 2024-01-08
  Class II
• GYROSCAN T10-NT, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Intera 3.0T Quasar Dual, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DC

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Out

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only

  MicroPort Orthopedics Inc. · Devices · 2024-05-03
  Class II
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338

  QUIDEL ORTHO · Devices · 2024-12-05
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In

  Merit Medical Systems, Inc. · Devices · 2024-08-30
  Class II
• Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03;

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicat

  Zimmer, Inc. · Devices · 2024-03-20
  Class II
• OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D

  OrganOx Ltd · Devices · 2024-10-15
  Class II
• Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is

  Philips Medical Systems Technologies Ltd. · Devices · 2024-10-10
  Class II
• Ingenia 1.5T S Model Number (REF): 781347

  Philips North America Llc · Devices · 2024-05-03
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000803;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-16
  Class II
• Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Descripti

  CooperSurgical, Inc. · Devices · 2024-11-15
  Class II
• Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

  Karl Storz Endoscopy · Devices · 2024-12-19
  Class II
• 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Arthroscopy Pack, MSKA45A; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide thro

  Medical Depot Inc. · Devices · 2024-06-14
  Class II
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Ped

  BioFire Diagnostics, LLC · Devices · 2024-01-26
  Class II
• Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Ingenia 3.0T, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• Ingenia Ambition S, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self E

  3M Unitek Corporation · Devices · 2024-11-26
  Class II
• MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, ca

  Boston Scientific Corporation · Devices · 2024-09-06
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination o

  Beckman Coulter, Inc. · Devices · 2024-09-30
  Class II
• BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, P

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) D

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene

  Becton Dickinson & Co. · Devices · 2024-02-29
  Class II
• Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile sy

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

  LivaNova Deutschland GmbH · Devices · 2024-10-18
  Class II
• ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled

  Wipro GE Healthcare Private Ltd. · Devices · 2024-08-09
  Class II
• Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

  Quidel Corporation · Devices · 2024-03-05
  Class II
• Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syring

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

  Smiths Medical ASD, Inc. · Devices · 2024-09-24
  Class II
• ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating l

  Zoll Medical Corporation · Devices · 2024-05-31
  Class II
• Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM

  Exactech, Inc. · Devices · 2024-12-31
  Class II
• Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123

  Karl Storz Endoscopy · Devices · 2024-07-23
  Class II
• AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Produ

  Alcon Research LLC · Devices · 2024-07-15
  Class II
• Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou

  Cook Incorporated · Devices · 2024-03-01
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Len

  Maquet Cardiovascular, LLC · Devices · 2024-05-31
  Class II
• Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ;

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

  Atrium Medical Corporation · Devices · 2024-05-03
  Class II
• BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susce

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device int

  Biointellisense Inc. · Devices · 2024-07-19
  Class II
• AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Mode

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

  Wilson-Cook Medical Inc. · Devices · 2024-10-31
  Class II
• MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS76005

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-09
  Class II
• Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

  B Braun Medical Inc · Devices · 2024-05-17
  Class II
• RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it

  Smith & Nephew Medical, Ltd. · Devices · 2024-03-11
  Class II
• Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

  Abiomed, Inc. · Devices · 2024-08-05
  Class II
• Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Steri

  Jiangsu Shenli Medical Production Co., Ltd. · Devices · 2024-04-05
  Class II
• Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 m

  Spectranetics Corporation · Devices · 2024-11-25
  Class II
• SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.

  Philips North America · Devices · 2024-01-03
  Class II
• BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 2316

  Becton Dickinson & Co. · Devices · 2024-01-08
  Class II
• Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

  Cook Biotech, Inc. · Devices · 2024-08-07
  Class II
• Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s

  Hologic Inc · Devices · 2024-08-19
  Class II
• Mammotrak Diagnostic Coil 3.0T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386

  Baxter Healthcare Corporation · Devices · 2024-09-19
  Class II
• Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

  Adept Medical Ltd · Devices · 2024-11-24
  Class II
• CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provid

  Integra LifeSciences Corp. · Devices · 2024-12-16
  Class II
• VITROS XT 3400 Chemistry System, Catalog No. 6844458

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-01-26
  Class II
• GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Devices · 2024-12-18
  Class II
• ViewPoint; system, imaging processing, radiological

  GE Healthcare GmbH · Devices · 2024-08-08
  Class II
• Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BAS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous

  Cook Incorporated · Devices · 2024-05-15
  Class II
• EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

  Medtronic Inc. · Devices · 2024-04-16
  Class II
• Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0

  Cook Incorporated · Devices · 2024-03-01
  Class II
• Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Achieva 3.0T TX for PET Model Number (REF): 781479

  Philips North America Llc · Devices · 2024-05-03
  Class II
• C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod

  Microtek Medical Inc. · Devices · 2024-06-03
  Class II
• Philips IntelliSpace Cardiovascular software, Model 830089.

  Philips Medical Systems Nederland B.V. · Devices · 2024-04-04
  Class II
• GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

  GE Vingmed Ultrasound As · Devices · 2024-05-02
  Class II
• CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be use

  Integra LifeSciences Corp. · Devices · 2024-05-07
  Class II
• Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Pro

  B Braun Medical Inc · Devices · 2024-06-14
  Class II
• KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A

  American Contract Systems Inc · Devices · 2024-05-15
  Class II
• KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE P

  Biocare Medical, LLC · Devices · 2024-09-25
  Class II
• Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch

  Silex Medical, LLC · Devices · 2024-01-09
  Class II
• DCA Systems HbA1c Reagent Kit

  Siemens Healthcare Diagnostics, Inc. · Devices · 2024-02-07
  Class II
• Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 R

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

  Intuitive Surgical, Inc. · Devices · 2024-12-19
  Class II
• Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho

  CareFusion 303, Inc. · Devices · 2024-02-23
  Class II
• OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32

  Exactech, Inc. · Devices · 2024-04-18
  Class II
• Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products

  Microtek Medical Inc. · Devices · 2024-06-03
  Class II
• AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

  Boston Scientific Corporation · Devices · 2024-12-20
  Class II
• Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

  B Braun Medical Inc · Devices · 2024-05-17
  Class II
• Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr.

  Medtronic Perfusion Systems · Devices · 2024-03-19
  Class II
• ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pr

  Smith & Nephew Inc. · Devices · 2024-08-12
  Class II
• SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contai

  The Metrix Company · Devices · 2024-10-09
  Class II
• Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is

  Olympus Corporation of the Americas · Devices · 2024-09-24
  Class II
• Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ90500

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Open Shoulder, LWOS39L; Medical convenience kit

  American Contract Systems, Inc. · Devices · 2024-08-07
  Class II
• Acrobat-i Positioner. Model Number C-XP-5000Z

  Maquet Cardiovascular, LLC · Devices · 2024-10-16
  Class II
• MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the v

  Angiodynamics, Inc. · Devices · 2024-01-30
  Class II
• KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.

  King Systems Corp. dba Ambu, Inc. · Devices · 2024-09-26
  Class II
• Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-03-22
  Class II
• Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL

  Mckesson Medical-Surgical Inc. Corporate Office · Devices · 2024-01-09
  Class II
• MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

  Getinge Usa Sales Inc · Devices · 2024-10-03
  Class II
• Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

  Exactech, Inc. · Devices · 2024-03-06
  Class II
• Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the b

  Integra LifeSciences Corp. · Devices · 2024-01-19
  Class II
• AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

  Integra LifeSciences Corp. · Devices · 2024-06-07
  Class II
• Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargea

  Medtronic Neuromodulation · Devices · 2024-09-18
  Class II
• Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devi

  Philips North America Llc · Devices · 2024-05-03
  Class II
• Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-02-23
  Class II
• ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF:

  Siemens Medical Solutions USA, Inc. · Devices · 2024-02-23
  Class II
• URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-10-23
  Class II
• Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus

  Merit Medical Systems, Inc. · Devices · 2024-06-11
  Class II
• Achieva TX Interventional Coil 3.0T

  Philips North America Llc · Devices · 2024-11-04
  Class II
• Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

  GE Medical Systems, LLC · Devices · 2024-06-14
  Class II
• WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX

  W L Gore & Associates, Inc. · Devices · 2024-07-01
  Class II
• SW Bari Lift & Transfer, Model Number 38060000

  Raye's Inc. · Devices · 2024-01-25
  Class II
• Soltive Pro SuperPulsed Laser System, Model TFL-SLS

  Olympus Corporation of the Americas · Devices · 2024-05-31
  Class II
• Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples

  Biocartis Nv · Devices · 2024-12-10
  Class II
• Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Numbe

  Cardinal Health 200, LLC · Devices · 2024-11-08
  Class II
• Intera 1.5T Master/Nova, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324

  CareFusion 303, Inc. · Devices · 2024-04-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001467;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-11-21
  Class II
• Halyard EP PACK - Medical convenience kits Model Number: VANW018-06

  AVID Medical, Inc. · Devices · 2024-09-20
  Class II
• OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-

  Exactech, Inc. · Devices · 2024-04-18
  Class II
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an int

  Boston Scientific Corporation · Devices · 2024-09-05
  Class II
• Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-08
  Class II
• Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaT

  Covidien LP · Devices · 2024-03-15
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Ingenia 3.0T CX, Magnetic Resonance System.

  Philips North America Llc · Devices · 2024-03-12
  Class II
• BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001631;

  Beaver Visitec International, Inc. · Devices · 2024-07-26
  Class II
• Hemostasis Probe, Model: CD-B622LA

  Olympus Corporation of the Americas · Devices · 2024-01-05
  Class II
• MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2024-04-30
  Class II
• 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of b

  Stryker Corporation · Devices · 2024-09-05
  Class II
• AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

  Boston Scientific Corporation · Devices · 2024-08-01
  Class II
• Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx

  Direct Rx · Drugs · 2023-03-22
  Class II
• Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Ox

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL C

  SCA Pharmaceuticals · Drugs · 2023-07-20
  Class II
• Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per cas

  Fisher Scientific Co., LLC · Drugs · 2023-01-17
  Class II
• EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 220

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Indu

  The Harvard Drug Group · Drugs · 2023-06-16
  Class II
• Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, R

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12

  SterRx, LLC · Drugs · 2023-07-07
  Class II
• Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60

  Apotex Corp. · Drugs · 2023-11-01
  Class II
• Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutical

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2023-05-30
  Class II
• NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, In

  Fagron, Inc · Drugs · 2023-12-11
  Class II
• FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Ap

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Ph

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor

  Ascend Laboratories, LLC · Drugs · 2023-01-05
  Class II
• Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ

  BIOCON PHARMA INC · Drugs · 2023-01-31
  Class II
• Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Di

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, R

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. C

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-12-04
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admix

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook R

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 5

  Alvogen, Inc · Drugs · 2023-02-06
  Class II
• vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 So

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, A

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehe

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compoundi

  New England Life Care, Inc. dba Advanced Compounding Solutions · Drugs · 2023-07-10
  Class II
• Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Inc

  Denison Pharmaceuticals, LLC · Drugs · 2023-05-03
  Class II
• BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (

  CareFusion 213, LLC · Drugs · 2023-08-25
  Class II
• Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-0

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 6063

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl

  HUMANRACE · Drugs · 2023-08-18
  Class II
• vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Ser

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90;

  Golden State Medical Supply Inc. · Drugs · 2023-11-10
  Class II
• morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61

  Direct Rx · Drugs · 2023-03-13
  Class II
• labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Win

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: P

  Pharma Nobis LLC · Drugs · 2023-12-21
  Class II
• fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 79

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Lt

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2023-10-19
  Class II
• Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-10-20
  Class II
• Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz,

  Pharma Nobis LLC · Drugs · 2023-12-21
  Class II
• Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway,

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-coun

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-cou

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle,

  HUMANRACE · Drugs · 2023-08-18
  Class II
• Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., G

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tona

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: D

  Direct Rx · Drugs · 2023-03-13
  Class II
• fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products

  Dr. Berne's Whole Health Products · Drugs · 2023-08-26
  Class II
• Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703,

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharm

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pha

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharma

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Ro

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Centra

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 6

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Col

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-

  Amerisource Health Services LLC · Drugs · 2023-03-17
  Class II
• Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bo

  K.C. Pharmaceuticals, Inc · Drugs · 2023-06-13
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippa

  Teva Pharmaceuticals USA Inc · Drugs · 2023-07-05
  Class II
• potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC.,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets

  Family Dollar Stores, Llc. · Drugs · 2023-03-31
  Class II
• Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72

  Direct Rx · Drugs · 2023-03-22
  Class II
• HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, S

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703,

  Accord Healthcare, Inc. · Drugs · 2023-01-12
  Class II
• heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Service

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775

  Parker Laboratories, Inc. · Drugs · 2023-08-02
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratori

  Padagis US LLC · Drugs · 2023-11-01
  Class II
• TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclus

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,

  Fagron, Inc · Drugs · 2023-12-11
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Adm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Inno

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B

  B. Braun Medical Inc · Drugs · 2023-03-01
  Class II
• NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, I

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methap

  Methapharm Inc · Drugs · 2023-04-07
  Class II
• Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenrid

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-27
  Class II
• Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct

  Direct Rx · Drugs · 2023-03-13
  Class II
• PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharma

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low calcium and HEPARIN, packaged in 250 mL per b

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste

  New England Life Care, Inc. dba Advanced Compounding Solutions · Drugs · 2023-07-10
  Class II
• Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manuf

  AVKARE LLC · Drugs · 2023-08-11
  Class II
• Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Cent

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,00

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx O

  Baxter Healthcare Corporation · Drugs · 2023-08-11
  Class II
• PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admix

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottle

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharma

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-01-16
  Class II
• HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy S

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/m

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged i

  SterRx, LLC · Drugs · 2023-07-07
  Class II
• fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-05-03
  Class II
• Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intr

  Sofie Co dba Sofie · Drugs · 2023-08-22
  Class II
• PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Roa

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Ad

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labora

  Ascend Laboratories, LLC · Drugs · 2023-01-05
  Class II
• BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b)

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Ad

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific:

  Fisher Scientific Co., LLC · Drugs · 2023-01-17
  Class II
• Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia,

  Nephron Sc Inc · Drugs · 2023-02-23
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Centra

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy S

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volum

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2023-09-21
  Class II
• Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM

  Dr. Berne's Whole Health Products · Drugs · 2023-08-26
  Class II
• EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 10

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, In

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7

  Endo Pharmaceuticals, Inc. · Drugs · 2023-03-02
  Class II
• Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 0

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-07-10
  Class II
• phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 10

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279

  Aurobindo Pharma USA Inc. · Drugs · 2023-07-21
  Class II
• Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, C

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repa

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akor

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, ND

  B. Braun Medical Inc. · Drugs · 2023-02-10
  Class II
• Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc.

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured f

  Baxter Healthcare Corporation · Drugs · 2023-08-24
  Class II
• Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx on

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare L

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2023-10-19
  Class II
• Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Leh

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklaho

  PD-Rx Pharmaceuticals, Inc. · Drugs · 2023-04-06
  Class II
• Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Ph

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwa

  Glenmark Therapeutics, Inc. · Drugs · 2023-05-01
  Class II
• allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60

  Apotex Corp. · Drugs · 2023-03-01
  Class II
• TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pha

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- d

  Integrity Bio-Chemicals LLC · Drugs · 2023-10-18
  Class II
• HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bo

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compa

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-02-21
  Class II
• Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearm

  AVKARE LLC · Drugs · 2023-08-11
  Class II
• vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not

  The Ritedose Corporation · Drugs · 2023-07-21
  Class II
• CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixt

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27

  Accord Healthcare, Inc. · Drugs · 2023-07-03
  Class II
• AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use On

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD

  Lupin Pharmaceuticals Inc. · Drugs · 2023-11-22
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total v

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, N

  B. Braun Medical Inc. · Drugs · 2023-02-10
  Class II
• HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only,

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, P

  HTO Nevada, Inc. · Drugs · 2023-02-09
  Class II
• Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Containe

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials,

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By

  Direct Rx · Drugs · 2023-03-13
  Class II
• Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, I

  Sagent Pharmaceuticals Inc · Drugs · 2023-05-19
  Class II
• PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusivel

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991

  Breckenridge Pharmaceutical, Inc · Drugs · 2023-03-02
  Class II
• Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#

  Apotex Corp. · Drugs · 2023-11-01
  Class II
• Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 6004

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663

  RISING PHARMACEUTICALS · Drugs · 2023-02-15
  Class II
• Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-coun

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Containe

  Baxter Healthcare Corporation · Drugs · 2023-08-11
  Class II
• NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceuti

  Nutraceutical Corporation · Drugs · 2023-02-23
  Class II
• Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam -

  Dr Reddy's Laboratories Limited · Drugs · 2023-06-21
  Class II
• Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.

  Urban Electric Power · Drugs · 2023-01-17
  Class II
• Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Centr

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W.

  AnazaoHealth Corporation · Drugs · 2023-11-22
  Class II
• vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snow

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, ND

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-02-21
  Class II
• Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Servi

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower

  Empower Clinic Services LLC dba Empower Pharmacy · Drugs · 2023-05-12
  Class II
• PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90;

  Golden State Medical Supply Inc. · Drugs · 2023-11-10
  Class II
• Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12

  SterRx, LLC · Drugs · 2023-07-07
  Class II
• Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2023-10-27
  Class II
• AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Fo

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant,

  Seaway Pharma Inc. · Drugs · 2023-12-28
  Class II
• fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Phar

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusive

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 1

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Di

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CV

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compou

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals US

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS

  Pharmacy Plus, Inc. dba Vital Care Compounder · Drugs · 2023-04-13
  Class II
• Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture P

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 m

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewa

  Sanofi-Aventis U.S. LLC · Drugs · 2023-04-11
  Class II
• Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Ph

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, S

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplet

  Family Dollar Stores, Llc. · Drugs · 2023-03-31
  Class II
• oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, C

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

  Biomic Sciences, LLC dba ION Intelligence of Nature · Drugs · 2023-09-29
  Class II
• Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by:

  Ascend Laboratories, LLC · Drugs · 2023-07-11
  Class II
• CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 793

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 22

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for

  Legacy Pharmaceutical Packaging LLC · Drugs · 2023-12-11
  Class II
• EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 188

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture P

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharma

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Op

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Centra

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 6878

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pha

  PD-Rx Pharmaceuticals, Inc. · Drugs · 2023-04-06
  Class II
• Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.

  Marlex Pharmaceuticals, Inc. · Drugs · 2023-08-25
  Class II
• Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampul

  Viatris Inc · Drugs · 2023-05-25
  Class II
• Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. AL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Adm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admi

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc.,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc.,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Se

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianap

  Leadiant Biosciences, Inc. · Drugs · 2023-02-03
  Class II
• Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,

  Noven Pharmaceuticals Inc · Drugs · 2023-03-10
  Class II
• CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx On

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) b

  Boehringer Ingelheim Pharmaceuticals, Inc. · Drugs · 2023-03-09
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, IV Bag, Total Volume =

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Centra

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC

  Apotex Corp. · Drugs · 2023-11-01
  Class II
• CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, Sa

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 10

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Servic

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal ap

  Ferring Pharmaceuticals Inc · Drugs · 2023-06-12
  Class II
• Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-cou

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per ba

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, C

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 840

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1

  Breckenridge Pharmaceutical, Inc · Drugs · 2023-03-02
  Class II
• Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc.

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-07-13
  Class II
• Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Pa

  Alpha Aromatics · Drugs · 2023-05-16
  Class II
• Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, I

  Sagent Pharmaceuticals · Drugs · 2023-07-11
  Class II
• Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,0

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indian

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 75

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gur

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare,

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 450

  Nephron Sc Inc · Drugs · 2023-01-12
  Class II
• Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.

  Consolidated Chemical, Inc · Drugs · 2023-01-10
  Class II
• Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61

  Direct Rx · Drugs · 2023-03-13
  Class II
• VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, I

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron

  Nephron Sterile Compounding Center LLC · Drugs · 2023-01-06
  Class II
• HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuti

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Ch

  Seaway Pharma Inc. · Drugs · 2023-12-28
  Class II
• vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Fores

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Cent

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Ma

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM

  Dr. Berne's Whole Health Products · Drugs · 2023-08-26
  Class II
• PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated

  PD-Rx Pharmaceuticals, Inc. · Drugs · 2023-04-06
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 5199

  Breckenridge Pharmaceutical, Inc · Drugs · 2023-03-02
  Class II
• Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118

  Denison Pharmaceuticals, LLC · Drugs · 2023-05-03
  Class II
• NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp.,

  Nutraceutical Corporation · Drugs · 2023-02-23
  Class II
• Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmac

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixtu

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Phar

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61

  Direct Rx · Drugs · 2023-03-13
  Class II
• BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

  Omega & Delta Co., Inc. · Drugs · 2023-10-20
  Class II
• Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefille

  Padagis US LLC · Drugs · 2023-09-28
  Class II
• Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-0

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Sn

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Phar

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmi

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500

  Dr. Reddy's Laboratories, Inc. · Drugs · 2023-02-08
  Class II
• SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd.,

  Ascend Laboratories, LLC · Drugs · 2023-12-29
  Class II
• Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6)

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-27
  Class II
• Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: D

  Direct Rx · Drugs · 2023-03-13
  Class II
• Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Cen

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapo

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating C

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, I

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SC

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) dr

  Integrity Bio-Chemicals LLC · Drugs · 2023-10-18
  Class II
• DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega

  Omega & Delta Co., Inc. · Drugs · 2023-10-20
  Class II
• Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd.,

  Ascend Laboratories, LLC · Drugs · 2023-03-14
  Class II
• Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, G

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-11-07
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total vol

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 220

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For I

  Eugia US LLC · Drugs · 2023-09-28
  Class II
• Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurne

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophiliz

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufac

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ

  Urban Electric Power · Drugs · 2023-01-17
  Class II
• potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 65

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-00

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 m

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, N

  Dr. Berne's Whole Health Products · Drugs · 2023-08-26
  Class II
• HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC619

  Direct Rx · Drugs · 2023-03-13
  Class II
• Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for I

  ITF PHARMA INC · Drugs · 2023-10-20
  Class II
• Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) dr

  Integrity Bio-Chemicals LLC · Drugs · 2023-10-18
  Class II
• Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusive

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questi

  Nutraceutical Corporation · Drugs · 2023-02-23
  Class II
• Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutan

  Sagent Pharmaceuticals Inc · Drugs · 2023-02-28
  Class II
• CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixtu

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Servic

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 8

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-10-20
  Class II
• oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Sn

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe,

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribut

  Global Pharma Healthcare Private Limited · Drugs · 2023-01-30
  Class II
• heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only,

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufac

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constituti

  New England Life Care, Inc. dba Advanced Compounding Solutions · Drugs · 2023-07-10
  Class II
• Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, S

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe,

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, L

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Phar

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratori

  Teva Pharmaceuticals USA Inc · Drugs · 2023-02-22
  Class II
• CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmac

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 River

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (

  Parker Laboratories, Inc. · Drugs · 2023-08-02
  Class II
• Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health

  Safecor Health, LLC · Drugs · 2023-10-19
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B.

  B. Braun Medical Inc · Drugs · 2023-05-09
  Class II
• Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Sn

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc.,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 519

  Breckenridge Pharmaceutical, Inc · Drugs · 2023-03-02
  Class II
• Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmac

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutane

  Sun Pharmaceutical Industries Ltd. · Drugs · 2023-04-19
  Class II
• Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By:

  Direct Rx · Drugs · 2023-03-13
  Class II
• Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only,

  Apollo Care · Drugs · 2023-02-08
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsou

  SSM Health Care St. Louis DBA SSM St. Clare Health Center · Drugs · 2023-05-09
  Class II
• Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-05-30
  Class II
• Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, S

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 068

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL v

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703,

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,

  Noven Pharmaceuticals Inc · Drugs · 2023-03-10
  Class II
• dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, I

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-10-20
  Class II
• fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 696

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101,

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMA

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, R

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Scie

  Strides Pharma Inc. · Drugs · 2023-06-26
  Class II
• CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy

  Pharma Nobis LLC · Drugs · 2023-12-21
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admix

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton,

  Dr. Reddy's Laboratories, Inc. · Drugs · 2023-10-13
  Class II
• Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Labor

  Ascend Laboratories, LLC · Drugs · 2023-01-05
  Class II
• Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottle

  Family Dollar Stores, Llc. · Drugs · 2023-03-31
  Class II
• Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon

  Jarman's Midwest Cleaning Systems, Inc. · Drugs · 2023-03-27
  Class II
• Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 6

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixtu

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count

  Direct Rx · Drugs · 2023-03-13
  Class II
• oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distribut

  HTO Nevada, Inc. · Drugs · 2023-02-09
  Class II
• Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplu

  Sagent Pharmaceuticals · Drugs · 2023-07-11
  Class II
• Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare L

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2023-10-19
  Class II
• Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceutical

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) a

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279

  Aurobindo Pharma USA Inc. · Drugs · 2023-07-21
  Class II
• vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hour

  Seaway Pharma Inc. · Drugs · 2023-12-28
  Class II
• oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 Sou

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g)

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 22

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL O

  Seaway Pharma Inc. · Drugs · 2023-12-28
  Class II
• Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-0

  Parker Laboratories, Inc. · Drugs · 2023-08-02
  Class II
• Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med

  Fresenius Medical Care Holdings, Inc. · Drugs · 2023-12-28
  Class II
• Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota

  Denison Pharmaceuticals, LLC · Drugs · 2023-05-03
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by:

  Pharma Nobis LLC · Drugs · 2023-12-21
  Class II
• PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, N

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 1

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmace

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-01-13
  Class II
• Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct.

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by:

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Man

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Barde

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-11-07
  Class II
• vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 56210

  Strides Pharma Inc. · Drugs · 2023-12-29
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manu

  Lupin Pharmaceuticals Inc. · Drugs · 2023-12-20
  Class II
• fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceutical

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclus

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 S

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: C

  Pharma Nobis LLC · Drugs · 2023-04-06
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmac

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.

  Inmar Supply Chain Solutions, LLC · Drugs · 2023-08-14
  Class II
• Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-0

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Roa

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix,

  Pharmedica USA, LLC · Drugs · 2023-02-14
  Class II
• Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle

  Denison Pharmaceuticals, LLC · Drugs · 2023-05-03
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-02-21
  Class II
• Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico

  Omega & Delta Co., Inc. · Drugs · 2023-10-20
  Class II
• Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: A

  Accord Healthcare, Inc. · Drugs · 2023-07-03
  Class II
• StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-0

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grov

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifu

  MEDLINE INDUSTRIES, LP - Northfield · Drugs · 2023-10-04
  Class II
• Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vi

  Nephron Sc Inc · Drugs · 2023-01-12
  Class II
• Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 m

  Global Pharma Healthcare Private Limited · Drugs · 2023-01-30
  Class II
• fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mc

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter He

  Baxter Healthcare Corporation · Drugs · 2023-03-15
  Class II
• ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syrin

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 25

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactur

  Golden State Medical Supply Inc. · Drugs · 2023-05-25
  Class II
• phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 10

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd A

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Vo

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Ph

  Wells Pharma of Houston LLC · Drugs · 2023-11-22
  Class II
• heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture P

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Te

  The Harvard Drug Group · Drugs · 2023-02-23
  Class II
• Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healt

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, I

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, L

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated

  PD-Rx Pharmaceuticals, Inc. · Drugs · 2023-04-06
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pha

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b)

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 So

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pha

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grov

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg

  Aurobindo Pharma USA Inc. · Drugs · 2023-05-22
  Class II
• Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for:

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by:

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

  TMC Acquisitions LLC dba Tailor Made Compounding · Drugs · 2023-08-15
  Class II
• TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusi

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 River

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

  TMC Acquisitions LLC dba Tailor Made Compounding · Drugs · 2023-08-15
  Class II
• PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10;

  Golden State Medical Supply Inc. · Drugs · 2023-11-10
  Class II
• KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ

  KINDER FARMS LLC · Drugs · 2023-11-13
  Class II
• Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volum

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-0

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Compa

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixtu

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by

  Amerisource Health Services LLC · Drugs · 2023-03-16
  Class II
• Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Centra

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Cen

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central A

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Cent

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gur

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC

  Sagent Pharmaceuticals · Drugs · 2023-07-11
  Class II
• vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmac

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL N

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally,

  Dr. Reddy's Laboratories, Inc. · Drugs · 2023-12-15
  Class II
• PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,00

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dun

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc.,

  Apotex Corp. · Drugs · 2023-11-01
  Class II
• Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II

  Baxter Healthcare Corporation · Drugs · 2023-03-15
  Class II
• NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, I

  Fagron, Inc · Drugs · 2023-12-11
  Class II
• HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture P

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA

  Biomic Sciences, LLC dba ION Intelligence of Nature · Drugs · 2023-09-29
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch

  Nephron Sc Inc · Drugs · 2023-01-13
  Class II
• oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc.,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-c

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 921

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Serv

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,0

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverw

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixt

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101,

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,

  Fagron, Inc · Drugs · 2023-12-11
  Class II
• CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volum

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tu

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: Remed

  RemedyRepack Inc. · Drugs · 2023-05-01
  Class II
• Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. -

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, packaged in 250 mL per bag,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Servic

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bott

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounde

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-25

  RemedyRepack Inc. · Drugs · 2023-05-01
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250m

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Adm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA,

  Breckenridge Pharmaceutical, Inc · Drugs · 2023-03-02
  Class II
• Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gur

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Gr

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 6679

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For I

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Centr

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured fo

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharma

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture P

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Ce

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grov

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma In

  STAQ Pharma, Inc. · Drugs · 2023-11-29
  Class II
• Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa

  Fresenius Medical Care Holdings, Inc. · Drugs · 2023-05-23
  Class II
• Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless S

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-27
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,

  Noven Pharmaceuticals Inc · Drugs · 2023-03-10
  Class II
• Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b)

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA,

  Breckenridge Pharmaceutical, Inc · Drugs · 2023-03-02
  Class II
• fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham,

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Gr

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12

  SterRx, LLC · Drugs · 2023-07-07
  Class II
• LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: Remedy

  RemedyRepack Inc. · Drugs · 2023-05-01
  Class II
• oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, I

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,

  Ascend Laboratories, LLC · Drugs · 2023-03-14
  Class II
• ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, S

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25

  Sagent Pharmaceuticals Inc · Drugs · 2023-05-19
  Class II
• neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 S

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distr

  Pharma Nobis LLC · Drugs · 2023-12-21
  Class II
• ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road,

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Servic

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per ba

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formul

  K.C. Pharmaceuticals, Inc · Drugs · 2023-06-13
  Class II
• Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4

  Kramer Laboratories, Inc. · Drugs · 2023-06-23
  Class II
• rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-06-26
  Class II
• CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixt

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 1

  SterRx, LLC · Drugs · 2023-07-07
  Class II
• dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated

  PD-Rx Pharmaceuticals, Inc. · Drugs · 2023-04-06
  Class II
• Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Ro

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 0770

  Private Label Partners, Inc. · Drugs · 2023-12-13
  Class II
• 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352

  B. Braun Medical Inc. · Drugs · 2023-07-05
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Ba

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcar

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127

  Aurobindo Pharma USA Inc. · Drugs · 2023-08-02
  Class II
• DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admix

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 6800

  Amerisource Health Services LLC · Drugs · 2023-03-17
  Class II
• rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distribu

  VistaPharm LLC · Drugs · 2023-08-30
  Class II
• Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixtu

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25

  Hikma Pharmaceuticals USA Inc. · Drugs · 2023-05-11
  Class II
• Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA

  Ascend Laboratories, LLC · Drugs · 2023-03-17
  Class II
• Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials

  BE PHARMACEUTICALS AG · Drugs · 2023-09-05
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy S

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Phar

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn O

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-

  Parker Laboratories, Inc. · Drugs · 2023-08-02
  Class II
• Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Al

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only

  New Vitalis Pharmacy LLC dba New Vitalis Pharmacy · Drugs · 2023-07-13
  Class II
• Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by

  Pine Pharmaceuticals, LLC · Drugs · 2023-10-02
  Class II
• Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-coun

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy S

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 Sout

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceutic

  Hetero USA Inc · Drugs · 2023-03-14
  Class II
• Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx on

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250m

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-L

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distri

  Colgate Palmolive Company · Drugs · 2023-08-10
  Class II
• Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Centr

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/s

  Apotex Corp. · Drugs · 2023-04-26
  Class II
• Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admix

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pha

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,

  Noven Pharmaceuticals Inc · Drugs · 2023-03-10
  Class II
• Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 Sou

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-1

  Amerisource Health Services LLC · Drugs · 2023-03-17
  Class II
• oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 Sou

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 6679

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-10-23
  Class II
• Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and D

  Amerisource Health Services LLC · Drugs · 2023-06-23
  Class II
• Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976

  Preferred Pharmaceuticals, Inc. · Drugs · 2023-03-23
  Class II
• Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC,

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis

  Consolidated Chemical, Inc · Drugs · 2023-01-10
  Class II
• Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02

  Parker Laboratories, Inc. · Drugs · 2023-08-02
  Class II
• Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61

  Direct Rx · Drugs · 2023-03-13
  Class II
• Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer L

  Kramer Laboratories, Inc. · Drugs · 2023-06-23
  Class II
• Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Ad

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharm

  ALEMBIC PHARMACEUTICALS, INC. · Drugs · 2023-06-22
  Class II
• Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and

  Azurity Pharmaceuticals, Inc. · Drugs · 2023-02-15
  Class II
• tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, G

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pv

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2023-12-26
  Class II
• Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Centr

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distrib

  Tenn South Distillery LLC dba Big Machine Distillery · Drugs · 2023-07-10
  Class II
• EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services,

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 m

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 75

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, I

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx,

  Revive Rx LLC dba Revive Rx Pharmacy · Drugs · 2023-05-11
  Class II
• Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY ND

  Homeocare Laboratories, Inc. · Drugs · 2023-06-05
  Class II
• Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-cou

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120

  Northwind Pharmaceuticals LLC · Drugs · 2023-03-16
  Class II
• Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago,

  Astral SteriTech Private Ltd. · Drugs · 2023-05-15
  Class II
• TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I

  IBSA PHARMA INC · Drugs · 2023-01-30
  Class II
• fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg

  SCA Pharmaceuticals, LLC · Drugs · 2023-11-09
  Class II
• Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250m

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC

  Ecometics, Inc. · Drugs · 2023-08-09
  Class II
• PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LL

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-co

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services Inc · Drugs · 2023-07-17
  Class II
• CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixtur

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Service

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 137

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-02-21
  Class II
• Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC

  Direct Rx · Drugs · 2023-03-22
  Class II
• HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc.

  Central Admixture Pharmacy Services Inc · Drugs · 2023-09-21
  Class II
• Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each i

  Nephron Sc Inc · Drugs · 2023-01-13
  Class II
• TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusivel

  AMMAN PHARMACEUTICAL INDUSTRIES · Drugs · 2023-09-01
  Class II
• rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 M

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-08-17
  Class II
• NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nu

  Nutraceutical Corporation · Drugs · 2023-02-23
  Class II
• oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 65

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, C

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufa

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured b

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-cou

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, I

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V

  Nephron Sterile Compounding Center LLC · Drugs · 2023-02-22
  Class II
• Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Cont

  Seatex LLC · Drugs · 2023-04-19
  Class II
• Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Ca

  Family Dollar Stores, Llc. · Drugs · 2023-03-31
  Class II
• Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Ph

  Rising Pharma Holding, Inc. · Drugs · 2023-12-29
  Class II
• Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufact

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Ad

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-07-14
  Class II
• dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy S

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharm

  Central Admixture Pharmacy Services, Inc. · Drugs · 2023-04-28
  Class II
• Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27

  Accord Healthcare, Inc. · Drugs · 2023-02-07
  Class II
• Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation

  Baxter Healthcare Corporation · Drugs · 2023-11-14
  Class II
• Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by

  Ecometics, Inc. · Drugs · 2023-02-24
  Class II
• Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

  Dollar Tree Distribution, Inc. · Drugs · 2023-10-05
  Class II
• Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25

  Sagent Pharmaceuticals Inc · Drugs · 2023-05-19
  Class II
• Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave.

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine

  Teva Pharmaceuticals USA Inc · Drugs · 2023-02-23
  Class II
• Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by

  Amerisource Health Services LLC · Drugs · 2023-01-27
  Class II
• Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-c

  Amerisource Health Services LLC · Drugs · 2023-01-11
  Class II
• PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compoundi

  New England Life Care, Inc. dba Advanced Compounding Solutions · Drugs · 2023-07-10
  Class II
• Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Fa

  Family Medical Supply Inc · Drugs · 2023-11-09
  Class II
• VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 10

  Apollo Care, LLC · Drugs · 2023-05-02
  Class II
• KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (11

  KINDER FARMS LLC · Drugs · 2023-11-13
  Class II
• aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Per

  L. Perrigo Company · Drugs · 2023-02-09
  Class II
• B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML St

  AnazaoHealth Corporation · Drugs · 2023-11-22
  Class II
• Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Compan

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, N

  RemedyRepack Inc. · Drugs · 2023-03-20
  Class II
• Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15m

  Akorn, Inc. · Drugs · 2023-04-26
  Class II
• buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceuti

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-05-09
  Class II
• Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-08-03
  Class II
• Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

  Stryker Sustainability Solutions · Devices · 2023-04-14
  Class II
• Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A

  Elekta Instrument AB · Devices · 2023-03-01
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena

  Randox Laboratories Ltd. · Devices · 2023-06-13
  Class II
• VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

  Johnson & Johnson Surgical Vision, Inc. · Devices · 2023-05-30
  Class II
• epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

  Siemens Healthcare Diagnostics Inc · Devices · 2023-06-01
  Class II
• KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e

  Pro-Dex Inc · Devices · 2023-02-14
  Class II
• MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

  Micro-X Ltd. · Devices · 2023-11-28
  Class II
• CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

  Cardinal Health 200, LLC · Devices · 2023-12-21
  Class II
• Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) A

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-03-21
  Class II
• Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural lig

  T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Devices · 2023-05-04
  Class II
• PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1)

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary int

  Zimmer, Inc. · Devices · 2023-06-27
  Class II
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)

  CooperVision, Inc. · Devices · 2023-01-26
  Class II
• V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intende

  Steris Corporation · Devices · 2023-11-16
  Class II
• EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

  Aizu Olympus Co., Ltd. · Devices · 2023-10-16
  Class II
• DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

  Encore Medical, LP · Devices · 2023-08-04
  Class II
• Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

  Pulmonx, Corp. · Devices · 2023-08-31
  Class II
• VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-10-10
  Class II
• nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosi

  Landauer · Devices · 2023-07-12
  Class II
• Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

  Atrium Medical Corporation · Devices · 2023-09-18
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring do

  Landauer · Devices · 2023-07-12
  Class II
• Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation

  Sensus Healthcare, Inc. · Devices · 2023-02-10
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• Azurion 7 M20. X-ray Image guided Therapy System.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-06-12
  Class II
• Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .

  Maquet Cardiovascular, LLC · Devices · 2023-12-01
  Class II
• Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C

  Randox Laboratories Ltd. · Devices · 2023-07-19
  Class II
• Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-04-21
  Class II
• Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant ki

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 888

  Covidien LP · Devices · 2023-12-21
  Class II
• ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844

  Globus Medical, Inc. · Devices · 2023-12-15
  Class II
• Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Nu

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Sensis Vibe Hemo

  Siemens Medical Solutions USA, Inc · Devices · 2023-11-29
  Class II
• Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S

  Elekta, Inc. · Devices · 2023-10-25
  Class II
• EVIS EXERA III Gastrointestinal Videoscope

  Olympus Corporation of the Americas · Devices · 2023-10-02
  Class II
• Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation mon

  Landauer · Devices · 2023-07-12
  Class II
• Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-16
  Class II
• Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pul

  GE MEDICAL SYSTEMS, ISRAEL LTD. · Devices · 2023-09-06
  Class II
• The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO

  Olympus Corporation of the Americas · Devices · 2023-07-12
  Class II
• QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No.

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Atrium Oasis Drain Single W / AC, Part No. 3600-100

  Atrium Medical Corporation · Devices · 2023-11-01
  Class II
• ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qu

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-07-25
  Class II
• 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam ster

  3M Company - Health Care Business · Devices · 2023-08-22
  Class II
• ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele

  Elekta, Inc. · Devices · 2023-10-25
  Class II
• ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #

  Siemens Medical Solutions USA, Inc · Devices · 2023-02-02
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015

  Stryker Corporation · Devices · 2023-09-11
  Class II
• PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica

  Materialise N.V. · Devices · 2023-06-19
  Class II
• BD Pyxis Med ES Auxiliary (AUX), REF 343

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sens

  Siemens Medical Solutions USA, Inc. · Devices · 2023-07-12
  Class II
• Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str

  Visgeneer, Inc. · Devices · 2023-10-04
  Class II
• ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/

  Instrumentation Laboratory · Devices · 2023-02-03
  Class II
• AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

  Avanos Medical, Inc. · Devices · 2023-04-24
  Class II
• DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

  Beckman Coulter, Inc. · Devices · 2023-04-05
  Class II
• Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, l

  Olympus Corporation of the Americas · Devices · 2023-11-20
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in cli

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment o

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

  GE Healthcare · Devices · 2023-09-14
  Class II
• Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2

  Merit Medical Systems, Inc. · Devices · 2023-11-06
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• ASG-001; Ultrasound gel

  Advance Medical Designs, Inc. · Devices · 2023-07-07
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

  Masimo Corporation · Devices · 2023-04-21
  Class II
• Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

  Terumo Cardiovascular Systems Corporation · Devices · 2023-03-01
  Class II
• LAVH, REF BBLV21C

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. No

  Cardiac Assist, Inc · Devices · 2023-06-30
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light

  Olympus Corporation of the Americas · Devices · 2023-09-14
  Class II
• PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

  AMD Medicom Inc. · Devices · 2023-12-21
  Class II
• ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

  Elekta, Inc. · Devices · 2023-10-25
  Class II
• QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR reade

  Landauer · Devices · 2023-07-12
  Class II
• Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controll

  mo-Vis BVBA · Devices · 2023-11-28
  Class II
• STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medica

  Scican Ltd. · Devices · 2023-06-22
  Class II
• Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x

  CareFusion 303, Inc. · Devices · 2023-01-24
  Class II
• Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19

  Olympus Corporation of the Americas · Devices · 2023-08-10
  Class II
• EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr

  Philips North America Llc · Devices · 2023-08-17
  Class II
• Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

  Stryker, Inc. · Devices · 2023-12-06
  Class II
• QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-C

  Qiagen GmbH · Devices · 2023-05-09
  Class II
• LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified p

  Remote Diagnostic Technologies Ltd. · Devices · 2023-02-23
  Class II
• Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

  Philips North America · Devices · 2023-10-09
  Class II
• Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar ene

  Boston Scientific Corporation · Devices · 2023-02-02
  Class II
• Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

  Beckman Coulter, Inc. · Devices · 2023-11-21
  Class II
• EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adult

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

  ACTIM OY · Devices · 2023-11-23
  Class II
• Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR re

  Landauer · Devices · 2023-07-12
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers

  Landauer · Devices · 2023-07-12
  Class II
• LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• VITROS XT Chemistry Products ALKP Slides

  Ortho-Clinical Diagnostics, INc. · Devices · 2023-08-05
  Class II
• Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

  Philips North America Llc · Devices · 2023-09-21
  Class II
• LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for pr

  Linkbio Corp. · Devices · 2023-04-25
  Class II
• Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

  Encore Medical, LP · Devices · 2023-09-06
  Class II
• Multichem P, Part Code 08P90-10

  TECHNO-PATH MANUFACTURING LTD. · Devices · 2023-08-25
  Class II
• Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

  Digisonics, Inc · Devices · 2023-06-26
  Class II
• BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device

  Wright Medical Technology, Inc. · Devices · 2023-02-02
  Class II
• BD Pyxis MedBank MedPass Software, REF: 139088-01

  CareFusion 303, Inc. · Devices · 2023-08-18
  Class II
• Stay Safe Cap

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-10-10
  Class II
• Robotics Pack SAH, REF SAR530M

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

  DePuy Orthopaedics, Inc. · Devices · 2023-02-15
  Class II
• Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement with

  Stryker Corporation · Devices · 2023-08-07
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROB

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIAT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• 50-GEL20; Ultrasound gel

  Advance Medical Designs, Inc. · Devices · 2023-07-07
  Class II
• Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

  Karl Storz Endoscopy · Devices · 2023-07-07
  Class II
• Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

  Landauer · Devices · 2023-11-15
  Class II
• Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code

  Abiomed, Inc. · Devices · 2023-12-27
  Class II
• Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended

  Wilson-Cook Medical Inc. · Devices · 2023-06-22
  Class II
• QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring d

  Landauer · Devices · 2023-07-12
  Class II
• Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,

  Nova Biomedical Corporation · Devices · 2023-09-18
  Class II
• SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX

  Olympus Corporation of the Americas · Devices · 2023-12-01
  Class II
• Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R

  CooperSurgical, Inc. · Devices · 2023-08-29
  Class II
• Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of

  Apellis Pharmaceuticals, Inc. · Devices · 2023-08-22
  Class II
• Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

  Intuitive Surgical, Inc. · Devices · 2023-10-06
  Class II
• LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

  PATH · Devices · 2023-09-26
  Class II
• Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics

  Ellex Medical Pty Ltd. · Devices · 2023-03-16
  Class II
• Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

  Advance Medical Designs, Inc. · Devices · 2023-07-07
  Class II
• Centurion FMS Pak

  Alcon Research, LTD. · Devices · 2023-06-28
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

  Edwards Lifesciences, LLC · Devices · 2023-09-07
  Class II
• MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

  Medacta Usa Inc · Devices · 2023-03-08
  Class II
• 3M Attest Steam Chemical Integrators, REF 1243B

  3M Company - Health Care Business · Devices · 2023-04-06
  Class II
• Coapt Dome Electrode, Gen2 system, cutaneous electrode

  Coapt LLC · Devices · 2023-10-02
  Class II
• MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• Oculus Pentacam AXL , Ref 70100, CE 0123

  Oculus Optikgeraete GMBH · Devices · 2023-08-08
  Class II
• Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-12
  Class II
• STERILE PVP SOLUTION, REF DYNDA1907

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

  Galt Medical Corporation · Devices · 2023-05-08
  Class II
• PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati

  Philips North America Llc · Devices · 2023-10-09
  Class II
• Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S

  Riverpoint Medical, LLC · Devices · 2023-10-25
  Class II
• Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sli

  Maquet Medical Systems USA · Devices · 2023-10-12
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

  Mazor Robotics Ltd · Devices · 2023-09-05
  Class II
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS

  Stryker Corporation · Devices · 2023-03-01
  Class II
• HAMILTON-C6, REF: 160021

  Hamilton Medical AG · Devices · 2023-03-14
  Class II
• Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-A

  Olympus Corporation of the Americas · Devices · 2023-12-04
  Class II
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Intelli-C, Left side suspended Tabletop, REF: 03400010

  NRT X-RAY A/S · Devices · 2023-04-27
  Class II
• LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

  Datascope Corp. · Devices · 2023-06-23
  Class II
• stryker Sage PrimaFit External Urine Management System for the Female Anatomy

  Sage Products Inc · Devices · 2023-10-23
  Class II
• Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

  Wright Medical Technology, Inc. · Devices · 2023-06-13
  Class II
• RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an

  Acumed LLC · Devices · 2023-11-27
  Class II
• SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

  ARROW INTERNATIONAL Inc. · Devices · 2023-08-10
  Class II
• The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE

  BioFire Diagnostics, LLC · Devices · 2023-11-27
  Class II
• SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-11-27
  Class II
• EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Medline Leg bag, REF URO12573

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-10-19
  Class II
• SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

  Townsend Design · Devices · 2023-09-23
  Class II
• Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

  AtriCure, Inc. · Devices · 2023-11-28
  Class II
• Eye and Ear Dropper, Product Code 67082

  Apothecary Products, LLC · Devices · 2023-03-30
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS9

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• DRX Revolution Mobile X-Ray System

  Carestream Health, Inc. · Devices · 2023-10-02
  Class II
• Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a

  Cytocell Ltd. · Devices · 2023-05-24
  Class II
• Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum an

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial i

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in hum

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-27
  Class II
• nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTA

  Landauer · Devices · 2023-07-12
  Class II
• GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

  GE HEALTHCARE AUSTRIA GMBH & CO · Devices · 2023-12-22
  Class II
• Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• MICRO-X Rover Mobile X-ray System, # MXU-RV35

  Micro-X Ltd. · Devices · 2023-05-31
  Class II
• ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibri

  Instrumentation Laboratory · Devices · 2023-02-03
  Class II
• Alinity ci-series System Control Module, REF: 03R70-01

  Abbott Laboratories · Devices · 2023-05-30
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

  Stryker Corporation · Devices · 2023-06-28
  Class II
• Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• STERILE POVIDONE, REF DYNDA2061

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

  Smith & Nephew, Inc. · Devices · 2023-03-27
  Class II
• REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

  Osteomed, LLC · Devices · 2023-05-31
  Class II
• SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aor

  Datascope Corp. · Devices · 2023-06-23
  Class II
• Medline Leg bag, REF DYND12574

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-10-19
  Class II
• Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020

  Remote Diagnostic Technologies Ltd. · Devices · 2023-05-08
  Class II
• CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary art

  St. Jude Medical · Devices · 2023-02-07
  Class II
• Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ve

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resus

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment

  Siemens Medical Solutions USA, Inc · Devices · 2023-09-12
  Class II
• a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, C

  Onkos Surgical, Inc. · Devices · 2023-09-01
  Class II
• APK2 Pressure-Sensing Wheelchair Cushions

  Aquila Corporation · Devices · 2023-07-06
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affecte

  Philips North America Llc · Devices · 2023-06-14
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Olympus Bronchovideoscope, Models BF-3C160.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• GE Healthcare Vivid S60N, ultrasound device

  GE Vingmed Ultrasound As · Devices · 2023-05-30
  Class II
• G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

  Biomet, Inc. · Devices · 2023-02-06
  Class II
• DENTEMP ONE STEP .077OZ, SKU 902139

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A

  CardioQuip, LLC · Devices · 2023-10-24
  Class II
• nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR r

  Landauer · Devices · 2023-07-12
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

  Stryker, Inc. · Devices · 2023-12-06
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-03-10
  Class II
• DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

  BioFire Diagnostics, LLC · Devices · 2023-12-14
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical devic

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Robotics Pack, REF SJVO56B

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85

  Datascope Corp. · Devices · 2023-02-07
  Class II
• QMS Tacrolimus Calibrators, Product code 10015573

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-11-21
  Class II
• Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-07-10
  Class II
• DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

  DermLite LLC · Devices · 2023-03-20
  Class II
• Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media

  Olympus Corporation of the Americas · Devices · 2023-12-11
  Class II
• GS0008 2Y - Burn Pack - STL, Item Number 880082025

  ROi CPS LLC · Devices · 2023-09-11
  Class II
• Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM

  Bard Peripheral Vascular Inc · Devices · 2023-04-11
  Class II
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoles

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Softw

  Philips North America · Devices · 2023-04-19
  Class II
• WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

  Boston Scientific Corporation · Devices · 2023-04-05
  Class II
• VADER pedicle system, torque wrench, Catalog Number 42-702

  Icotec Ag · Devices · 2023-11-28
  Class II
• VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

  Maquet Cardiovascular, LLC · Devices · 2023-03-06
  Class II
• VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains

  Ortho-Clinical Diagnostics, INc. · Devices · 2023-09-12
  Class II
• Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

  Preat Corp · Devices · 2023-02-21
  Class II
• Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

  Atrium Medical Corporation · Devices · 2023-09-05
  Class II
• nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR

  Landauer · Devices · 2023-07-12
  Class II
• Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1

  Angiodynamics, Inc. · Devices · 2023-12-18
  Class II
• PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGT

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

  Medtronic Inc. · Devices · 2023-11-03
  Class II
• Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD5

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

  Boston Scientific Corporation · Devices · 2023-07-11
  Class II
• Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

  XTANT Medical Holdings, Inc · Devices · 2023-11-28
  Class II
• GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500

  Instrumentation Laboratory · Devices · 2023-09-29
  Class II
• Design Options¿ / Epidural anesthesia kit (10 count carton)

  B. Braun Medical, Inc. · Devices · 2023-06-05
  Class II
• Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03

  Onkos Surgical, Inc. · Devices · 2023-09-01
  Class II
• PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

  DePuy Orthopaedics, Inc. · Devices · 2023-02-15
  Class II
• Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025

  Beaver Visitec International, Inc. · Devices · 2023-10-10
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-LE-400.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

  Illumina, Inc. · Devices · 2023-04-05
  Class II
• LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

  CardioQuip, LLC · Devices · 2023-10-19
  Class II
• LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

  Datascope Corp. · Devices · 2023-04-04
  Class II
• LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Incisive CT, software version 5.0

  Philips Healthcare · Devices · 2023-08-02
  Class II
• The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator

  GE Hangwei Medical Systems, Co. LTD · Devices · 2023-11-07
  Class II
• CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary art

  St. Jude Medical · Devices · 2023-02-07
  Class II
• Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT3

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Flow-c Anesthesia System, model 6887700

  Getinge Usa Sales Inc · Devices · 2023-12-11
  Class II
• 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural liga

  T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Devices · 2023-05-04
  Class II
• ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

  Philips North America · Devices · 2023-12-15
  Class II
• DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

  AURIS HEALTH INC · Devices · 2023-10-18
  Class II
• BrightView X, Gamma Camera, Product Code 882478

  Philips North America · Devices · 2023-11-30
  Class II
• SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

  SynCardia Systems LLC · Devices · 2023-08-01
  Class II
• Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removab

  Davol, Inc. · Devices · 2023-04-25
  Class II
• Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrilla

  Abbott Medical · Devices · 2023-08-16
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Legion FMS Pak

  Alcon Research, LTD. · Devices · 2023-06-28
  Class II
• Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2023-11-01
  Class II
• Medtronic SynchroMed II, Model 8637-20, Programmable pump

  Medtronic Neuromodulation · Devices · 2023-11-13
  Class II
• Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

  DePuy Orthopaedics, Inc. · Devices · 2023-02-15
  Class II
• Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

  Corin Ltd · Devices · 2023-10-13
  Class II
• Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P

  Permobil · Devices · 2023-05-10
  Class II
• QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S

  Blue Belt Technologies, Inc · Devices · 2023-11-13
  Class II
• AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage

  Radiometer Medical ApS · Devices · 2023-03-08
  Class II
• Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine P

  Mirion Technologies (Capintec), Inc. · Devices · 2023-11-27
  Class II
• Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a cons

  Stryker Corporation · Devices · 2023-08-07
  Class II
• Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0

  Datascope Corp. · Devices · 2023-02-07
  Class II
• Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Pa

  Intuitive Surgical, Inc. · Devices · 2023-01-24
  Class II
• LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

  Fresenius Kabi USA, LLC · Devices · 2023-05-10
  Class II
• SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERI

  Medtronic Neurosurgery · Devices · 2023-06-28
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

  Baxter Healthcare Corporation · Devices · 2023-02-22
  Class II
• Perifix¿ / Epidural anesthesia set, medicated

  B. Braun Medical, Inc. · Devices · 2023-07-31
  Class II
• EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

  Boston Scientific Corporation · Devices · 2023-09-27
  Class II
• Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each packa

  SenTec AG · Devices · 2023-07-25
  Class II
• Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 0

  Medagent Inc · Devices · 2023-12-21
  Class II
• Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-03-02
  Class II
• PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in

  Ethicon, Inc. · Devices · 2023-03-31
  Class II
• Citrine Triple Quad Mass Spectrometer, Part Number 5063684

  AB Sciex, LLC · Devices · 2023-08-30
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-10-10
  Class II
• Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm

  Securitas Healthcare LLC · Devices · 2023-09-25
  Class II
• Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• DJO EMPOWR Knee Punch Handle, REF: 801-05-040

  Encore Medical, LP · Devices · 2023-09-29
  Class II
• PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ven

  Vyaire Medical · Devices · 2023-10-27
  Class II
• Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 1

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk,

  Remel, Inc · Devices · 2023-05-31
  Class II
• WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)

  Boston Scientific Corporation · Devices · 2023-04-05
  Class II
• GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112;

  GRAPHENANO DENTAL SL · Devices · 2023-10-24
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, frac

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteros

  WOM World Of Medicine AG · Devices · 2023-07-17
  Class II
• BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen

  T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Devices · 2023-05-04
  Class II
• Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

  Karl Storz Endoscopy · Devices · 2023-10-24
  Class II
• Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

  Omega Medical Imaging, Inc. · Devices · 2023-02-28
  Class II
• stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

  Stryker Corporation · Devices · 2023-06-28
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e)

  C.R. Bard Inc · Devices · 2023-04-20
  Class II
• Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

  Elekta, Inc. · Devices · 2023-10-25
  Class II
• Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human se

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-07-10
  Class II
• DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

  Defibtech, LLC · Devices · 2023-02-14
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A

  CardioQuip, LLC · Devices · 2023-10-24
  Class II
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-0

  Datascope Corp. · Devices · 2023-02-28
  Class II
• Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• NexGen Precoat Stemmed Tibial Plate Size 5

  Zimmer, Inc. · Devices · 2023-05-19
  Class II
• Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthropla

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-11-30
  Class II
• MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-03
  Class II
• L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile

  Peter Lazic Gmbh · Devices · 2023-07-14
  Class II
• Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Senographe Pristina

  GE Medical Systems, SCS · Devices · 2023-12-26
  Class II
• Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test r

  Church & Dwight Inc · Devices · 2023-01-25
  Class II
• Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metere

  B. Braun Medical, Inc. · Devices · 2023-08-07
  Class II
• VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-03-10
  Class II
• stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty su

  Howmedica Osteonics Corp. · Devices · 2023-03-10
  Class II
• The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric

  Medtronic Navigation, Inc.-Littleton · Devices · 2023-07-25
  Class II
• The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology

  Carestream Health, Inc. · Devices · 2023-10-02
  Class II
• Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5

  Smiths Medical ASD Inc. · Devices · 2023-12-19
  Class II
• Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bon

  Stryker Corporation · Devices · 2023-08-07
  Class II
• Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

  Medtronic Inc. · Devices · 2023-11-20
  Class II
• Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides health

  Sarnova HC, Llc · Devices · 2023-11-06
  Class II
• TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

  Limacorporate S.p.A · Devices · 2023-01-25
  Class II
• Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer

  Abbott Laboratories · Devices · 2023-10-19
  Class II
• Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, T

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Allura Xper IGTS Fixed Systems

  Philips North America · Devices · 2023-10-04
  Class II
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to

  Siemens Healthcare Diagnostics Inc · Devices · 2023-10-26
  Class II
• Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

  Masimo Corporation · Devices · 2023-04-21
  Class II
• Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mate

  Siemens Medical Solutions USA, Inc · Devices · 2023-06-19
  Class II
• RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

  Randox Laboratories Ltd. · Devices · 2023-09-06
  Class II
• Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Devices · 2023-04-10
  Class II
• QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radi

  Landauer · Devices · 2023-07-12
  Class II
• IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B153340

  Medicrea International · Devices · 2023-07-12
  Class II
• PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olym

  Olympus Corporation of the Americas · Devices · 2023-12-08
  Class II
• Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-

  Hologic, Inc. · Devices · 2023-01-16
  Class II
• Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION

  Atrium Medical Corporation · Devices · 2023-09-05
  Class II
• nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiatio

  Landauer · Devices · 2023-07-12
  Class II
• 4500MD Triple Quad Mass Spectrometer, Part Number 5032522

  AB Sciex, LLC · Devices · 2023-08-30
  Class II
• WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Numb

  Wishbone Medical, Inc. · Devices · 2023-01-04
  Class II
• Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

  Masimo Corporation · Devices · 2023-04-21
  Class II
• FIRST RESPONSE 2 CT, SKU 902343

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

  Medtronic Inc · Devices · 2023-10-12
  Class II
• Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-d

  Karl Storz Endoscopy · Devices · 2023-10-24
  Class II
• epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX)

  Siemens Healthcare Diagnostics Inc · Devices · 2023-10-19
  Class II
• Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w

  Philips Medical Systems Nederland B.V. · Devices · 2023-07-20
  Class II
• Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural lig

  T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Devices · 2023-05-04
  Class II
• VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

  ORTHO-CLINICAL DIAGNOSTICS · Devices · 2023-06-05
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m

  Olympus Corporation of the Americas · Devices · 2023-05-26
  Class II
• Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection

  Karl Storz Endoscopy · Devices · 2023-10-24
  Class II
• Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10

  RAYSEARCH LABORATORIES AB · Devices · 2023-02-17
  Class II
• HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme

  Olympus Corporation of the Americas · Devices · 2023-06-08
  Class II
• Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-03-16
  Class II
• DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

  Encore Medical, LP · Devices · 2023-08-04
  Class II
• YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

  Surgical Innovations Ltd · Devices · 2023-03-28
  Class II
• Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 6362

  Microtek Medical Inc. · Devices · 2023-06-23
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; end

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm,

  Karl Storz Endoscopy · Devices · 2023-04-06
  Class II
• Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

  Medtronic Navigation, Inc. · Devices · 2023-11-28
  Class II
• BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Cod

  Maquet Medical Systems USA · Devices · 2023-02-13
  Class II
• Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

  Encore Medical, LP · Devices · 2023-08-22
  Class II
• Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog

  Olympus Corporation of the Americas · Devices · 2023-05-04
  Class II
• ISee Ortho-K Lens

  PARAGON VISION SCIENCES, Inc · Devices · 2023-06-26
  Class II
• Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS

  Stryker Corporation · Devices · 2023-03-01
  Class II
• OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim

  NeuroLogica Corporation · Devices · 2023-06-06
  Class II
• Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• STERILE BETADINE, REF DYNDA1998

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for s

  Siemens Medical Solutions USA, Inc · Devices · 2023-02-02
  Class II
• Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

  Philips North America · Devices · 2023-12-15
  Class II
• STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

  Stanbio Laboratory, LP · Devices · 2023-10-02
  Class II
• SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human ser

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-27
  Class II
• Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947

  Beckman Coulter, Inc. · Devices · 2023-12-19
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B2024020

  Medicrea International · Devices · 2023-07-12
  Class II
• SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Mod

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Omnipod 5 Automated Insulin Delivery System

  Insulet Corporation · Devices · 2023-02-28
  Class II
• Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

  PHILIPS HEADQUARTERS CAMBRIDGE · Devices · 2023-04-12
  Class II
• Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

  Fujifilm Irvine Scientific, Inc. · Devices · 2023-01-16
  Class II
• Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-

  TriMed Inc. · Devices · 2023-11-28
  Class II
• BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• DiagnosUS Pregnancy Test Midstream REF 100-17

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predeter

  DRE Medical Group Inc · Devices · 2023-05-15
  Class II
• SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbe

  Beckman Coulter, Inc. · Devices · 2023-04-05
  Class II
• BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

  Philips North America · Devices · 2023-10-04
  Class II
• SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-02-20
  Class II
• Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F

  Edwards Lifesciences, LLC · Devices · 2023-02-14
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interv

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy fr

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

  Creganna Medical Devices · Devices · 2023-06-22
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

  Liberty Medical Solutions, LLC · Devices · 2023-11-03
  Class II
• Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Alw

  Olympus Corporation of the Americas · Devices · 2023-08-10
  Class II
• Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-08-15
  Class II
• iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e)

  Beckman Coulter, Inc. · Devices · 2023-12-19
  Class II
• XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS US

  Baxter Healthcare Corporation · Devices · 2023-12-08
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical int

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities

  Tobii Dynavox Llc · Devices · 2023-02-24
  Class II
• ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Mo

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo

  Philips North America Llc · Devices · 2023-10-09
  Class II
• Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization

  Synthes (USA) Products LLC · Devices · 2023-02-01
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• vRad PACS with Mammography

  Virtual Radiologic Corp. · Devices · 2023-05-09
  Class II
• PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCR

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-1412

  Onkos Surgical, Inc. · Devices · 2023-09-01
  Class II
• with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator de

  Breas Medical, Inc. · Devices · 2023-10-13
  Class II
• ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulati

  Instrumentation Laboratory · Devices · 2023-07-13
  Class II
• Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

  Abbott · Devices · 2023-09-28
  Class II
• GS70H Salus Surgical Table, Product Code 18-071-70

  Skytron, LLC · Devices · 2023-08-01
  Class II
• Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

  Smiths Medical ASD Inc. · Devices · 2023-12-19
  Class II
• Universal Viewer Workflow Manager, Image processing radiological system

  GE Healthcare · Devices · 2023-09-08
  Class II
• The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neuro

  Stryker Corporation · Devices · 2023-06-28
  Class II
• Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Mo

  Stryker Medical Division of Stryker Corporation · Devices · 2023-02-01
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Constellation Vision System, REF: 8065751150

  Alcon Research, LLC · Devices · 2023-08-18
  Class II
• VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-03-10
  Class II
• Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

  Ossur H / F · Devices · 2023-12-26
  Class II
• Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• Lugol s Iodine Solution 500ML, Part Number 624-71

  EMD Millipore Corporation · Devices · 2023-10-17
  Class II
• SenSight Connector Plug, Model Number B31061.

  Medtronic Neuromodulation · Devices · 2023-01-20
  Class II
• Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

  ROi CPS LLC · Devices · 2023-09-21
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

  St. Jude Medical, Atrial Fibrillation Division, Inc. · Devices · 2023-12-18
  Class II
• NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and

  NeuMoDx Molecular Inc · Devices · 2023-05-24
  Class II
• Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52;

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-

  HeartSine Technologies Ltd · Devices · 2023-02-01
  Class II
• TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

  Medtronic Sofamor Danek USA, Inc · Devices · 2023-07-12
  Class II
• Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a

  OriGen Biomedical, Inc. · Devices · 2023-12-19
  Class II
• Constellation Procedure Pak

  Alcon Research, LTD. · Devices · 2023-06-28
  Class II
• YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.

  Datascope Corp. · Devices · 2023-06-23
  Class II
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample

  Qiagen GmbH · Devices · 2023-05-19
  Class II
• Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

  Atrium Medical Corporation · Devices · 2023-09-29
  Class II
• Veradius Unity Mobile Surgery C-arm

  Philips North America · Devices · 2023-10-04
  Class II
• Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of s

  Meridian Bioscience Inc · Devices · 2023-10-19
  Class II
• Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT S

  Alcon Research, LLC · Devices · 2023-03-10
  Class II
• Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-08
  Class II
• Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-09
  Class II
• Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

  Encore Medical, LP · Devices · 2023-08-04
  Class II
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In

  BioFire Diagnostics, LLC · Devices · 2023-10-17
  Class II
• PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Cardiosave Rescue. Model Number: 0998-00-0800-83.

  Datascope Corp. · Devices · 2023-02-07
  Class II
• REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx On

  Becton Dickinson Infusion Therapy Systems Inc. · Devices · 2023-08-29
  Class II
• DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port f

  Smiths Medical ASD Inc. · Devices · 2023-04-05
  Class II
• Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.

  Stryker Corporation · Devices · 2023-01-25
  Class II
• RX Series Copper (Cu) Assay Ref. Number CU2340

  Randox Laboratories Ltd. · Devices · 2023-11-29
  Class II
• Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a s

  Maquet Cardiovascular, LLC · Devices · 2023-09-13
  Class II
• Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

  Siemens Medical Solutions USA, Inc · Devices · 2023-09-12
  Class II
• BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, s

  Becton Dickinson & Co. · Devices · 2023-05-01
  Class II
• Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

  PHILIPS MEDICAL SYSTEMS · Devices · 2023-12-13
  Class II
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5

  Medtronic Inc · Devices · 2023-10-12
  Class II
• Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgica

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

  BioFire Diagnostics, LLC · Devices · 2023-04-25
  Class II
• Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El

  Elekta, Inc. · Devices · 2023-05-05
  Class II
• PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.

  Baxter Healthcare Corporation · Devices · 2023-08-10
  Class II
• HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN

  Olympus Corporation of the Americas · Devices · 2023-08-10
  Class II
• TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

  Howmedica Osteonics Corp. · Devices · 2023-04-13
  Class II
• SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

  Stryker Corporation · Devices · 2023-03-02
  Class II
• Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR re

  Landauer · Devices · 2023-07-12
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

  Microbiologics Inc · Devices · 2023-10-18
  Class II
• Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3

  Mani, Inc. - Kiyohara Facility · Devices · 2023-02-20
  Class II
• CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restruct

  RoyalVibe Health Ltd. · Devices · 2023-08-30
  Class II
• Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b

  Smith & Nephew, Inc. · Devices · 2023-05-02
  Class II
• DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coa

  Encore Medical, LP · Devices · 2023-08-04
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12M

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Vasc. Open CVOR SJH, REF SJVO56B

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al

  Abbott Laboratories · Devices · 2023-10-19
  Class II
• Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

  Wright Medical Technology, Inc. · Devices · 2023-04-10
  Class II
• Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-27
  Class II
• FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051

  Richard Wolf GmbH · Devices · 2023-03-24
  Class II
• COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

  Copan Diagnostics Inc · Devices · 2023-07-14
  Class II
• Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include:

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; an

  DeRoyal Industries Inc · Devices · 2023-04-17
  Class II
• Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US

  Covidien, LLC · Devices · 2023-06-02
  Class II
• Ringed DxI Reaction Vessels (RVs)

  Beckman Coulter, Inc. · Devices · 2023-06-20
  Class II
• Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

  Abiomed, Inc. · Devices · 2023-10-10
  Class II
• HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

  AMD Medicom Inc. · Devices · 2023-12-21
  Class II
• SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.

  SoClean, Inc · Devices · 2023-11-15
  Class II
• MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

  Cordis US Corp · Devices · 2023-11-28
  Class II
• Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.

  Aomori Olympus Co., Ltd. · Devices · 2023-07-27
  Class II
• LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

  Instrumentation Laboratory · Devices · 2023-09-29
  Class II
• ProxiDiagnost N90 R.1.0

  Philips North America · Devices · 2023-03-03
  Class II
• NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a p

  NeuroSync, Inc. · Devices · 2023-09-19
  Class II
• The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A

  Canon Medical System, USA, INC. · Devices · 2023-11-15
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Cata

  LumiraDx · Devices · 2023-04-25
  Class II
• Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)

  Atrium Medical Corporation · Devices · 2023-09-18
  Class II
• Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implan

  Exocad GmbH · Devices · 2023-08-17
  Class II
• RAPIDPOINT 500 Blood Gas System

  Siemens Healthcare Diagnostics Inc · Devices · 2023-09-26
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-L-100.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human s

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-09
  Class II
• The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Gr

  Bolton Medical Inc. · Devices · 2023-05-03
  Class II
• da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

  Intuitive Surgical, Inc. · Devices · 2023-02-10
  Class II
• AcuMatch Hip System, Catalog Number 142-32-27

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

  Unetixs Vascular, Inc. · Devices · 2023-02-10
  Class II
• Infinity FMS Pak

  Alcon Research, LTD. · Devices · 2023-06-28
  Class II
• Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to au

  Inpeco S.A. · Devices · 2023-11-03
  Class II
• FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352

  MICROVENTION INC. · Devices · 2023-06-07
  Class II
• REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

  Osteomed, LLC · Devices · 2023-05-31
  Class II
• LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of le

  Magellan Diagnostics, Inc. · Devices · 2023-09-19
  Class II
• NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

  Ansell Healthcare Products LLC · Devices · 2023-08-03
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651

  Cardinal Health 200, LLC · Devices · 2023-12-21
  Class II
• stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

  Tornier, Inc · Devices · 2023-09-15
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-04-17
  Class II
• DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractabl

  Stryker Medical Division of Stryker Corporation · Devices · 2023-05-24
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Mode

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan

  Philips North America Llc · Devices · 2023-08-31
  Class II
• Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

  Baxter Healthcare Corporation · Devices · 2023-05-19
  Class II
• DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num

  CooperSurgical, Inc. · Devices · 2023-02-13
  Class II
• Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an

  Nova Biomedical Corporation · Devices · 2023-09-18
  Class II
• Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

  Philips Ultrasound, Inc. · Devices · 2023-10-09
  Class II
• Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number

  Covidien, LP · Devices · 2023-03-01
  Class II
• RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

  Randox Laboratories Ltd. · Devices · 2023-09-06
  Class II
• Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

  Beckman Coulter, Inc. · Devices · 2023-04-05
  Class II
• Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removab

  Davol, Inc. · Devices · 2023-04-25
  Class II
• EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults a

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

  Avanos Medical, Inc. · Devices · 2023-04-24
  Class II
• Total Hip Kit, REF DYNJ903275S; surgical convenience kit

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-07-03
  Class II
• Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

  AtriCure, Inc. · Devices · 2023-11-28
  Class II
• TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

  Olympus Corporation of the Americas · Devices · 2023-09-28
  Class II
• Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 0

  Synovo Production · Devices · 2023-05-30
  Class II
• BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy

  Elekta Inc · Devices · 2023-02-28
  Class II
• Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

  Cardinal Health 200, LLC · Devices · 2023-09-13
  Class II
• LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

  Smiths Medical ASD Inc. · Devices · 2023-09-06
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015

  Stryker Corporation · Devices · 2023-09-11
  Class II
• EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M005

  Boston Scientific Corporation · Devices · 2023-09-27
  Class II
• Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Allura Xper series

  Philips Medical Systems Nederland B.V. · Devices · 2023-07-19
  Class II
• Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl

  Olympus Corporation of the Americas · Devices · 2023-05-26
  Class II
• THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including sing

  Olympus Corporation of the Americas · Devices · 2023-09-12
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

  Acclarent, Inc. · Devices · 2023-09-21
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

  Beckman Coulter Inc. · Devices · 2023-04-05
  Class II
• Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6

  Smiths Medical ASD Inc. · Devices · 2023-08-16
  Class II
• DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

  DeRoyal Industries Inc · Devices · 2023-11-22
  Class II
• Aptio Automation Storage and Retrieval Module (SRM)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-05-16
  Class II
• MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-08-03
  Class II
• Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-23
  Class II
• Lem Fertility hCG Pregnancy Urine Test REF 100-12

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS

  Medtronic Navigation, Inc. · Devices · 2023-11-28
  Class II
• Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-01

  Galt Medical Corporation · Devices · 2023-05-08
  Class II
• LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651

  Cardinal Health 200, LLC · Devices · 2023-12-21
  Class II
• Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endosc

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.

  Peter Lazic Gmbh · Devices · 2023-10-06
  Class II
• ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

  Siemens Medical Solutions USA, Inc. · Devices · 2023-07-13
  Class II
• Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06

  Smiths Medical ASD Inc. · Devices · 2023-08-16
  Class II
• DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• CombiDiagnost R90 R.1.0

  Philips North America · Devices · 2023-03-03
  Class II
• Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

  BioFire Diagnostics, LLC · Devices · 2023-05-08
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CARO

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W

  Maquet Cardiovascular, LLC · Devices · 2023-03-06
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

  Brainlab AG · Devices · 2023-02-14
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip art

  Howmedica Osteonics Corp. · Devices · 2023-12-22
  Class II
• Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti

  Philips North America · Devices · 2023-06-12
  Class II
• MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. elec

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-08-03
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor

  TELEFLEX LLC · Devices · 2023-05-25
  Class II
• MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429

  Cook Medical Llc · Devices · 2023-12-07
  Class II
• Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

  Baxter Healthcare Corporation · Devices · 2023-05-19
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• GEM FLOW COUPLER Monitor, PN 5156-00000-011

  Baxter Healthcare Corporation · Devices · 2023-06-19
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-12
  Class II
• Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIAL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including di

  Steris Corporation · Devices · 2023-03-17
  Class II
• HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

  Access Vascular, Inc · Devices · 2023-03-03
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Phoenix mKDR Xpress, digital mobile diagnostic x-ray system

  SEDECAL SA · Devices · 2023-02-06
  Class II
• Model No. BF-XP190, EVIS EXERA III Bronchovideoscope

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

  GE Healthcare · Devices · 2023-09-14
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

  Smiths Medical ASD Inc. · Devices · 2023-08-22
  Class II
• BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perf

  PTW-FREIBURG · Devices · 2023-06-07
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

  Vortex Surgical Inc. · Devices · 2023-12-18
  Class II
• Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that colle

  Moberg Research, Inc. · Devices · 2023-02-20
  Class II
• Injection Needle, LUER-lock,0.8mm, REF: 26175PD

  Karl Storz Endoscopy · Devices · 2023-10-24
  Class II
• HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

  Access Vascular, Inc · Devices · 2023-08-31
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Mode

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.

  Linet Spol. S.r.o. · Devices · 2023-01-18
  Class II
• Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

  Summit Medical, LLC · Devices · 2023-01-13
  Class II
• QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Bard¿ Lopez Valve¿ with ENFit, REF EN0056000

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• iQ Waste Well Adapter, Part Number: 700-3393

  Beckman Coulter, Inc. · Devices · 2023-12-19
  Class II
• EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

  Physio-Control, Inc. · Devices · 2023-11-06
  Class II
• Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Intelli-C, Right side suspended Tabletop, REF: 03400000

  NRT X-RAY A/S · Devices · 2023-04-27
  Class II
• LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au

  DKK Dai-Ichi Shomei Co., Ltd. · Devices · 2023-08-23
  Class II
• SOZO Bilateral Arm L-Dex Software

  Impedimed Limited · Devices · 2023-08-17
  Class II
• Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive

  ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Devices · 2023-08-29
  Class II
• CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimete

  Landauer · Devices · 2023-07-12
  Class II
• Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include:

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy f

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6

  Medtronic Inc · Devices · 2023-10-12
  Class II
• IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B2018176

  Medicrea International · Devices · 2023-07-12
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Terragene Bionova PCD (PCD222-C)

  TERRAGENE S.A. · Devices · 2023-12-07
  Class II
• Detector H. Pylori, Catalog Number IHP-30

  Immunostics, Inc. · Devices · 2023-08-25
  Class II
• Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

  Fenwal Inc · Devices · 2023-02-14
  Class II
• BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatmen

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• CD11b APC: ASR, REF: 340936, and CE, REF: 333143

  Becton, Dickinson and Company, BD Biosciences · Devices · 2023-10-25
  Class II
• Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

  Philips North America · Devices · 2023-04-25
  Class II
• Aeris Balloon Dilation Catheter

  Bryan Medical Inc · Devices · 2023-05-16
  Class II
• PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

  Edwards Lifesciences, LLC · Devices · 2023-07-27
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number D

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

  Covidien · Devices · 2023-08-10
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

  Encore Medical, LP · Devices · 2023-09-25
  Class II
• BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to th

  RONAN MEDICAL LLC · Devices · 2023-12-11
  Class II
• DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-03-28
  Class II
• Trexo Device

  Trexo Robotics Holdings Inc. · Devices · 2023-05-31
  Class II
• Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Dig

  Western/Scott Fetzer Company · Devices · 2023-01-03
  Class II
• ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.

  Siemens Medical Solutions USA, Inc · Devices · 2023-06-19
  Class II
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used Wit

  Remote Diagnostic Technologies Ltd. · Devices · 2023-08-24
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexib

  Olympus Corporation of the Americas · Devices · 2023-05-26
  Class II
• Exactech Ergo Impactor Handle, Catalog #321-09-05.

  Exactech, Inc. · Devices · 2023-06-05
  Class II
• Medtronic InterStim Ground Pad REF 041826

  Medtronic Neuromodulation · Devices · 2023-07-06
  Class II
• QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende

  Qiagen GmbH · Devices · 2023-05-19
  Class II
• QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, RE

  DeRoyal Industries Inc · Devices · 2023-05-30
  Class II
• VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

  Greiner Bio-One North America, Inc. · Devices · 2023-12-12
  Class II
• Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the Ex

  Globus Medical, Inc. · Devices · 2023-12-11
  Class II
• Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

  Windstone Medical Packaging, Inc. · Devices · 2023-04-24
  Class II
• DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• OMTMO One Step Ovulation (LH) Test Strips REF 200-07

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tr

  TELEFLEX LLC · Devices · 2023-04-12
  Class II
• BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen

  T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Devices · 2023-05-04
  Class II
• Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizat

  Ambu Inc. · Devices · 2023-07-21
  Class II
• ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-01
  Class II
• Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

  CardioQuip, LLC · Devices · 2023-10-19
  Class II
• Express Mini 500 Dry Seal Chest Drain, Part Number 16400

  Atrium Medical Corporation · Devices · 2023-03-01
  Class II
• Insufflation unit, UHI-4.

  Olympus Corporation of the Americas · Devices · 2023-09-25
  Class II
• Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

  Biosense Webster, Inc. · Devices · 2023-02-21
  Class II
• Visera Hysterovideoscope Olympus HYF Type V

  Olympus Corporation of the Americas · Devices · 2023-07-20
  Class II
• Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871

  Philips North America · Devices · 2023-12-07
  Class II
• MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK

  CareFusion 303, Inc. · Devices · 2023-10-05
  Class II
• ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and c

  Maquet Cardiovascular, LLC · Devices · 2023-06-28
  Class II
• TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization

  Synthes (USA) Products LLC · Devices · 2023-02-01
  Class II
• Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

  Stryker Corporation · Devices · 2023-08-23
  Class II
• Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

  Scientia Vascular, Inc. · Devices · 2023-02-01
  Class II
• Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

  Medtronic Neuromodulation · Devices · 2023-06-06
  Class II
• Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Flow-i C20 Anesthesia System, model 6677200

  Getinge Usa Sales Inc · Devices · 2023-12-11
  Class II
• Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen

  Meridian Bioscience Inc · Devices · 2023-10-19
  Class II
• Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, a

  Stryker Corporation · Devices · 2023-09-13
  Class II
• Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

  Encore Medical, LP · Devices · 2023-10-05
  Class II
• Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest

  Maquet Cardiovascular, LLC · Devices · 2023-06-28
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ8

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

  FX SHOULDER · Devices · 2023-08-08
  Class II
• One Step Pregnancy Test REF 100-01

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and ch

  Maquet Cardiovascular, LLC · Devices · 2023-06-28
  Class II
• ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li

  Elekta, Inc. · Devices · 2023-10-25
  Class II
• ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-08-08
  Class II
• Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

  Baxter Healthcare Corporation · Devices · 2023-11-15
  Class II
• PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

  Limacorporate S.p.A · Devices · 2023-10-27
  Class II
• (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC

  Philips North America · Devices · 2023-11-28
  Class II
• Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-04-05
  Class II
• Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN

  TruAbutment Inc. · Devices · 2023-12-27
  Class II
• Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

  Philips North America Llc · Devices · 2023-03-09
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K rewo

  Convergent Dental · Devices · 2023-09-01
  Class II
• VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS

  Covidien LP · Devices · 2023-03-22
  Class II
• Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-26
  Class II
• CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary art

  St. Jude Medical · Devices · 2023-02-07
  Class II
• nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT;

  Landauer · Devices · 2023-07-12
  Class II
• HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

  Philips North America Llc · Devices · 2023-09-21
  Class II
• Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

  TELEFLEX LLC · Devices · 2023-05-25
  Class II
• QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR reade

  Landauer · Devices · 2023-07-12
  Class II
• Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surg

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

  Randox Laboratories Ltd. · Devices · 2023-11-20
  Class II
• SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

  PATH · Devices · 2023-09-26
  Class II
• Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

  Covidien, LP · Devices · 2023-01-25
  Class II
• CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary

  St. Jude Medical · Devices · 2023-02-07
  Class II
• Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stoo

  IMMUNDIAGNOSTIK, Inc · Devices · 2023-03-27
  Class II
• Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135

  Stryker Corporation · Devices · 2023-03-01
  Class II
• OEC Flexiview 8800 Systems with 9-inch Image Intensifier

  GE OEC Medical Systems, Inc · Devices · 2023-05-15
  Class II
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099

  Datascope Corp. · Devices · 2023-02-28
  Class II
• Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive

  Siemens Medical Solutions USA, Inc · Devices · 2023-06-05
  Class II
• Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0

  Smiths Medical ASD Inc. · Devices · 2023-08-16
  Class II
• MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"

  Aesculap Inc · Devices · 2023-12-29
  Class II
• Welch Allyn Connex Spot Monitor

  Baxter Healthcare Corporation · Devices · 2023-08-10
  Class II
• TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

  Beckman Coulter Inc. · Devices · 2023-04-05
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

  Medacta Usa Inc · Devices · 2023-03-08
  Class II
• Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w

  Globus Medical, Inc. · Devices · 2023-12-11
  Class II
• Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

  Philips North America Llc · Devices · 2023-03-09
  Class II
• PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Medicine Dropper, Product Code K508

  Apothecary Products, LLC · Devices · 2023-03-30
  Class II
• Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Ant

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31

  Roche Diagnostics Operations, Inc. · Devices · 2023-10-03
  Class II
• Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

  LEICA BIOSYSTEMS NUSSLOCH GMBH · Devices · 2023-11-20
  Class II
• RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

  Randox Laboratories Ltd. · Devices · 2023-09-06
  Class II
• DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defect

  Musculoskeletal Transplant Foundation, Inc. · Devices · 2023-09-22
  Class II
• SmartPath to dStream for 1.5T

  Philips North America Llc · Devices · 2023-10-23
  Class II
• HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

  Access Vascular, Inc · Devices · 2023-08-31
  Class II
• DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

  AURIS HEALTH INC · Devices · 2023-10-18
  Class II
• BrightView, Gamma Camera System, Product Code 882480.

  Philips North America · Devices · 2023-11-30
  Class II
• Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percut

  ARROW INTERNATIONAL Inc. · Devices · 2023-08-10
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN H

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully au

  Hologic, Inc. · Devices · 2023-12-15
  Class II
• Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZ

  Smith & Nephew, Inc. · Devices · 2023-05-02
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DY

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiogr

  Carestream Health, Inc. · Devices · 2023-01-30
  Class II
• Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE

  Merit Medical Systems, Inc. · Devices · 2023-11-06
  Class II
• KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

  Karl Storz Endoscopy · Devices · 2023-04-05
  Class II
• DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2023-04-13
  Class II
• Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

  J&T Health and Wellness LLC · Devices · 2023-03-31
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical devic

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human se

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-07-10
  Class II
• AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

  Tornier, Inc · Devices · 2023-06-12
  Class II
• Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI

  Shanghai United Imaging Healthcare Co., Ltd. · Devices · 2023-03-01
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• CVS PCSU SJH, REF SJCV48J

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

  Intuitive Surgical, Inc. · Devices · 2023-06-12
  Class II
• Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Medtronic SynchroMed II, Model 8637-40, Programmable pump

  Medtronic Neuromodulation · Devices · 2023-11-13
  Class II
• EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in a

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

  TECHNO-PATH MANUFACTURING LTD. · Devices · 2023-08-25
  Class II
• F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

  GE Medical Systems China Co., Ltd. · Devices · 2023-09-08
  Class II
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

  Bio-Rad Laboratories, Inc. · Devices · 2023-02-28
  Class II
• Pediatric Heart SJH, REF SJPH34K

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended fo

  Covidien, LP · Devices · 2023-01-11
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-56

  Olympus Corporation of the Americas · Devices · 2023-08-10
  Class II
• TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA

  Full Vision Inc · Devices · 2023-05-12
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART L

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

  DePuy Orthopaedics, Inc. · Devices · 2023-02-15
  Class II
• Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers

  Landauer · Devices · 2023-07-12
  Class II
• Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

  Unetixs Vascular, Inc. · Devices · 2023-02-10
  Class II
• MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

  Philips North America · Devices · 2023-06-12
  Class II
• Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monit

  Inmar Supply Chain Solutions, LLC · Devices · 2023-08-24
  Class II
• Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-

  DeRoyal Industries Inc · Devices · 2023-05-30
  Class II
• Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Bubble Sensor (REF: 70105.5720)

  Maquet Medical Systems USA · Devices · 2023-12-28
  Class II
• Flow-e Anesthesia System, model 6887900

  Getinge Usa Sales Inc · Devices · 2023-12-11
  Class II
• OPMI LUMERA 300, REF 6137

  Carl Zeiss Suzhou Co., Ltd. · Devices · 2023-08-18
  Class II
• PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PD

  ETHICON, LLC · Devices · 2023-08-10
  Class II
• PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, di

  Stryker Corporation · Devices · 2023-07-10
  Class II
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Allen Advance Chest Support with Pad

  Baxter Healthcare Corporation · Devices · 2023-05-18
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed f

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adult

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102

  Blue Belt Technologies, Inc · Devices · 2023-09-07
  Class II
• THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

  PATH · Devices · 2023-09-26
  Class II
• CombiDiagnost R90 R1.1

  Philips North America · Devices · 2023-03-03
  Class II
• MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

  Murata Vios, Inc. · Devices · 2023-06-06
  Class II
• Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Fisher Wallace Stimulator Models FW-100 and FW-200

  Fisher Wallace Laboratories Inc. · Devices · 2023-04-06
  Class II
• Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929

  Full Vision Inc · Devices · 2023-05-12
  Class II
• DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

  Beckman Coulter, Inc. · Devices · 2023-09-12
  Class II
• Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electri

  Oakworks Inc · Devices · 2023-12-05
  Class II
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model N

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

  Aizu Olympus Co., Ltd. · Devices · 2023-10-16
  Class II
• B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dos

  B. Braun Medical, Inc. · Devices · 2023-08-07
  Class II
• PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• VITROS XT Chemistry Products TBIL-ALKP Slides

  Ortho-Clinical Diagnostics, INc. · Devices · 2023-08-05
  Class II
• BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• Olympus Bronchovideoscope, Model BF-Q180-AC

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814

  C.R. Bard Inc · Devices · 2023-04-20
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

  Covidien LP · Devices · 2023-08-22
  Class II
• Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA -

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accel

  Inpeco S.A. · Devices · 2023-03-10
  Class II
• Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

  DiaSorin Molecular LLC · Devices · 2023-01-30
  Class II
• Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

  PHILIPS HEADQUARTERS CAMBRIDGE · Devices · 2023-04-12
  Class II
• Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti

  Philips North America · Devices · 2023-06-12
  Class II
• Medline Leg bag, REF DYND12578

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-10-19
  Class II
• Alcon Custom Pak

  Alcon Research, LTD. · Devices · 2023-06-28
  Class II
• MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclina

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-14
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Mod

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number

  Abbott Laboratories · Devices · 2023-10-19
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Prote

  Aniara Diagnostica LLC · Devices · 2023-02-01
  Class II
• TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

  Howmedica Osteonics Corp. · Devices · 2023-04-13
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE

  Aizu Olympus Co., Ltd. · Devices · 2023-10-16
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical devic

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 2

  Baxter Healthcare Corporation · Devices · 2023-03-31
  Class II
• Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation mon

  Landauer · Devices · 2023-07-12
  Class II
• BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW AB

  Becton Dickinson & Company · Devices · 2023-10-11
  Class II
• Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTA

  Landauer · Devices · 2023-07-12
  Class II
• MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Cat

  Quidel Corporation · Devices · 2023-02-01
  Class II
• DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images

  Philips North America Llc · Devices · 2023-09-21
  Class II
• Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm

  Securitas Healthcare LLC · Devices · 2023-09-25
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte

  Ethicon Endo-Surgery Inc · Devices · 2023-12-11
  Class II
• Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows

  Stryker Corporation · Devices · 2023-08-07
  Class II
• UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cyst

  Scholly Fiberoptic Gmbh · Devices · 2023-06-23
  Class II
• SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c

  Coltene Whaledent Inc · Devices · 2023-01-20
  Class II
• Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

  NeuroLogica Corporation · Devices · 2023-12-28
  Class II
• EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

  Phadia Ab · Devices · 2023-05-24
  Class II
• VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-10-10
  Class II
• PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-01
  Class II
• RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6

  Smiths Medical ASD Inc. · Devices · 2023-08-16
  Class II
• SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intende

  Wilson-Cook Medical Inc. · Devices · 2023-06-22
  Class II
• DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postop

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2023-04-13
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through

  Maquet Medical Systems USA · Devices · 2023-11-06
  Class II
• EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

  Natus Medical Incorporated · Devices · 2023-11-28
  Class II
• Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-V

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

  MICROVENTION INC. · Devices · 2023-08-24
  Class II
• LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

  Boston Scientific Corporation · Devices · 2023-02-02
  Class II
• BLOOD CULTURE KIT, REF DYNDH1647B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-01
  Class II
• M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number

  Zimmer, Inc. · Devices · 2023-07-26
  Class II
• JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

  Smith & Nephew, Inc. · Devices · 2023-09-27
  Class II
• Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers RO

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock

  Ossur H / F · Devices · 2023-05-12
  Class II
• CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmo

  St. Jude Medical · Devices · 2023-10-04
  Class II
• NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

  Illumina, Inc. · Devices · 2023-04-05
  Class II
• ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000

  Abbott Laboratories · Devices · 2023-10-19
  Class II
• nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosi

  Landauer · Devices · 2023-07-12
  Class II
• Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu

  Olympus Corporation of the Americas · Devices · 2023-05-04
  Class II
• Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

  BioFire Diagnostics, LLC · Devices · 2023-03-08
  Class II
• Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Numb

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTA

  Landauer · Devices · 2023-07-12
  Class II
• Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• BD Synapsys Informatics Solution, Catalog Number 444150

  Becton Dickinson & Co. · Devices · 2023-06-08
  Class II
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c)

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code

  O&M HALYARD, INC. · Devices · 2023-08-09
  Class II
• KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightgua

  Keystone Industries · Devices · 2023-11-20
  Class II
• IRON assay, Reference Numbers 6K95-41 and 6K95-30

  Sentinel CH SpA · Devices · 2023-09-29
  Class II
• Olympus Bronchovideoscope, Models BF-MP190F.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• BD Pyxis MedStation 4000 Main, REF 303

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devic

  Medicrea International · Devices · 2023-07-12
  Class II
• Ingenia 1.5T CX

  Philips North America Llc · Devices · 2023-10-23
  Class II
• VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Dat

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-04-14
  Class II
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• STERILE PVP, REF DYNDA1649

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0

  Smiths Medical ASD Inc. · Devices · 2023-12-19
  Class II
• Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port,

  Stryker Sustainability Solutions · Devices · 2023-03-01
  Class II
• Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunc

  Stryker Corporation · Devices · 2023-01-25
  Class II
• Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND L

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-03-09
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical devic

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014

  DeRoyal Industries Inc · Devices · 2023-05-30
  Class II
• Cath Cardiac Pack, REF IHCC03V

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimete

  Landauer · Devices · 2023-07-12
  Class II
• Functional MR V1.0

  OLEA MEDICAL · Devices · 2023-08-10
  Class II
• DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

  TELEFLEX LLC · Devices · 2023-05-25
  Class II
• The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total P

  BioReference Health, LLC · Devices · 2023-10-31
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CON

  Carefusion 2200 Inc · Devices · 2023-01-30
  Class II
• Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Lef

  Acumed LLC · Devices · 2023-12-19
  Class II
• Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI

  Atrium Medical Corporation · Devices · 2023-09-18
  Class II
• Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• STERILE STERILE PREP STICK, REF DYNDA1134

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• Calibration Serum Level 3 CAL2351

  Randox Laboratories Ltd. · Devices · 2023-11-20
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)

  Musculoskeletal Transplant Foundation, Inc. · Devices · 2023-12-22
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 2

  Advance Medical Designs, Inc. · Devices · 2023-07-07
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

  Cardinal Health 200, LLC · Devices · 2023-04-06
  Class II
• Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BAN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air remova

  3M Company - Health Care Business · Devices · 2023-08-22
  Class II
• BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

  Bio-Rad Laboratories, Inc. · Devices · 2023-02-21
  Class II
• FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

  G & H Wire Company · Devices · 2023-12-21
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amal

  Keystone Industries · Devices · 2023-07-21
  Class II
• ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation

  LEONI CIA CABLE SYSTEMS · Devices · 2023-10-06
  Class II
• Achieva 1.5T

  Philips North America Llc · Devices · 2023-10-23
  Class II
• Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The

  Angel Medical Systems, Inc. · Devices · 2023-09-01
  Class II
• BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A131

  Medicrea International · Devices · 2023-07-12
  Class II
• ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-03-16
  Class II
• Barco MDSC-8527 NXF, Part Number K9352421

  Barco N.V. · Devices · 2023-12-20
  Class II
• Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)

  PHILIPS HEADQUARTERS CAMBRIDGE · Devices · 2023-04-12
  Class II
• DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

  DeRoyal Industries Inc · Devices · 2023-02-09
  Class II
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x1

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N

  GE OEC Medical Systems, Inc · Devices · 2023-05-15
  Class II
• CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

  Terumo Cardiovascular Systems Corporation · Devices · 2023-03-01
  Class II
• Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to

  Siemens Healthcare Diagnostics Inc · Devices · 2023-10-26
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-29
  Class II
• NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, re

  Mc3 Inc · Devices · 2023-10-11
  Class II
• SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in th

  Datascope Corp. · Devices · 2023-06-23
  Class II
• TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

  Smith & Nephew, Inc. · Devices · 2023-07-24
  Class II
• BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

  Philips North America · Devices · 2023-10-09
  Class II
• Azurion

  Philips Medical Systems Nederland B.V. · Devices · 2023-07-19
  Class II
• TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

  Datascope Corp. · Devices · 2023-06-23
  Class II
• WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Broc

  WAVi Co. · Devices · 2023-12-08
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, frac

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

  BioFire Diagnostics, LLC · Devices · 2023-02-01
  Class II
• CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary

  St. Jude Medical · Devices · 2023-02-07
  Class II
• 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam

  3M Company - Health Care Business · Devices · 2023-08-22
  Class II
• P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product

  Megadyne Medical Products, Inc. · Devices · 2023-06-15
  Class II
• Model No. CYF-5R, Cystonephrofiberscope

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, T

  Alphatec Spine, Inc. · Devices · 2023-07-07
  Class II
• DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate posto

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2023-04-13
  Class II
• MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device

  Medacta Usa Inc · Devices · 2023-03-08
  Class II
• Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

  Fenwal Inc · Devices · 2023-02-14
  Class II
• Oculus Myopia Master , Ref 68100, CE 0123

  Oculus Optikgeraete GMBH · Devices · 2023-08-08
  Class II
• LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT M

  Smith & Nephew, Inc. · Devices · 2023-05-02
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosi

  Landauer · Devices · 2023-07-12
  Class II
• Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C,

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Contour¿ next GEN Blood Glucose Monitoring System

  Ascensia Diabetes Care US, Inc. · Devices · 2023-05-19
  Class II
• Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the us

  Stryker Corporation · Devices · 2023-08-07
  Class II
• BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

  CareFusion 303, Inc. · Devices · 2023-04-05
  Class II
• ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and

  Cytrellis Biosystems, Inc. · Devices · 2023-06-23
  Class II
• BrightView XCT, Gamma Camera, Product Code 882482

  Philips North America · Devices · 2023-11-30
  Class II
• Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-06-30
  Class II
• DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO

  Encore Medical, LP · Devices · 2023-11-10
  Class II
• Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813

  Philips North America · Devices · 2023-03-20
  Class II
• A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

  Medtronic Neuromodulation · Devices · 2023-06-21
  Class II
• CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

  Terumo Cardiovascular Systems Corporation · Devices · 2023-03-01
  Class II
• TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926

  Full Vision Inc · Devices · 2023-05-12
  Class II
• VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

  Luminex Corporation · Devices · 2023-06-05
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices

  Globus Medical, Inc. · Devices · 2023-12-11
  Class II
• Exactech Novation Hip System, Catalog Numbers: 134-36-45

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) S

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B201719

  Medicrea International · Devices · 2023-07-12
  Class II
• D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

  Peter Lazic Gmbh · Devices · 2023-10-06
  Class II
• Fargo Ortho-K Lens

  PARAGON VISION SCIENCES, Inc · Devices · 2023-06-26
  Class II
• External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

  Natus Medical Incorporated · Devices · 2023-11-28
  Class II
• Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Robotics Pack, REF SSRO22D

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• DiagnosUS One Step LH Ovulation Test Strip REF 200-07

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous jo

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Po

  Smiths Medical ASD Inc. · Devices · 2023-04-05
  Class II
• Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix b

  Stryker Corporation · Devices · 2023-08-07
  Class II
• Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD5675

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accele

  Inpeco S.A. · Devices · 2023-03-10
  Class II
• ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

  Zeus Scientific, Inc. · Devices · 2023-10-31
  Class II
• Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

  Merit Medical Systems, Inc. · Devices · 2023-02-15
  Class II
• Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to m

  Stryker Corporation · Devices · 2023-08-07
  Class II
• MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S450

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm

  IHB OPERATIONS B.V. · Devices · 2023-07-19
  Class II
• ambIT Cassette Filter Male Luer, Product Code: 220266

  Avanos Medical, Inc. · Devices · 2023-04-24
  Class II
• Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

  Ambu Inc. · Devices · 2023-12-05
  Class II
• Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog

  Olympus Corporation of the Americas · Devices · 2023-05-04
  Class II
• Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Vers

  Turncare, Inc · Devices · 2023-11-01
  Class II
• AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material t

  Covidien LP · Devices · 2023-11-16
  Class II
• ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac

  Elekta, Inc. · Devices · 2023-10-25
  Class II
• Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

  Medtronic Sofamor Danek USA Inc · Devices · 2023-07-31
  Class II
• NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Co

  THOR Photomedicine Ltd · Devices · 2023-11-20
  Class II
• EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359

  Philips North America Llc · Devices · 2023-03-06
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

  Tornier, Inc · Devices · 2023-06-12
  Class II
• Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

  Aesculap Inc · Devices · 2023-12-29
  Class II
• Allura Xper FD10 and FD20. X-ray Imaging System.

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-06-12
  Class II
• HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A0000

  Baxter Healthcare Corporation · Devices · 2023-10-04
  Class II
• Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J;

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human seru

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-07-10
  Class II
• Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20C

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Puritan Bennett Cuff Pressure Manager, REF: 180-03

  Covidien · Devices · 2023-08-22
  Class II
• The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator

  GE Hangwei Medical Systems, Co. LTD · Devices · 2023-11-07
  Class II
• Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Applic

  Boston Scientific Corporation · Devices · 2023-11-30
  Class II
• Flow-i C30 Anesthesia System, model 6677300

  Getinge Usa Sales Inc · Devices · 2023-12-11
  Class II
• SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

  DeVilbiss Healthcare LLC · Devices · 2023-03-09
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack A

  ASO LLC · Devices · 2023-03-23
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6"

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25

  Labories Medical Technologies · Devices · 2023-02-07
  Class II
• therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection o

  Qiagen GmbH · Devices · 2023-08-22
  Class II
• BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bond

  Becton Dickinson & Company · Devices · 2023-10-11
  Class II
• PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive erro

  Reichert, Inc. · Devices · 2023-07-20
  Class II
• stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

  Wright Medical Technology, Inc. · Devices · 2023-04-10
  Class II
• ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Ma

  Siemens Medical Solutions USA, Inc · Devices · 2023-03-21
  Class II
• These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, viruc

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-20
  Class II
• EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

  Philips North America Llc · Devices · 2023-03-06
  Class II
• Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleare

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-H

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver

  Argon Medical Devices, Inc · Devices · 2023-06-08
  Class II
• Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

  Paragon 28, Inc. · Devices · 2023-12-21
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an

  Maquet Medical Systems USA · Devices · 2023-11-13
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S4310

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w

  RAYSEARCH LABORATORIES AB · Devices · 2023-09-12
  Class II
• Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• GE Healthcare Vivid S70N, ultrasound device

  GE Vingmed Ultrasound As · Devices · 2023-05-30
  Class II
• FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

  BioFire Diagnostics, LLC · Devices · 2023-05-08
  Class II
• Article No. NA6050411, Valiant PhD No. 1 Econo

  Ivoclar Vivadent, Inc. · Devices · 2023-12-21
  Class II
• Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

  Omega Medical Imaging, Inc. · Devices · 2023-09-08
  Class II
• SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R

  Siemens Medical Solutions USA, Inc. · Devices · 2023-01-16
  Class II
• Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.

  SEDECAL SA · Devices · 2023-12-13
  Class II
• BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

  Becton Dickinson Infusion Therapy Systems Inc. · Devices · 2023-10-04
  Class II
• DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

  CooperVision, Inc. · Devices · 2023-02-14
  Class II
• REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach

  Compass Health Brands (Corporate Office) · Devices · 2023-03-07
  Class II
• Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Number

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• MED-810A Zemits NDPrime Laser products

  Advance-Esthetic LLC · Devices · 2023-10-09
  Class II
• HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic

  Siemens Medical Solutions USA, Inc · Devices · 2023-09-01
  Class II
• PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum a

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-27
  Class II
• SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments

  Biomerieux Inc · Devices · 2023-02-06
  Class II
• Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for per

  Baxter Healthcare Corporation · Devices · 2023-02-01
  Class II
• ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment

  Advanced Research Medical, LLC · Devices · 2023-03-14
  Class II
• Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and

  Zyno Medical LLC · Devices · 2023-12-20
  Class II
• HealthyWiser UriTest" UTI Test Strips REF 900-UTI

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional

  Canon Medical System, USA, INC. · Devices · 2023-11-15
  Class II
• MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

  Philips North America · Devices · 2023-06-12
  Class II
• BD Pyxis Med 4000 Auxiliary (AUX), REF 314

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 serie

  DKK Dai-Ichi Shomei Co., Ltd. · Devices · 2023-08-23
  Class II
• BD Pyxis MedStation ES (Med ES Main), REF 323

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)

  CooperVision, Inc. · Devices · 2023-01-26
  Class II
• NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c

  Medtronic Xomed, Inc. · Devices · 2023-11-07
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABS

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, lig

  Olympus Corporation of the Americas · Devices · 2023-11-20
  Class II
• DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2023-04-13
  Class II
• (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Caref

  Carefusion 2200 Inc · Devices · 2023-03-16
  Class II
• FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

  Richard Wolf GmbH · Devices · 2023-03-24
  Class II
• FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

  Abbott Diabetes Care, Inc. · Devices · 2023-07-12
  Class II
• DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR re

  Landauer · Devices · 2023-07-12
  Class II
• Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histolog

  Technidata S.A. · Devices · 2023-03-27
  Class II
• Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

  Beckman Coulter Biomedical GmbH · Devices · 2023-06-02
  Class II
• Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and Co

  GE Medical Systems Information Technologies Inc · Devices · 2023-08-08
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring do

  Landauer · Devices · 2023-07-12
  Class II
• Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX),

  Inpeco S.A. · Devices · 2023-03-10
  Class II
• smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee j

  Smith & Nephew Inc · Devices · 2023-08-31
  Class II
• Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Model No. BF-P190, EVIS EXERA III Bronchovideoscope

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary

  St. Jude Medical · Devices · 2023-02-07
  Class II
• Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

  DeRoyal Industries Inc · Devices · 2023-05-30
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

  Siemens Medical Solutions USA, Inc. · Devices · 2023-01-16
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical d

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive

  ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Devices · 2023-08-29
  Class II
• LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 bo

  DiaSorin Molecular LLC · Devices · 2023-06-14
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Sub Q Recorder Pack, REF BPRC87A

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.

  DeRoyal Industries Inc · Devices · 2023-04-17
  Class II
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• BD Recanalization System, REF: BDRECANSYSTEM

  Bard Peripheral Vascular Inc · Devices · 2023-11-14
  Class II
• Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and du

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] T

  TERRAGENE S.A. · Devices · 2023-12-07
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

  Securitas Healthcare LLC · Devices · 2023-09-25
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMI

  Covidien, LP · Devices · 2023-03-01
  Class II
• Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect De

  Boston Scientific Neuromodulation Corporation · Devices · 2023-05-12
  Class II
• Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d)

  Advance Medical Designs, Inc. · Devices · 2023-07-07
  Class II
• RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosi

  Landauer · Devices · 2023-07-12
  Class II
• LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW

  Implant Direct Sybron Manufacturing LLC · Devices · 2023-05-02
  Class II
• Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 29892

  OmniCell, Inc. · Devices · 2023-03-27
  Class II
• Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and en

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Phaco Standalone Tips

  Alcon Research, LTD. · Devices · 2023-06-28
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• UroPass Ureteral Access Sheaths, 5 pieces/box

  Olympus Corporation of the Americas · Devices · 2023-05-19
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTR

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

  Datascope Corp. · Devices · 2023-06-23
  Class II
• Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry S

  Keystone Industries · Devices · 2023-04-10
  Class II
• 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM G

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

  Beckman Coulter, Inc. · Devices · 2023-11-21
  Class II
• Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Achieva 1.5T Initial System

  Philips North America Llc · Devices · 2023-10-23
  Class II
• 3T Heater Cooler System, REF: 16-02-85

  LivaNova Deutschland GmbH · Devices · 2023-08-03
  Class II
• RAPIDPOINT 500e Blood Gas System

  Siemens Healthcare Diagnostics Inc · Devices · 2023-09-26
  Class II
• Access Thyroglobulin Calibrators

  Beckman Coulter, Inc. · Devices · 2023-07-06
  Class II
• TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

  Johnson & Johnson Surgical Vision, Inc. · Devices · 2023-07-06
  Class II
• The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ

  LeMaitre Vascular, Inc. · Devices · 2023-07-13
  Class II
• Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary

  Flower Orthopedics Corporation · Devices · 2023-08-29
  Class II
• GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L

  Paragon 28, Inc. · Devices · 2023-12-21
  Class II
• REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

  Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. · Devices · 2023-06-09
  Class II
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099

  Datascope Corp. · Devices · 2023-02-07
  Class II
• Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)

  FUJIFILM Healthcare Americas Corporation · Devices · 2023-11-23
  Class II
• Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

  Steris Corporation · Devices · 2023-12-12
  Class II
• ESG PK CUTTING FORCEPS, 5MM, 33CM

  Olympus Corporation of the Americas · Devices · 2023-12-15
  Class II
• Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimete

  Landauer · Devices · 2023-07-12
  Class II
• PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• FoundationOne Companion Diagnostic (F1CDx)

  Foundation Medicine, Inc. · Devices · 2023-02-15
  Class II
• Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2)

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• DigitalDiagnost C90, Model No. 712034 and 712035

  Philips North America Llc · Devices · 2023-05-19
  Class II
• Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

  Boston Scientific Corporation · Devices · 2023-07-11
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical int

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

  Beckman Coulter Biomedical GmbH · Devices · 2023-06-02
  Class II
• SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinol

  Instrumentation Laboratory · Devices · 2023-02-03
  Class II
• nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR re

  Landauer · Devices · 2023-07-12
  Class II
• Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit num

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G;

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

  Aizu Olympus Co., Ltd. · Devices · 2023-10-16
  Class II
• ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), ac

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-04-05
  Class II
• COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

  Merit Medical Systems, Inc. · Devices · 2023-03-21
  Class II
• Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use dur

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• VADER pedicle system, torque wrench, Catalog Number 42-703

  Icotec Ag · Devices · 2023-11-28
  Class II
• Model No. CYF-5, Cystonephrofiberscope

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophag

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2

  Philips Ultrasound, Inc. · Devices · 2023-06-30
  Class II
• Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

  DeRoyal Industries Inc · Devices · 2023-09-18
  Class II
• Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbishe

  Beckman Coulter, Inc. · Devices · 2023-01-26
  Class II
• Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that requi

  TELEFLEX LLC · Devices · 2023-04-28
  Class II
• MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical inst

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-08-03
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-LE-450.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 c

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

  Masimo Corporation · Devices · 2023-04-21
  Class II
• Mobilett Mira wireless (VA20) mobile x-ray system(s)

  Siemens Medical Solutions USA, Inc · Devices · 2023-10-05
  Class II
• Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of

  Atrium Medical Corporation · Devices · 2023-09-21
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J;

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

  Thoratec Corp. · Devices · 2023-08-07
  Class II
• SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

  Olympus Corporation of the Americas · Devices · 2023-12-04
  Class II
• JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

  Smith & Nephew, Inc. · Devices · 2023-09-27
  Class II
• Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

  PHILIPS HEADQUARTERS CAMBRIDGE · Devices · 2023-04-12
  Class II
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

  Datascope Corp. · Devices · 2023-07-31
  Class II
• EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Zenition 50 & 70 Mobile Surgery C-arm

  Philips North America · Devices · 2023-10-04
  Class II
• Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• API3200MD Mass Spectrometer, Part Number 4466230

  AB Sciex, LLC · Devices · 2023-08-30
  Class II
• MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• BD Pyxis MedStation 4000 AUX, REF 306

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• DiagnosUS Ovulation Predictor Midstream REF 200-17

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

  Covidien · Devices · 2023-08-10
  Class II
• IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B1612451

  Medicrea International · Devices · 2023-07-12
  Class II
• Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition

  DiaSorin Molecular LLC · Devices · 2023-01-30
  Class II
• Achieva 1.5T Conversion

  Philips North America Llc · Devices · 2023-10-23
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter R

  Bard Peripheral Vascular Inc · Devices · 2023-01-04
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: C

  Olympus Corporation of the Americas · Devices · 2023-04-18
  Class II
• CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C

  Townsend Design · Devices · 2023-09-23
  Class II
• Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str

  Visgeneer, Inc. · Devices · 2023-10-04
  Class II
• Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or prev

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

  Randox Laboratories Ltd. · Devices · 2023-09-06
  Class II
• REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

  Encore Medical, LP · Devices · 2023-10-05
  Class II
• DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

  Diasorin Inc. · Devices · 2023-12-13
  Class II
• RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating

  Cytocell Ltd. · Devices · 2023-05-24
  Class II
• MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

  Medacta Usa Inc · Devices · 2023-03-08
  Class II
• Breast Plastics Pack, REF BBPL20D

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• MINISCAV (tm) Vacuum Pump

  R A Medical Services · Devices · 2023-08-23
  Class II
• DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation

  LEONI CIA CABLE SYSTEMS · Devices · 2023-10-06
  Class II
• (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436

  Philips North America · Devices · 2023-11-28
  Class II
• VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to

  Olympus Corporation of the Americas · Devices · 2023-05-26
  Class II
• Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-1090

  DeRoyal Industries Inc · Devices · 2023-05-30
  Class II
• AT HOME MARIJUANA TEST STRIP, SKU 900752

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood,

  Mc3 Inc · Devices · 2023-10-11
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYN

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Fusion Bioline Vascular Graft, Part number M00201503046B0

  Maquet Cardiovascular, LLC · Devices · 2023-01-30
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cat

  Randox Laboratories · Devices · 2023-02-01
  Class II
• Baxter Preveleak Surgical Sealant, Product Codes: ADS201808

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with

  Ion Beam Applications S.A. · Devices · 2023-09-18
  Class II
• Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

  Abiomed, Inc. · Devices · 2023-05-26
  Class II
• KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxD

  Pro-Dex Inc · Devices · 2023-02-15
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit n

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-16
  Class II
• GS70 Salus Surgical Table, Product Code 18-070-70

  Skytron, LLC · Devices · 2023-08-01
  Class II
• 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal

  3M Company - Health Care Business · Devices · 2023-08-22
  Class II
• Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440

  Olympus Corporation of the Americas · Devices · 2023-08-10
  Class II
• PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z

  ETHICON, LLC · Devices · 2023-08-10
  Class II
• Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic proced

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors

  Steris Corporation · Devices · 2023-11-13
  Class II
• VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500

  Maquet Cardiovascular, LLC · Devices · 2023-03-06
  Class II
• Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140

  Datascope Corp. · Devices · 2023-02-28
  Class II
• Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SE

  Landauer · Devices · 2023-07-12
  Class II
• Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br

  Hologic, Inc · Devices · 2023-05-02
  Class II
• Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit num

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS

  Stryker Corporation · Devices · 2023-03-01
  Class II
• Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory

  Draeger Medical Systems, Inc. · Devices · 2023-04-05
  Class II
• DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

  Encore Medical, LP · Devices · 2023-08-04
  Class II
• SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

  Bebig Isotopentechnik Gmbh · Devices · 2023-10-17
  Class II
• FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SK

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radi

  Landauer · Devices · 2023-07-12
  Class II
• nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring do

  Landauer · Devices · 2023-07-12
  Class II
• SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568

  Avanos Medical, Inc. · Devices · 2023-04-24
  Class II
• Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Ac

  Olympus Corporation of the Americas · Devices · 2023-08-10
  Class II
• FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685

  Richard Wolf GmbH · Devices · 2023-03-24
  Class II
• ORAL B MOUTH SORE RINSE 237ML, SKU 999087

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• Lem Fertility LH Ovulation Test (Strip) REF 200-07

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK,

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

  Hiossen Inc. · Devices · 2023-04-06
  Class II
• AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, i

  MRP, LLC dba Aquabiliti · Devices · 2023-12-28
  Class II
• Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip

  Olympus Corporation of the Americas · Devices · 2023-02-23
  Class II
• Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

  Alcon Research, LLC · Devices · 2023-09-07
  Class II
• IntelliVue G7m Anesthesia Gas Module, Product Number 866173

  Philips North America · Devices · 2023-01-18
  Class II
• LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• OEC 9900 Systems with 9-inch Image Intensifier

  GE OEC Medical Systems, Inc · Devices · 2023-05-15
  Class II
• RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

  Appliedvr · Devices · 2023-02-27
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) con

  Folsom Metal Products, Inc. · Devices · 2023-10-30
  Class II
• Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

  Medtronic Inc. · Devices · 2023-12-07
  Class II
• 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

  SenTec AG · Devices · 2023-05-02
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; en

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010

  Stryker Corporation · Devices · 2023-09-11
  Class II
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

  Musculoskeletal Transplant Foundation, Inc. · Devices · 2023-12-22
  Class II
• Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

  Philips North America · Devices · 2023-06-12
  Class II
• One Step Ovulation Test REF 200-01

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G;

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicat

  Helena Laboratories, Corp. · Devices · 2023-05-02
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcar

  EMPATICA SRL · Devices · 2023-07-13
  Class II
• Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring d

  Landauer · Devices · 2023-07-12
  Class II
• STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612

  Diagnostica Stago, Inc. · Devices · 2023-03-22
  Class II
• Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit

  Edwards Lifesciences, LLC · Devices · 2023-10-04
  Class II
• Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 206

  GE Healthcare · Devices · 2023-03-28
  Class II
• Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M113582

  DATEX--OHMEDA, INC. · Devices · 2023-05-19
  Class II
• EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

  Encore Medical, LP · Devices · 2023-08-22
  Class II
• Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

  Iradimed Corporation · Devices · 2023-02-24
  Class II
• Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light sou

  Olympus Corporation of the Americas · Devices · 2023-11-06
  Class II
• INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE

  Canon Medical System, USA, INC. · Devices · 2023-06-22
  Class II
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Centricity Universal Viewer Workflow Manager, Image processing radiological system

  GE Healthcare · Devices · 2023-09-08
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-Z-450.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate post

  DePuy Mitek, Inc., a Johnson & Johnson Co. · Devices · 2023-04-13
  Class II
• Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

  Miach Orthopaedics · Devices · 2023-02-02
  Class II
• Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807

  Beaver Visitec International, Inc. · Devices · 2023-08-25
  Class II
• QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

  Medacta Usa Inc · Devices · 2023-03-08
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026,

  GE Healthcare · Devices · 2023-03-28
  Class II
• Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and

  Medtronic Neuromodulation · Devices · 2023-03-17
  Class II
• Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

  Beckman Coulter Inc. · Devices · 2023-07-12
  Class II
• PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator

  Inpeco S.A. · Devices · 2023-03-10
  Class II
• Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

  Wilson-Cook Medical Inc. · Devices · 2023-05-22
  Class II
• Azurion IGTS Fixed Systems

  Philips North America · Devices · 2023-10-04
  Class II
• epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

  Siemens Healthcare Diagnostics Inc · Devices · 2023-06-01
  Class II
• Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty

  Corin Ltd · Devices · 2023-10-13
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

  Siemens Medical Solutions USA, Inc. · Devices · 2023-01-16
  Class II
• Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, C

  Randox Laboratories Ltd. · Devices · 2023-06-21
  Class II
• Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro revers

  Abbott Molecular, Inc. · Devices · 2023-10-30
  Class II
• FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution conta

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric o

  Vero Biotech, LLC · Devices · 2023-11-17
  Class II
• Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, o

  Maquet Cardiovascular, LLC · Devices · 2023-09-19
  Class II
• Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination t

  Oakworks Inc · Devices · 2023-12-05
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosi

  Landauer · Devices · 2023-07-12
  Class II
• Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC

  North Coast Medical Inc · Devices · 2023-08-18
  Class II
• Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

  AURIS HEALTH INC · Devices · 2023-10-18
  Class II
• FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

  BioFire Diagnostics, LLC · Devices · 2023-12-14
  Class II
• ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M

  Zeus Scientific, Inc. · Devices · 2023-10-31
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015

  Stryker Corporation · Devices · 2023-09-11
  Class II
• Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

  Elekta, Inc. · Devices · 2023-04-06
  Class II
• Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile

  Peter Lazic Gmbh · Devices · 2023-07-14
  Class II
• Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK

  Covidien LP · Devices · 2023-12-21
  Class II
• ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-09
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

  Bard Peripheral Vascular Inc · Devices · 2023-08-10
  Class II
• Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

  Preat Corp · Devices · 2023-07-18
  Class II
• Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

  Biosense Webster, Inc. · Devices · 2023-02-21
  Class II
• Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination t

  Oakworks Inc · Devices · 2023-12-05
  Class II
• BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224

  CareFusion 303, Inc. · Devices · 2023-05-22
  Class II
• Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02

  Biomet, Inc. · Devices · 2023-11-02
  Class II
• RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122

  Medicrea International · Devices · 2023-07-12
  Class II
• Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590

  Aomori Olympus Co., Ltd. · Devices · 2023-07-27
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous join

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADUL

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in t

  Datascope Corp. · Devices · 2023-06-23
  Class II
• TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail

  Smith & Nephew, Inc. · Devices · 2023-07-24
  Class II
• Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7

  Medtronic MiniMed, Inc. · Devices · 2023-11-15
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• 6IN PRESSURE TUBING, List Number MX20617

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• Phoenix mKDR, digital mobile diagnostic x-ray system

  SEDECAL SA · Devices · 2023-02-06
  Class II
• EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si

  Philips North America Llc · Devices · 2023-08-31
  Class II
• Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore

  Becton Dickinson & Company · Devices · 2023-10-11
  Class II
• 24 BLOOD CULTURE KIT, REF DYNDH1632

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-01
  Class II
• Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached remov

  Davol, Inc. · Devices · 2023-04-25
  Class II
• Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.

  Maquet Cardiovascular, LLC · Devices · 2023-12-01
  Class II
• Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimu

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-30
  Class II
• Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adul

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)

  Covidien, LP · Devices · 2023-03-01
  Class II
• Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

  Steris Corporation · Devices · 2023-04-10
  Class II
• ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0

  Synovo Production · Devices · 2023-05-30
  Class II
• IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159

  Medicrea International · Devices · 2023-07-12
  Class II
• Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, sing

  Steris Corporation · Devices · 2023-03-17
  Class II
• Injection Needle, REF: 25207

  Karl Storz Endoscopy · Devices · 2023-10-24
  Class II
• 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-02-20
  Class II
• Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

  Aesculap Implant Systems LLC · Devices · 2023-05-18
  Class II
• GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Inten

  Xcision Medical Systems, LLC · Devices · 2023-11-30
  Class II
• REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

  Limacorporate S.p.A · Devices · 2023-05-30
  Class II
• Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

  Beckman Coulter, Inc. · Devices · 2023-05-17
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• GE Healthcare Vivid S70, ultrasound device

  GE Vingmed Ultrasound As · Devices · 2023-05-30
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

  Philips North America Llc · Devices · 2023-03-17
  Class II
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to

  Siemens Healthcare Diagnostics Inc · Devices · 2023-10-26
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Mo

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

  Baxter Healthcare Corporation · Devices · 2023-03-20
  Class II
• PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.50

  Limacorporate S.p.A · Devices · 2023-08-29
  Class II
• Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment o

  Sarnova HC, Llc · Devices · 2023-11-06
  Class II
• Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management

  CHANGE HEALTHCARE CANADA COMPANY · Devices · 2023-10-12
  Class II
• MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

  Datascope Corp. · Devices · 2023-06-23
  Class II
• INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

  PHASE SCIENTIFIC INTERNATIONAL LIMITED · Devices · 2023-10-25
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• MultiDiagnost-Eleva

  Philips Medical Systems Nederland B.V. · Devices · 2023-07-19
  Class II
• Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regar

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of mo

  Cytrellis Biosystems, Inc. · Devices · 2023-04-07
  Class II
• HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)

  AMD Medicom Inc. · Devices · 2023-12-21
  Class II
• Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA0

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Oculus Pentacam AXL Wave, Ref 70020, CE 0123

  Oculus Optikgeraete GMBH · Devices · 2023-08-08
  Class II
• STERILE PVP SLN KIT, REF DYNDM1097

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• Bard¿ Suction Connector with ENFit, REF EN0066000

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and manage

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

  B-K Medical A/S · Devices · 2023-11-30
  Class II
• Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip

  Zimmer, Inc. · Devices · 2023-02-27
  Class II
• Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

  Philips Respironics, Inc. · Devices · 2023-05-25
  Class II
• Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monit

  Integra LifeSciences Corp. · Devices · 2023-04-11
  Class II
• Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of t

  Securitas Healthcare LLC · Devices · 2023-02-06
  Class II
• SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

  C.R. Bard Inc · Devices · 2023-04-20
  Class II
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed t

  Siemens Healthcare Diagnostics Inc · Devices · 2023-10-26
  Class II
• Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1

  Draeger Medical Systems, Inc. · Devices · 2023-05-16
  Class II
• Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in c

  Olympus Corporation of the Americas · Devices · 2023-05-15
  Class II
• Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Acceler

  Inpeco S.A. · Devices · 2023-03-10
  Class II
• Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis

  Outset Medical, Inc. · Devices · 2023-01-24
  Class II
• Medex LOGICAL CATH LAB KIT, List Number M20754

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

  Encore Medical, LP · Devices · 2023-08-22
  Class II
• remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi

  Remel, Inc · Devices · 2023-08-14
  Class II
• Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-11-03
  Class II
• CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures

  Beaver Visitec International, Inc. · Devices · 2023-03-17
  Class II
• 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

  Heartware, Inc. · Devices · 2023-10-31
  Class II
• Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-09
  Class II
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

  TECHNO-PATH MANUFACTURING LTD. · Devices · 2023-08-25
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

  Diagnostica Stago, Inc. · Devices · 2023-03-22
  Class II
• HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monit

  Heartware, Inc. · Devices · 2023-05-16
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF,

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Sit to Stand STS500 Patient Lift

  Med-Mizer, Inc. · Devices · 2023-02-03
  Class II
• Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 7

  Philips Ultrasound, Inc. · Devices · 2023-10-09
  Class II
• Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

  Philips North America · Devices · 2023-03-20
  Class II
• nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR r

  Landauer · Devices · 2023-07-12
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-11-03
  Class II
• Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011,

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System -

  Aesculap Implant Systems LLC · Devices · 2023-02-23
  Class II
• Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

  Draegerwerk Ag & Co. Kgaa · Devices · 2023-11-17
  Class II
• LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANEST

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoom

  Hamamatsu Corporation · Devices · 2023-06-06
  Class II
• Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010

  Stryker Corporation · Devices · 2023-09-11
  Class II
• MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device

  Medacta Usa Inc · Devices · 2023-03-08
  Class II
• Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS

  Stryker Corporation · Devices · 2023-03-01
  Class II
• MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev

  Materialise N.V. · Devices · 2023-04-26
  Class II
• DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.

  Philips North America Llc · Devices · 2023-09-21
  Class II
• REV 2 Flowcell Capsule Spare, Part Number: C04154

  Beckman Coulter, Inc. · Devices · 2023-12-19
  Class II
• wDR 2.2 Mobile Digital Diagnostic X-Ray System

  SEDECAL SA · Devices · 2023-05-23
  Class II
• DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

  Beckman Coulter, Inc. · Devices · 2023-04-05
  Class II
• JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, J

  SPINEART SA · Devices · 2023-03-16
  Class II
• Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 5081

  C.R. Bard Inc · Devices · 2023-04-20
  Class II
• Sensica Urine Output System, Catalog Number SCCS1002

  C.R. Bard Inc · Devices · 2023-11-15
  Class II
• Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

  SoClean, Inc · Devices · 2023-11-15
  Class II
• Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote

  Abiomed, Inc. · Devices · 2023-12-06
  Class II
• Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

  Preat Corp · Devices · 2023-07-18
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMI

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUST

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Sperm separation media are used to separate motile sperm from other constituents of semen.

  Fujifilm Irvine Scientific, Inc. · Devices · 2023-11-02
  Class II
• VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-10-10
  Class II
• Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

  Datascope Corp. · Devices · 2023-02-28
  Class II
• INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-16
  Class II
• Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284

  Edwards Lifesciences, LLC · Devices · 2023-10-04
  Class II
• Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

  Cepheid · Devices · 2023-04-24
  Class II
• PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological sam

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• Incisive CT-Computed Tomography X-Ray System Model: 728143

  Philips North America · Devices · 2023-04-25
  Class II
• Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

  Accuray Incorporated · Devices · 2023-08-03
  Class II
• Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

  Davol, Inc. · Devices · 2023-04-25
  Class II
• Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

  Olympus Corporation of the Americas · Devices · 2023-12-04
  Class II
• Phantom TTC Nail, 10.0 X 200mm, Right

  Paragon 28, Inc. · Devices · 2023-12-21
  Class II
• SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing inte

  Meridian Bioscience Inc · Devices · 2023-10-19
  Class II
• Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

  Steris Corporation · Devices · 2023-12-12
  Class II
• 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i

  BioFire Diagnostics, LLC · Devices · 2023-11-27
  Class II
• NOxBOXi Nitric Oxide Delivery System

  NOXBOX LTD · Devices · 2023-07-19
  Class II
• Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunc

  Stryker Corporation · Devices · 2023-01-25
  Class II
• ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and ches

  Maquet Cardiovascular, LLC · Devices · 2023-06-28
  Class II
• PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extr

  Entopsis , Inc. · Devices · 2023-02-21
  Class II
• To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

  Luminex Corporation · Devices · 2023-06-05
  Class II
• Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial c

  Spectrum Medical Ltd. · Devices · 2023-03-13
  Class II
• Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO

  Windstone Medical Packaging, Inc. · Devices · 2023-04-24
  Class II
• Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchroniza

  Abbott Medical · Devices · 2023-08-16
  Class II
• Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUR

  Medtronic Neurosurgery · Devices · 2023-06-13
  Class II
• FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo

  Edwards Lifesciences, LLC · Devices · 2023-10-04
  Class II
• BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesi

  CareFusion 303, Inc. · Devices · 2023-04-05
  Class II
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Beside panel FRU (Field Replacement Units) Kits

  DATEX--OHMEDA, INC. · Devices · 2023-05-19
  Class II
• SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

  Young Dental Manufacturing I, LLC · Devices · 2023-10-06
  Class II
• Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level

  Randox Laboratories Ltd. · Devices · 2023-11-13
  Class II
• Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

  Qiagen Sciences LLC · Devices · 2023-04-28
  Class II
• STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medica

  Scican Ltd. · Devices · 2023-06-22
  Class II
• LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LE

  Smith & Nephew, Inc. · Devices · 2023-05-02
  Class II
• Intera 1.5T Power/Pulsar

  Philips North America Llc · Devices · 2023-10-23
  Class II
• ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01

  Synovo Production · Devices · 2023-05-30
  Class II
• Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

  Philips North America · Devices · 2023-06-12
  Class II
• Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Che

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-08-09
  Class II
• RANDOX Total Bilirubin.

  Randox Laboratories Ltd. · Devices · 2023-10-11
  Class II
• TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036

  Edwards Lifesciences, LLC · Devices · 2023-10-04
  Class II
• Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.

  Edwards Lifesciences, LLC · Devices · 2023-02-14
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. RO

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with

  Onkos Surgical, Inc. · Devices · 2023-12-22
  Class II
• Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. O

  Cook Vandergrift, Inc. · Devices · 2023-07-24
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CP

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 1

  Townsend Design · Devices · 2023-09-23
  Class II
• ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

  Siemens Medical Solutions USA, Inc · Devices · 2023-10-17
  Class II
• Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

  Beckman Coulter, Inc. · Devices · 2023-03-15
  Class II
• STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59

  Diagnostica Stago, Inc. · Devices · 2023-03-22
  Class II
• PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the

  Datascope Corp. · Devices · 2023-06-23
  Class II
• Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

  Avanos Medical, Inc. · Devices · 2023-02-03
  Class II
• CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary

  St. Jude Medical · Devices · 2023-02-07
  Class II
• BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

  Bio-Rad Laboratories, Inc. · Devices · 2023-02-21
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu

  Olympus Corporation of the Americas · Devices · 2023-05-04
  Class II
• Intera 1.5T

  Philips North America Llc · Devices · 2023-10-23
  Class II
• Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

  Howmedica Osteonics Corp. · Devices · 2023-05-03
  Class II
• AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their s

  Beckman Coulter Biomedical Division · Devices · 2023-09-06
  Class II
• LITe Decompression Snake Arm, REF 48080230

  Stryker Spine · Devices · 2023-11-01
  Class II
• GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

  Ansell Healthcare Products LLC · Devices · 2023-08-03
  Class II
• greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in

  Greiner Bio-One North America, Inc. · Devices · 2023-03-31
  Class II
• ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedur

  Siemens Medical Solutions USA, Inc · Devices · 2023-06-19
  Class II
• Integris-Allura IGTS Fixed Systems

  Philips North America · Devices · 2023-10-04
  Class II
• vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ven

  Vyaire Medical · Devices · 2023-10-27
  Class II
• Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

  Philips North America Llc · Devices · 2023-11-30
  Class II
• bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

  Vyaire Medical · Devices · 2023-05-05
  Class II
• QUADROX-iR, used during cardiopulmonary bypass Model Item No. Descriptio

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1

  Invacare Corporation · Devices · 2023-06-15
  Class II
• Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting

  Zimmer Surgical Inc · Devices · 2023-09-05
  Class II
• Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from clear

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites

  Cordis US Corp · Devices · 2023-11-28
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

  GRAMERCY EXTREMITY ORTHOPEDICS · Devices · 2023-04-04
  Class II
• Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the h

  Draeger Medical Systems, Inc. · Devices · 2023-04-05
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Mode

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• LYFO-DISK, P. venetum, Catalog number 0794L

  Microbiologics Inc · Devices · 2023-10-18
  Class II
• Perifix¿ / Epidural anesthesia kit (10 count carton)

  B. Braun Medical, Inc. · Devices · 2023-06-05
  Class II
• bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

  Vyaire Medical · Devices · 2023-05-05
  Class II
• HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public

  HeartSine Technologies Ltd · Devices · 2023-04-26
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen

  BioFire Diagnostics, LLC · Devices · 2023-10-17
  Class II
• Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30

  ICU Medical Inc · Devices · 2023-07-13
  Class II
• Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets

  Quest Medical, Inc. · Devices · 2023-07-14
  Class II
• Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREA

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020

  Physio-Control, Inc. · Devices · 2023-09-29
  Class II
• HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip

  Howmedica Osteonics Corp. · Devices · 2023-12-22
  Class II
• Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-08
  Class II
• Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P

  Permobil · Devices · 2023-05-10
  Class II
• BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

  Breg Inc · Devices · 2023-09-13
  Class II
• Olympus Bronchovideoscope, Models BF-XT190.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35m

  Folsom Metal Products, Inc. · Devices · 2023-10-30
  Class II
• UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeut

  UFSK - International OSYS Gmbh · Devices · 2023-05-31
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Numbe

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE

  Full Vision Inc · Devices · 2023-05-12
  Class II
• FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure mo

  Edwards Lifesciences, LLC · Devices · 2023-10-04
  Class II
• Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon

  Stryker GmbH · Devices · 2023-02-07
  Class II
• In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

  BioFire Diagnostics, LLC · Devices · 2023-02-01
  Class II
• Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fr

  Waldemar Link GmbH & Co. KG (Mfg Site) · Devices · 2023-07-03
  Class II
• Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

  Exactech, Inc. · Devices · 2023-11-21
  Class II
• Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

  Biomet, Inc. · Devices · 2023-11-02
  Class II
• ProCuity bed series, model number 3009, item number: 300900000000,

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty su

  Howmedica Osteonics Corp. · Devices · 2023-03-10
  Class II
• RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)

  Randox Laboratories Ltd. · Devices · 2023-09-06
  Class II
• Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO

  Windstone Medical Packaging, Inc. · Devices · 2023-04-24
  Class II
• THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including singl

  Olympus Corporation of the Americas · Devices · 2023-09-12
  Class II
• Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

  Covidien · Devices · 2023-11-16
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous a

  Wolf, Henke Sass, Gmbh · Devices · 2023-07-27
  Class II
• Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

  Covidien, LLC · Devices · 2023-05-22
  Class II
• PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B023165

  Medicrea International · Devices · 2023-07-12
  Class II
• Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-12-15
  Class II
• VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20-

  Ortho-Clinical Diagnostics · Devices · 2023-05-08
  Class II
• MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

  Unetixs Vascular, Inc. · Devices · 2023-02-10
  Class II
• Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• Cirq Arm System 2.0

  Brainlab AG · Devices · 2023-03-02
  Class II
• Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

  Zimmer Biomet Spine Inc. · Devices · 2023-10-16
  Class II
• Ultraview SL (UVSL) Command Module, Model 91496

  Spacelabs Healthcare, Inc. · Devices · 2023-04-12
  Class II
• Remington MEDICAL Drainage Bag, REF 600-D;

  Remington Medical, Inc. · Devices · 2023-11-03
  Class II
• Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c)

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant com

  Encore Medical, LP · Devices · 2023-09-25
  Class II
• Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M.

  Onkos Surgical, Inc. · Devices · 2023-09-01
  Class II
• BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform.

  Becton Dickinson & Co. · Devices · 2023-03-22
  Class II
• Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)

  Covidien, LP · Devices · 2023-03-01
  Class II
• INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-16
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Mo

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-01
  Class II
• Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005

  Stryker Corporation · Devices · 2023-09-11
  Class II
• procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 2

  Advance Medical Designs, Inc. · Devices · 2023-07-07
  Class II
• Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g

  FUJIFILM Healthcare Americas Corporation · Devices · 2023-02-27
  Class II
• Snapshot NIR, REF: KD204

  KENT IMAGING, INC. · Devices · 2023-10-30
  Class II
• VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-10-10
  Class II
• Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, M

  Cosmedent, Inc. · Devices · 2023-07-20
  Class II
• Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

  Medtronic Sofamor Danek USA Inc · Devices · 2023-06-06
  Class II
• Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Lamine

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• VERIQUICK PREGNANCY TEST 1CT, SKU 901260

  Family Dollar Stores, Llc. · Devices · 2023-10-04
  Class II
• COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tu

  Covidien · Devices · 2023-02-10
  Class II
• Citrine QTRAP Mass Spectrometer, Part Number 5063685

  AB Sciex, LLC · Devices · 2023-08-30
  Class II
• Pediatric Urology Wolson Pack, REF BPPU55A

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

  Siemens Healthcare Diagnostics Inc · Devices · 2023-06-01
  Class II
• Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

  ROi CPS LLC · Devices · 2023-03-22
  Class II
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• SofTech Pressure-Sensing Wheelchair Cushions

  Aquila Corporation · Devices · 2023-07-06
  Class II
• OEC 9800 Systems with 9-inch Image Intensifier

  GE OEC Medical Systems, Inc · Devices · 2023-05-15
  Class II
• GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for

  Baxter Healthcare Corporation · Devices · 2023-03-27
  Class II
• Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY

  Merit Medical Systems, Inc. · Devices · 2023-11-06
  Class II
• NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

  Cardinal Health 200, LLC · Devices · 2023-06-16
  Class II
• Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible

  Olympus Corporation of the Americas · Devices · 2023-05-26
  Class II
• Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re

  Hologic, Inc. · Devices · 2023-09-14
  Class II
• Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making d

  Edge Biologicals Inc · Devices · 2023-10-02
  Class II
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

  Merit Medical Systems, Inc. · Devices · 2023-04-22
  Class II
• Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

  Randox Laboratories Ltd. · Devices · 2023-08-03
  Class II
• Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravas

  Edwards Lifesciences, LLC · Devices · 2023-10-04
  Class II
• Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitorin

  Landauer · Devices · 2023-07-12
  Class II
• Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump

  Smiths Medical ASD Inc. · Devices · 2023-08-16
  Class II
• IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

  Medicrea International · Devices · 2023-07-12
  Class II
• Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Vers

  Turncare, Inc · Devices · 2023-08-10
  Class II
• Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

  Philips North America · Devices · 2023-04-25
  Class II
• global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult

  CooperSurgical, Inc. · Devices · 2023-12-20
  Class II
• RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to supp

  RAYSEARCH LABORATORIES AB · Devices · 2023-07-17
  Class II
• Med-Riser MR600 Patient Lift

  Med-Mizer, Inc. · Devices · 2023-02-03
  Class II
• Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

  NeuroLogica Corporation · Devices · 2023-03-08
  Class II
• BD Pyxis MedStation ES AUX, REF 324

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet &

  Microtek Medical Inc. · Devices · 2023-06-23
  Class II
• Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SE

  Landauer · Devices · 2023-07-12
  Class II
• Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03

  Getinge Usa Sales Inc · Devices · 2023-11-08
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, M

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

  DePuy Orthopaedics, Inc. · Devices · 2023-02-15
  Class II
• Alinity c Iron Reagent, Reference Number 08P3920

  Sentinel CH SpA · Devices · 2023-09-29
  Class II
• TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

  MICROVENTION INC. · Devices · 2023-12-21
  Class II
• General Pack, REF BBGP31C

  American Contract Systems, Inc. · Devices · 2023-09-01
  Class II
• 3M Attest Steam Chemical Integrators, REF 1243A

  3M Company - Health Care Business · Devices · 2023-04-06
  Class II
• ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

  Wright Medical Technology, Inc. · Devices · 2023-02-02
  Class II
• COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

  Beckman Coulter, Inc. · Devices · 2023-05-31
  Class II
• Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

  Conformis, Inc. · Devices · 2023-06-16
  Class II
• VITROS Immunodiagnostic Products Troponin I ES Calibrators

  ORTHO-CLINICAL DIAGNOSTICS · Devices · 2023-06-05
  Class II
• GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00

  Instrumentation Laboratory · Devices · 2023-09-29
  Class II
• Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 301

  Smiths Medical ASD Inc. · Devices · 2023-12-19
  Class II
• MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-12-21
  Class II
• DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elb

  Smiths Medical ASD Inc. · Devices · 2023-04-05
  Class II
• Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c

  Luminex Corporation · Devices · 2023-11-07
  Class II
• LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for i

  Abiomed, Inc. · Devices · 2023-11-07
  Class II
• VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS

  Covidien LP · Devices · 2023-03-22
  Class II
• Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

  Cepheid · Devices · 2023-04-24
  Class II
• ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo

  Olympus Corporation of the Americas · Devices · 2023-10-02
  Class II
• Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / Q

  Baxter Healthcare Corporation · Devices · 2023-12-08
  Class II
• Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

  Medtronic Neuromodulation · Devices · 2023-10-19
  Class II
• Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

  Beckman Coulter Inc. · Devices · 2023-04-05
  Class II
• Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

  Shirakawa Olympus Co., Ltd. · Devices · 2023-12-04
  Class II
• Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

  Smiths Medical Asd Inc · Devices · 2023-11-10
  Class II
• QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

  Wilson-Cook Medical Inc. · Devices · 2023-11-03
  Class II
• Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

  PHILIPS MEDICAL SYSTEMS · Devices · 2023-12-13
  Class II
• Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

  Biomet, Inc. · Devices · 2023-10-09
  Class II
• MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosur

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-08-03
  Class II
• EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.

  Boston Scientific Corporation · Devices · 2023-12-19
  Class II
• Flow-i C40 Anesthesia System, model 6677400

  Getinge Usa Sales Inc · Devices · 2023-12-11
  Class II
• Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin

  Phadia US Inc · Devices · 2023-05-01
  Class II
• NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number

  Angiodynamics, Inc. · Devices · 2023-03-02
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS

  Covidien LP · Devices · 2023-03-22
  Class II
• Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

  Preat Corp · Devices · 2023-07-18
  Class II
• Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patien

  Arjohuntleigh Magog, Inc. · Devices · 2023-02-17
  Class II
• YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

  Surgical Innovations Ltd · Devices · 2023-03-28
  Class II
• SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Pre

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54)

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump

  Smiths Medical ASD Inc. · Devices · 2023-08-16
  Class II
• SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table

  Oakworks Inc · Devices · 2023-12-05
  Class II
• Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094

  DATEX--OHMEDA, INC. · Devices · 2023-05-19
  Class II
• TECNIS Toric II OptiBlue IOL Models ZCW

  Johnson & Johnson Surgical Vision, Inc. · Devices · 2023-12-12
  Class II
• AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

  Avanos Medical, Inc. · Devices · 2023-04-24
  Class II
• Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1

  SunMed Holdings, LLC · Devices · 2023-10-11
  Class II
• TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE

  Full Vision Inc · Devices · 2023-05-12
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System

  GE Healthcare · Devices · 2023-09-14
  Class II
• Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.

  Olympus Corporation of the Americas · Devices · 2023-07-27
  Class II
• AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me

  Avanos Medical, Inc. · Devices · 2023-10-13
  Class II
• Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed fo

  Philips North America Llc · Devices · 2023-10-09
  Class II
• Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012,

  GE Healthcare · Devices · 2023-03-28
  Class II
• Accure Laser System, Model: PFMS00004

  Accure Acne, Inc · Devices · 2023-12-06
  Class II
• Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device

  Carefusion 2200 Inc · Devices · 2023-07-13
  Class II
• BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

  Becton Dickinson & Co. · Devices · 2023-09-12
  Class II
• Model A710 Intellis Clinician Programmer Application, version 2.0.97

  Medtronic Neuromodulation · Devices · 2023-12-19
  Class II
• Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

  Bard Peripheral Vascular Inc · Devices · 2023-02-28
  Class II
• Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

  Boston Scientific Corporation · Devices · 2023-07-27
  Class II
• HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840

  Maquet Medical Systems USA · Devices · 2023-05-18
  Class II
• EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

  Encore Medical, LP · Devices · 2023-02-28
  Class II
• Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips

  Universal Meditech Inc. · Devices · 2023-05-22
  Class II
• TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927

  Full Vision Inc · Devices · 2023-05-12
  Class II
• ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-09
  Class II
• thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.

  Solta Medical Inc · Devices · 2023-02-16
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• Coapt ControlSeal Electrode, cutaneous EMG Electrode

  Coapt LLC · Devices · 2023-10-02
  Class II
• Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

  Exactech, Inc. · Devices · 2023-06-05
  Class II
• FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685

  Richard Wolf GmbH · Devices · 2023-03-24
  Class II
• BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

  B. Braun Medical, Inc. · Devices · 2023-09-26
  Class II
• BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desk

  CareFusion 303, Inc. · Devices · 2023-09-06
  Class II
• SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 1

  TEI Biosciences, Inc. · Devices · 2023-05-23
  Class II
• SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

  Limacorporate S.p.A · Devices · 2023-02-21
  Class II
• Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

  Wilson-Cook Medical Inc. · Devices · 2023-05-22
  Class II
• TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

  Full Vision Inc · Devices · 2023-05-12
  Class II
• EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for t

  Phadia US Inc · Devices · 2023-05-01
  Class II
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

  Datascope Corp. · Devices · 2023-07-31
  Class II
• GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

  Aizu Olympus Co., Ltd. · Devices · 2023-10-16
  Class II
• ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human seru

  Siemens Healthcare Diagnostics, Inc. · Devices · 2023-01-09
  Class II
• Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy C

  Spectranetics Corporation · Devices · 2023-11-15
  Class II
• COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha

  Avanos Medical, Inc. · Devices · 2023-08-01
  Class II
• BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are design

  Becton Dickinson & Company · Devices · 2023-02-01
  Class II
• AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

  PATH · Devices · 2023-09-26
  Class II
• Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablat

  Aesculap Implant Systems LLC · Devices · 2023-03-21
  Class II
• Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Pres

  Cardinal Health 200, LLC · Devices · 2023-08-16
  Class II
• GE Healthcare Vivid S60, ultrasound device

  GE Vingmed Ultrasound As · Devices · 2023-05-30
  Class II
• Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix

  Medtronic Sofamor Danek USA Inc · Devices · 2023-09-26
  Class II
• PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number

  Becton Dickinson & Company · Devices · 2023-11-16
  Class II
• BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES

  CareFusion 303, Inc. · Devices · 2023-02-14
  Class II
• TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

  Johnson & Johnson Surgical Vision, Inc. · Devices · 2023-07-06
  Class II
• XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6A

  Baxter Healthcare Corporation · Devices · 2023-12-08
  Class II
• Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Num

  Onkos Surgical, Inc. · Devices · 2023-09-01
  Class II
• MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

  Unetixs Vascular, Inc. · Devices · 2023-02-10
  Class II
• Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical intervent

  Getinge Usa Sales Inc · Devices · 2023-09-06
  Class II
• LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

  BioFire Diagnostics, LLC · Devices · 2023-02-01
  Class II
• TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization

  Synthes (USA) Products LLC · Devices · 2023-02-01
  Class II
• OEC Elite Systems with 9-inch Image Intensifier

  GE OEC Medical Systems, Inc · Devices · 2023-05-15
  Class II
• BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural lig

  T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Devices · 2023-05-04
  Class II
• binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoe

  Binx Health, Inc. · Devices · 2023-03-29
  Class II
• Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HI

  American Contract Systems, Inc. · Devices · 2023-11-29
  Class II
• Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-08
  Class II
• HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cl

  Boston Scientific Corporation · Devices · 2023-05-25
  Class II
• D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.

  Peter Lazic Gmbh · Devices · 2023-10-06
  Class II
• HoverMatt, 39" W x 78" L, REF: HM39SPU-B

  Stryker Sustainability Solutions · Devices · 2023-06-21
  Class II
• FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

  Abbott Diabetes Care, Inc. · Devices · 2023-02-09
  Class II
• LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08

  Linkbio Corp. · Devices · 2023-03-21
  Class II
• Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CM

  Baxter Healthcare Corporation · Devices · 2023-12-06
  Class II
• Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

  Abiomed, Inc. · Devices · 2023-10-10
  Class II
• VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitat

  Ortho-Clinical Diagnostics, INc. · Devices · 2023-10-25
  Class II
• Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, U

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class II
• Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the br

  Integra LifeSciences Corp. · Devices · 2023-10-19
  Class II
• ProCuity bed series, model number 3009, item number: 3009PX-L-200

  Stryker Medical Division of Stryker Corporation · Devices · 2023-08-30
  Class II
• ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation

  Instrumentation Laboratory · Devices · 2023-02-03
  Class II
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

  Aesculap Implant Systems LLC · Devices · 2023-07-20
  Class II
• Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03

  Onkos Surgical, Inc. · Devices · 2023-09-01
  Class II
• ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with

  Onkos Surgical, Inc. · Devices · 2023-12-22
  Class II
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Num

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

  Maquet Cardiovascular, LLC · Devices · 2023-10-31
  Class II
• nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosi

  Landauer · Devices · 2023-07-12
  Class II
• Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120

  C.R. Bard Inc · Devices · 2023-12-20
  Class II
• INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT402

  Medtronic Sofamor Danek USA Inc · Devices · 2023-02-16
  Class II
• Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVE

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-15
  Class II
• EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado

  Olympus Corporation of the Americas · Devices · 2023-11-10
  Class II
• Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

  Philips North America · Devices · 2023-04-25
  Class II
• Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

  Coloplast Manufacturing US, LLC · Devices · 2023-03-01
  Class II
• DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709

  Howmedica Osteonics Corp. · Devices · 2023-12-01
  Class II
• Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G

  Bard Peripheral Vascular Inc · Devices · 2023-11-08
  Class II
• Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Devices · 2023-12-07
  Class II
• BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

  Young Dental Manufacturing I, LLC · Devices · 2023-05-23
  Class II
• REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

  Limacorporate S.p.A · Devices · 2023-05-30
  Class II
• PVP SOLUTION SING STRL, REF DYNDA1858

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-11-03
  Class II
• Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS

  Stryker Corporation · Devices · 2023-03-01
  Class II
• Atrium Pneumostat Chest Drain Valve, Part Number 16100

  Atrium Medical Corporation · Devices · 2023-03-01
  Class II
• MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PAC

  MEDLINE INDUSTRIES, LP - Northfield · Devices · 2023-05-18
  Class II
• Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B

  Philips Respironics, Inc. · Devices · 2023-11-27
  Class II
• NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC

  Landauer · Devices · 2023-07-12
  Class II
• PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

  Smiths Medical ASD Inc. · Devices · 2023-07-18
  Class II
• EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.

  Staar Surgical Company · Devices · 2023-09-29
  Class II
• Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Ma

  Cipla USA, Inc. · Drugs · 2026-02-18
  Class III
• Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US

  Eugia US LLC · Drugs · 2026-05-18
  Class III
• Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-

  Island Kinetics, Inc. d.b.a. CoValence Laboratories · Drugs · 2026-03-18
  Class III
• Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous U

  Slate Run Pharmaceuticals · Drugs · 2026-02-12
  Class III
• Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl.

  Island Kinetics, Inc. d.b.a. CoValence Laboratories · Drugs · 2026-03-18
  Class III
• Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Roman

  Premier Dental Products Co · Drugs · 2026-04-14
  Class III
• Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 To

  Unichem Pharmaceuticals USA Inc. · Drugs · 2026-01-21
  Class III
• Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141

  Annora Pharma Private Limited · Drugs · 2026-02-03
  Class III
• Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, I

  AVEVA Drug Delivery Systems, Inc. · Drugs · 2026-05-14
  Class III
• busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, A

  Unichem Pharmaceuticals USA Inc. · Drugs · 2026-04-13
  Class III
• Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Hea

  Amerisource Health Services LLC · Drugs · 2026-05-01
  Class III
• Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by

  Water-Jel Technologies, LLC · Drugs · 2026-04-07
  Class III
• Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Inco

  Golden State Medical Supply Inc. · Drugs · 2026-04-27
  Class III
• Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696

  Fresenius Kabi USA, LLC · Drugs · 2026-05-14
  Class III
• Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, In

  Golden State Medical Supply Inc. · Drugs · 2026-04-27
  Class III
• PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie co

  AbbVie Inc. · Drugs · 2026-05-18
  Class III
• Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By:

  Island Kinetics, Inc. d.b.a. CoValence Laboratories · Drugs · 2026-03-18
  Class III
• Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence

  Cipla USA, Inc. · Drugs · 2026-02-18
  Class III
• Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American He

  Amerisource Health Services LLC · Drugs · 2026-05-01
  Class III
• Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,

  Sagent Pharmaceuticals · Drugs · 2026-05-04
  Class III
• Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performanc

  Avantor Performance Materials LLC · Drugs · 2026-03-31
  Class III
• Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent

  American Regent, Inc. · Drugs · 2026-04-16
  Class III
• Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphat

  Radnostix · Drugs · 2026-02-19
  Class III
• Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral

  Amneal Pharmaceuticals, LLC · Drugs · 2026-06-03
  Class III
• Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,

  Lannett Company Inc. · Drugs · 2026-04-24
  Class III
• Heraeus, PALAMIX uno. Material Number: 66057893.

  Heraeus Medical GmbH (Dental Division) · Devices · 2026-03-25
  Class III
• Battery Charging Station; Model: 0998-00-0802;

  Datascope Corp. · Devices · 2026-02-06
  Class III
• Heraeus, PALAMIX duo. Material Number: 66057897.

  Heraeus Medical GmbH (Dental Division) · Devices · 2026-03-25
  Class III
• WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

  Straumann USA LLC · Devices · 2026-01-06
  Class III
• Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per ca

  Imprimis NJOF, LLC · Drugs · 2025-07-09
  Class III
• Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Min

  Haleon US Holdings LLC · Drugs · 2025-08-05
  Class III
• traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Di

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2025-12-19
  Class III
• Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-11-21
  Class III
• Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical

  PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Drugs · 2025-01-07
  Class III
• TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 452

  Consumer Product Partners, LLC · Drugs · 2025-08-25
  Class III
• Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC

  Consumer Product Partners, LLC · Drugs · 2025-08-25
  Class III
• Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Stre

  Cipla USA, Inc. · Drugs · 2025-12-22
  Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

  Granules Pharmaceuticals Inc. · Drugs · 2025-08-28
  Class III
• Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in

  Dr. Reddy's Laboratories, Inc. · Drugs · 2025-11-11
  Class III
• Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-03-04
  Class III
• parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Hale

  Haleon US Holdings LLC · Drugs · 2025-12-26
  Class III
• Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905

  AvKARE · Drugs · 2025-06-26
  Class III
• Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufa

  SOMERSET THERAPEUTICS LLC · Drugs · 2025-11-26
  Class III
• Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. o

  JB Chemicals and Pharmaceuticals Ltd · Drugs · 2025-09-12
  Class III
• Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen,

  Orient Pharma Co., Ltd. Yunlin Plant · Drugs · 2025-06-11
  Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

  Granules Pharmaceuticals Inc. · Drugs · 2025-08-28
  Class III
• Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, De

  STAQ Pharma, Inc. · Drugs · 2025-10-09
  Class III
• Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA

  Kowa Pharmaceuticals America · Drugs · 2025-02-24
  Class III
• Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, I

  Cipla USA, Inc. · Drugs · 2025-07-24
  Class III
• Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

  Letco Medical LLC · Drugs · 2025-09-12
  Class III
• BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Compa

  The W.S. Badger Company, Inc. · Drugs · 2025-01-17
  Class III
• Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-12-30
  Class III
• Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured

  Endo USA, Inc. · Drugs · 2025-10-10
  Class III
• Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

  Boothwyn Pharmacy LLC · Drugs · 2025-07-09
  Class III
• Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distr

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2025-03-04
  Class III
• Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edm

  Qualgen, LLC · Drugs · 2025-06-16
  Class III
• Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by

  Macleods Pharmaceuticals Ltd · Drugs · 2025-06-11
  Class III
• Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder

  Winder Laboratories, LLC · Drugs · 2025-11-26
  Class III
• Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15

  Imprimis NJOF, LLC · Drugs · 2025-02-24
  Class III
• Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway

  NOVADOZ PHARMACEUTICALS LLC · Drugs · 2025-12-15
  Class III
• Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured

  Endo USA, Inc. · Drugs · 2025-10-10
  Class III
• HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake

  OurPharma LLC · Drugs · 2025-04-15
  Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

  Granules Pharmaceuticals Inc. · Drugs · 2025-08-28
  Class III
• Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

  Appco Pharma LLC · Drugs · 2025-01-16
  Class III
• Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactur

  SOMERSET THERAPEUTICS LLC · Drugs · 2025-11-26
  Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

  Granules Pharmaceuticals Inc. · Drugs · 2025-08-28
  Class III
• Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavi

  Teva Pharmaceuticals USA, Inc · Drugs · 2025-11-07
  Class III
• Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906

  AvKARE · Drugs · 2025-06-26
  Class III
• READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured

  Medline Industries, LP · Drugs · 2025-08-19
  Class III
• Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prad

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-11-18
  Class III
• Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. o

  JB Chemicals and Pharmaceuticals Ltd · Drugs · 2025-09-12
  Class III
• Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-03-04
  Class III
• Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufacture

  SOMERSET THERAPEUTICS LLC · Drugs · 2025-11-26
  Class III
• Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Lim

  Alembic Pharmaceuticals Limited · Drugs · 2025-12-16
  Class III
• Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd

  STAQ Pharma, Inc. · Drugs · 2025-10-09
  Class III
• FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42n

  STAQ Pharma, Inc. · Drugs · 2025-10-09
  Class III
• Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen,

  Orient Pharma Co., Ltd. Yunlin Plant · Drugs · 2025-06-11
  Class III
• Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Us

  Imprimis NJOF, LLC · Drugs · 2025-10-20
  Class III
• Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmace

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2025-11-26
  Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

  Granules Pharmaceuticals Inc. · Drugs · 2025-08-28
  Class III
• Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured

  Endo USA, Inc. · Drugs · 2025-10-10
  Class III
• Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc.

  Macleods Pharmaceuticals Ltd · Drugs · 2025-05-29
  Class III
• Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceutical

  Alembic Pharmaceuticals Limited · Drugs · 2025-10-10
  Class III
• Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by

  Endo USA, Inc. · Drugs · 2025-09-05
  Class III
• Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2025-05-19
  Class III
• Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by

  Endo USA, Inc. · Drugs · 2025-10-10
  Class III
• TRANSDUCER L12-5 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

  Diversatek Healthcare · Devices · 2025-06-04
  Class III
• Penner Pacific Bathing Spa, Model Numbers 360020-1P

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• C6-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Apo B Reagent, REF: OSR6143

  Beckman Coulter Ireland, Inc. · Devices · 2025-04-23
  Class III
• L12-5 38mm Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• HemosIL SynthAFax. Partial Thromboplastin Time Tests.

  Instrumentation Laboratory · Devices · 2025-11-18
  Class III
• C8-4v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• L9-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• X7-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips S5-2 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• S9-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C8-5 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• mC7-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C5-2 Lumify Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• X6-1 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C9-3v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• L12-4 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• BP10-5ec Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• SCNHD LA L7-4 HDI Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• L8-4 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• 7.5MHZ Endo Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spa

  Orthofix U.S. LLC · Devices · 2025-11-03
  Class III
• L10-4LAP Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C10-4ec Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• X5-1 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Penner Pacific Bathing Spa, Model Numbers 360020-1EP

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• C8-4v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• VL13-5 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• S4-1 Lumify Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S4-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• OMNI II TEE Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• AcoSound. Model Number: LW12-BTE-M

  HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. · Devices · 2025-04-25
  Class III
• C9-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips S4-1 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• Akreos, SKU: AO60P0300. Akreos intraocular lenses

  Bausch & Lomb Surgical, Inc. · Devices · 2025-06-06
  Class III
• 3D9-3v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• L18-5 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• D2cwc Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Cardiosave Rescue

  Datascope Corp. · Devices · 2025-10-23
  Class III
• mL26-8 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C6-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• eL18-4 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips X3-1 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• Philips OMNI II TEE Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl

  Accriva Diagnostics, Inc. · Devices · 2025-10-21
  Class III
• mC12-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult

  POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC · Devices · 2025-10-06
  Class III
• L15-7io Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• X5-1c Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Cardiosave Hybrid

  Datascope Corp. · Devices · 2025-10-23
  Class III
• Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH

  CareFusion 303, Inc. · Devices · 2025-07-10
  Class III
• L12-4 Lumify Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S7-3t Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S5-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Pro

  LUMITHERA INC · Devices · 2025-05-07
  Class III
• 3D6-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C9-4v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S3-1 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S8-3t Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips L17-5 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• D5cwc Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Transducer C10-3v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• X11-4t Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-600

  Orthofix U.S. LLC · Devices · 2025-11-03
  Class III
• L12-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• Mini Multi TEE Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3

  Orthofix U.S. LLC · Devices · 2025-11-03
  Class III
• Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L,

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 3

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• Penner Pacific Bathing Spa, Model Numbers 860010-1L

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• S4-1 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• c5-1 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• FloPatch FP120, REF: FP120-FOT01-005

  Flosonics Medical (R/A 1929803 ONTARIO CORP.) · Devices · 2025-08-07
  Class III
• V6-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips Mini Multi TEE Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• C9-4 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total

  DRG International, Inc. · Devices · 2025-06-04
  Class III
• Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• Philips OMNI III TEE Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• L12-5 50 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• V9-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• XL14-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• X8-2t Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C9-3io Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• L11-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• OMNI III TEE Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• D2TCD Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips 3D6-2 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• Philips X7-2 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• C5-2 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• L15-7IO TRANSDUCER Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X

  Orthofix U.S. LLC · Devices · 2025-11-03
  Class III
• Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

  Penner Patient Care, Inc. · Devices · 2025-08-13
  Class III
• Philips C9-4 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• X7-2t Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Philips L12-5 Ultrasound Transducer

  Philips Ultrasound, Inc · Devices · 2025-09-05
  Class III
• L17-5 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33

  Orthofix U.S. LLC · Devices · 2025-11-03
  Class III
• C10-3v Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• C9-5ec Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S8-3 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S12-4 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• S7-2t Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g T

  Home Health US, Incorporated · Devices · 2025-07-25
  Class III
• X3-1 Transducer Probe

  Philips Ultrasound, Inc · Devices · 2025-07-03
  Class III
• Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC

  Orthofix U.S. LLC · Devices · 2025-11-03
  Class III
• Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister ca

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-01-25
  Class III
• Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-07-02
  Class III
• Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427

  Padagis US LLC · Drugs · 2024-10-11
  Class III
• Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord

  Accord Healthcare, Inc. · Drugs · 2024-06-18
  Class III
• IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-10-29
  Class III
• Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-05-01
  Class III
• Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate,

  Bryant Ranch Prepack, Inc. · Drugs · 2024-05-10
  Class III
• Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactur

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-07-02
  Class III
• Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuti

  Contract Pharmaceuticals Limited Canada · Drugs · 2024-02-20
  Class III
• Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, U

  Bryant Ranch Prepack, Inc. · Drugs · 2024-05-10
  Class III
• Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Bru

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Drugs · 2024-11-05
  Class III
• Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic

  Washington Homeopathic Products, Inc. · Drugs · 2024-05-31
  Class III
• Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodar

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-07-02
  Class III
• Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46,

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HD

  Granules Consumer Health Inc. · Drugs · 2024-07-18
  Class III
• PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100

  Novel Laboratories, Inc. d.b.a Lupin Somerset · Drugs · 2024-07-02
  Class III
• Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-01-18
  Class III
• Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table

  GlaxoSmithKline LLC · Drugs · 2024-05-17
  Class III
• AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ,

  Rubicon Research Private Limited · Drugs · 2024-08-24
  Class III
• Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral C

  Elevate Oral Care · Drugs · 2024-08-20
  Class III
• Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Dist

  AvKARE · Drugs · 2024-12-18
  Class III
• Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LL

  Imprimis NJOF, LLC · Drugs · 2024-04-10
  Class III
• Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmed

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-05-16
  Class III
• Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceuti

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2024-04-22
  Class III
• Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5

  Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Drugs · 2024-04-09
  Class III
• Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, A

  X-Gen Pharmaceuticals Inc. · Drugs · 2024-04-02
  Class III
• Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59

  Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Drugs · 2024-04-09
  Class III
• Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydu

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-11-14
  Class III
• Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hik

  Hikma Injectables USA Inc · Drugs · 2024-04-30
  Class III
• Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (

  Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Drugs · 2024-04-09
  Class III
• Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-91

  Stason Pharmaceuticals, Inc. · Drugs · 2024-02-09
  Class III
• Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories I

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-11-22
  Class III
• Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd

  Rising Pharma Holding, Inc. · Drugs · 2024-06-24
  Class III
• Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP

  Bryant Ranch Prepack, Inc. · Drugs · 2024-05-10
  Class III
• Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ

  Rising Pharma Holding, Inc. · Drugs · 2024-05-16
  Class III
• Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL

  GLOBAL WIDGET LLC · Drugs · 2024-06-25
  Class III
• Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canad

  Contract Pharmaceuticals Limited Canada · Drugs · 2024-02-20
  Class III
• Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA I

  West-Ward Columbus Inc · Drugs · 2024-12-19
  Class III
• Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-01-18
  Class III
• Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W B

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, O

  Taro Pharmaceuticals U.S.A., Inc. · Drugs · 2024-08-07
  Class III
• Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 g

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2024-09-30
  Class III
• Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 3

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-07-02
  Class III
• Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 V

  Biocompatibles UK, Ltd. · Drugs · 2024-08-15
  Class III
• Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV

  Viatris Inc · Drugs · 2024-04-25
  Class III
• Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419

  GLOBAL WIDGET LLC · Drugs · 2024-06-25
  Class III
• Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, F

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for:

  Organon Llc · Drugs · 2024-05-28
  Class III
• Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fur

  Denison Pharmaceuticals, LLC · Drugs · 2024-09-25
  Class III
• Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US

  Akron Pharma, Inc. · Drugs · 2024-12-12
  Class III
• Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E.

  Eugia US LLC · Drugs · 2024-05-22
  Class III
• Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ

  Amneal Pharmaceuticals, LLC · Drugs · 2024-08-01
  Class III
• Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Driv

  Novitium Pharma LLC · Drugs · 2024-03-04
  Class III
• Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt

  Denison Pharmaceuticals, LLC · Drugs · 2024-09-25
  Class III
• HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: Americ

  Amerisource Health Services LLC · Drugs · 2024-02-01
  Class III
• Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-06-04
  Class III
• Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahme

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2024-05-16
  Class III
• Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Dri

  Novitium Pharma LLC · Drugs · 2024-03-25
  Class III
• Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton con

  Teva Pharmaceuticals USA, Inc · Drugs · 2024-01-25
  Class III
• Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP e

  Bryant Ranch Prepack, Inc. · Drugs · 2024-05-10
  Class III
• Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Lab

  Dr. Reddy's Laboratories, Inc. · Drugs · 2024-06-26
  Class III
• NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Ther

  Esperion · Drugs · 2024-03-27
  Class III
• Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for:

  Organon Llc · Drugs · 2024-05-28
  Class III
• Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL

  GLOBAL WIDGET LLC · Drugs · 2024-06-25
  Class III
• Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somer

  SOMERSET THERAPEUTICS LLC · Drugs · 2024-12-16
  Class III
• Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, L

  Acella Pharmaceuticals, LLC · Drugs · 2024-04-24
  Class III
• Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5

  Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Drugs · 2024-04-09
  Class III
• Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx

  X-Gen Pharmaceuticals Inc. · Drugs · 2024-04-02
  Class III
• Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for:

  Organon Llc · Drugs · 2024-05-28
  Class III
• Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 3

  GLOBAL WIDGET LLC · Drugs · 2024-06-25
  Class III
• SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12

  Neilmed Pharmaceuticals Inc · Drugs · 2024-06-24
  Class III
• Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burba

  Bryant Ranch Prepack, Inc. · Drugs · 2024-05-10
  Class III
• Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by

  AvKARE · Drugs · 2024-12-18
  Class III
• Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo

  DRG International, Inc. · Devices · 2024-07-05
  Class III
• 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O

  DRG International, Inc. · Devices · 2024-09-13
  Class III
• Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and

  Randox Laboratories Ltd. · Devices · 2024-04-05
  Class III
• Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective feature

  Trackx Technology Inc · Devices · 2024-09-03
  Class III
• HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

  O&M HALYARD, INC. · Devices · 2024-02-20
  Class III
• The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in

  Qualigen Inc · Devices · 2024-12-03
  Class III
• TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental

  STRATASYS LTD · Devices · 2024-01-19
  Class III
• Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic

  Beckman Coulter, Inc. · Devices · 2024-07-16
  Class III
• NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonS

  Avanos Medical, Inc. · Devices · 2024-03-04
  Class III
• VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-05-14
  Class III
• NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonS

  Avanos Medical, Inc. · Devices · 2024-03-04
  Class III
• eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

  T.G. Eakin Limited · Devices · 2024-08-08
  Class III
• Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is i

  Zyno Medical LLC · Devices · 2024-09-30
  Class III
• Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the p

  Abbott Medical · Devices · 2024-10-01
  Class III
• TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental

  STRATASYS LTD · Devices · 2024-01-19
  Class III
• Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

  Abbott Molecular, Inc. · Devices · 2024-02-01
  Class III
• In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319

  Abbott Molecular, Inc. · Devices · 2024-02-01
  Class III
• BiomarC EX Fiducial Marker System, Catalog Number 040165

  Carbon Medical Technologies, Inc. · Devices · 2024-07-26
  Class III
• TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental a

  STRATASYS LTD · Devices · 2024-01-19
  Class III
• iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochle

  Iotamotion Inc · Devices · 2024-09-12
  Class III
• VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calib

  Ortho-Clinical Diagnostics, Inc. · Devices · 2024-05-08
  Class III
• In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT

  Abbott Molecular, Inc. · Devices · 2024-02-01
  Class III
• Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capa

  Abbott Medical · Devices · 2024-10-01
  Class III
• Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in man

  Remote Diagnostic Technologies Ltd. · Devices · 2024-10-28
  Class III
• TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental

  STRATASYS LTD · Devices · 2024-01-19
  Class III
• NavaClick Syringe and Needle, Model Number LIN02

  LINEAGE BIOMEDICAL, INC · Devices · 2024-07-12
  Class III
• TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental a

  STRATASYS LTD · Devices · 2024-01-19
  Class III
• a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;

  Alcon Research LLC · Devices · 2024-10-15
  Class III
• NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSt

  Avanos Medical, Inc. · Devices · 2024-03-04
  Class III
• Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Ph

  Teva Pharmaceuticals USA Inc · Drugs · 2023-03-27
  Class III
• VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compar

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-10-04
  Class III
• Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge

  Sciegen Pharmaceuticals Inc · Drugs · 2023-02-17
  Class III
• Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute

  Teva Pharmaceuticals USA Inc · Drugs · 2023-04-27
  Class III
• Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 061

  NCS Healthcare of Kentucky Inc · Drugs · 2023-10-27
  Class III
• VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-10-04
  Class III
• Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single

  Caplin Steriles Limited · Drugs · 2023-08-14
  Class III
• Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufacture

  Focus Health Group Inc · Drugs · 2023-03-16
  Class III
• BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Man

  DuPont Nutrition USA, Inc · Drugs · 2023-02-01
  Class III
• FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPha

  OurPharma LLC · Drugs · 2023-01-13
  Class III
• Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Val

  Siegfried Barbera, SL · Drugs · 2023-11-20
  Class III
• Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, F

  VistaPharm LLC · Drugs · 2023-10-26
  Class III
• Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Su

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-07-18
  Class III
• Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 167

  Zydus Pharmaceuticals (USA) Inc · Drugs · 2023-02-24
  Class III
• ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters

  GlaxoSmithKline LLC · Drugs · 2023-12-12
  Class III
• Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti

  Lupin Pharmaceuticals Inc. · Drugs · 2023-06-27
  Class III
• Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenma

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-10-20
  Class III
• Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injecti

  Amneal Pharmaceuticals of New York, LLC · Drugs · 2023-05-08
  Class III
• Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC

  Lundbeck LLC · Drugs · 2023-08-17
  Class III
• Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc,

  Esperion · Drugs · 2023-08-16
  Class III
• Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu

  The Harvard Drug Group · Drugs · 2023-04-24
  Class III
• Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card

  NCS Healthcare of Kentucky Inc · Drugs · 2023-10-27
  Class III
• HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Healt

  Amerisource Health Services LLC · Drugs · 2023-09-01
  Class III
• Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals

  Amring Pharmaceuticals Inc · Drugs · 2023-06-12
  Class III
• Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk contain

  DuPont Nutrition USA, Inc · Drugs · 2023-02-01
  Class III
• Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan

  Accord Healthcare, Inc. · Drugs · 2023-03-29
  Class III
• Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottl

  Fagron Compounding Services · Drugs · 2023-11-10
  Class III
• V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd.

  Grato Holdings, Inc. · Drugs · 2023-10-30
  Class III
• Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manu

  AVEVA Drug Delivery Systems, Inc. · Drugs · 2023-02-15
  Class III
• Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured

  DuPont Nutrition USA, Inc · Drugs · 2023-04-13
  Class III
• Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manu

  AVEVA Drug Delivery Systems, Inc. · Drugs · 2023-02-15
  Class III
• Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc.

  Taro Pharmaceuticals Inc. · Drugs · 2023-11-06
  Class III
• Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Onl

  Padagis US LLC · Drugs · 2023-02-21
  Class III
• Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceutica

  Teva Pharmaceuticals USA, Inc · Drugs · 2023-11-10
  Class III
• Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratorie

  Ascend Laboratories, LLC · Drugs · 2023-07-18
  Class III
• Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: Du

  DuPont Nutrition USA, Inc · Drugs · 2023-04-13
  Class III
• MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% -

  Imprimis NJOF, LLC · Drugs · 2023-09-20
  Class III
• Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch

  Bryant Ranch Prepack, Inc. · Drugs · 2023-04-20
  Class III
• Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, N

  AVKARE LLC · Drugs · 2023-06-13
  Class III
• Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-07-05
  Class III
• Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in ca

  RB Health (US) LLC · Drugs · 2023-08-29
  Class III
• PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campb

  Vivus, Inc. · Drugs · 2023-06-23
  Class III
• Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured

  DuPont Nutrition USA, Inc · Drugs · 2023-04-13
  Class III
• Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-c

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-10-23
  Class III
• Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk contain

  DuPont Nutrition USA, Inc · Drugs · 2023-02-01
  Class III
• Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharm

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-10-04
  Class III
• buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-11-22
  Class III
• Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 6

  AbbVie Inc. · Drugs · 2023-10-17
  Class III
• Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distrib

  Akorn, Inc. · Drugs · 2023-01-30
  Class III
• SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menl

  Intersect ENT, Inc. · Drugs · 2023-01-04
  Class III
• Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar

  Lupin Pharmaceuticals Inc. · Drugs · 2023-01-20
  Class III
• Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding

  Denver Solutions, LLC DBA Leiters Health · Drugs · 2023-10-04
  Class III
• LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL

  Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop · Drugs · 2023-11-09
  Class III
• Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn

  Azurity Pharmaceuticals, Inc. · Drugs · 2023-12-08
  Class III
• GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-

  HF Acquisition Co LLC · Drugs · 2023-06-06
  Class III
• Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcar

  Baxter Healthcare Corporation · Drugs · 2023-08-14
  Class III
• Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute

  Teva Pharmaceuticals USA Inc · Drugs · 2023-04-27
  Class III
• Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only,

  SCA Pharmaceuticals · Drugs · 2023-02-24
  Class III
• 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND

  B. Braun Medical Inc. · Drugs · 2023-08-02
  Class III
• Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted befo

  Tolmar, Inc. · Drugs · 2023-09-12
  Class III
• Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for

  VistaPharm LLC · Drugs · 2023-10-17
  Class III
• Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute

  Teva Pharmaceuticals USA Inc · Drugs · 2023-04-27
  Class III
• Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk containe

  DuPont Nutrition USA, Inc · Drugs · 2023-02-01
  Class III
• Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured

  Glenmark Pharmaceuticals Inc., USA · Drugs · 2023-08-14
  Class III
• Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analg

  Advantice Health, Llc · Drugs · 2023-02-02
  Class III
• Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate

  Vi-Jon, LLC · Drugs · 2023-09-05
  Class III
• Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited,

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-03-09
  Class III
• Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceutical

  West-Ward Columbus Inc · Drugs · 2023-09-22
  Class III
• Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0

  MACLEODS PHARMA USA, INC · Drugs · 2023-01-05
  Class III
• Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American He

  Amerisource Health Services LLC · Drugs · 2023-12-26
  Class III
• Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited

  Contract Pharmaceuticals Limited Canada · Drugs · 2023-08-23
  Class III
• Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in indiv

  Pine Pharmaceuticals, LLC · Drugs · 2023-03-27
  Class III
• Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-09-07
  Class III
• Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc.

  Zyla Life Sciences US Inc. · Drugs · 2023-10-20
  Class III
• Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufac

  Edenbridge Pharmaceuticals, LLC · Drugs · 2023-10-20
  Class III
• PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacture

  Advanced Accelerator Applications USA, Inc. · Drugs · 2023-08-07
  Class III
• Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor,

  Aurolife Pharma, LLC · Drugs · 2023-05-18
  Class III
• Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute

  Teva Pharmaceuticals USA Inc · Drugs · 2023-04-27
  Class III
• Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ

  ALEMBIC PHARMACEUTICALS, INC. · Drugs · 2023-07-27
  Class III
• Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions,

  New England Life Care, Inc. dba Advanced Compounding Solutions · Drugs · 2023-05-22
  Class III
• Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute

  Teva Pharmaceuticals USA Inc · Drugs · 2023-04-27
  Class III
• Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured

  DuPont Nutrition USA, Inc · Drugs · 2023-04-13
  Class III
• MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned su

  Pfizer Inc. · Drugs · 2023-03-08
  Class III
• Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-

  Imprimis NJOF, LLC · Drugs · 2023-10-03
  Class III
• Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West,

  Imprimis NJOF, LLC · Drugs · 2023-08-10
  Class III
• Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packag

  SUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2023-03-29
  Class III
• DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-282

  Akron Pharma, Inc. · Drugs · 2023-02-17
  Class III
• Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT

  SCA Pharmaceuticals · Drugs · 2023-04-10
  Class III
• Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

  SUREPULSE MEDICAL LTD · Devices · 2023-01-20
  Class III
• VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the

  Ortho-Clinical Diagnostics, Inc. · Devices · 2023-05-18
  Class III
• Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

  SUREPULSE MEDICAL LTD · Devices · 2023-01-20
  Class III
• Alinity i Anti-TPO Reagent Kit, List Number 09P3521

  Abbott Ireland Limited · Devices · 2023-04-24
  Class III
• Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and rep

  Randox Laboratories Ltd. · Devices · 2023-05-04
  Class III
• PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue

  Preat Corp · Devices · 2023-02-01
  Class III
• Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

  Aizu Olympus Co., Ltd. · Devices · 2023-09-25
  Class III
• Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

  AGILENT TECHNOLOGIES INC./US · Devices · 2023-02-17
  Class III
• ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as

  Olympus Corporation of the Americas · Devices · 2023-03-31
  Class III
• FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code

  Owens & Minor Distribution, Inc. · Devices · 2023-01-03
  Class III
• To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural le

  Olympus Corporation of the Americas · Devices · 2023-03-31
  Class III
• Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accura

  Randox Laboratories Ltd. · Devices · 2023-05-04
  Class III
• Navik 3D v2, REF NAVIK3D, 3D Mapping System

  APN Health LLC · Devices · 2023-11-07
  Class III
• RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to m

  Mechatronics USA · Devices · 2023-04-14
  Class III
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

  Datascope Corp. · Devices · 2023-05-04
  Class III
• Achieva 3.0T, Model No. 781177

  Philips North America · Devices · 2023-12-29
  Class III
• ZVU Functional GI Software, REF: ZVU-3

  Diversatek Healthcare · Devices · 2023-07-25
  Class III
• SmartPath to dStream for 1.5T, Model No. 781260, 782112

  Philips North America · Devices · 2023-12-29
  Class III
• RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor t

  Mechatronics USA · Devices · 2023-04-14
  Class III
• Intera 1.5T, Model No. 781195

  Philips North America · Devices · 2023-12-29
  Class III
• Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

  SUREPULSE MEDICAL LTD · Devices · 2023-01-20
  Class III
• Achieva 1.5T, Model No. 781178, 781196, 781296

  Philips North America · Devices · 2023-12-29
  Class III
• Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

  Fresenius Medical Care Holdings, Inc. · Devices · 2023-10-24
  Class III
• CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through t

  Maquet Medical Systems USA · Devices · 2023-11-14
  Class III
• abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Bre

  S & MOHR AMERICA, S.A. DE C.V. · Devices · 2023-01-05
  Class III
• Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

  SUREPULSE MEDICAL LTD · Devices · 2023-01-20
  Class III
• NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and o

  NeuMoDx Molecular Inc · Devices · 2023-05-15
  Class III
• Achieva 1.5T Conversion, Model No. 781283

  Philips North America · Devices · 2023-12-29
  Class III
• Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

  SUREPULSE MEDICAL LTD · Devices · 2023-01-20
  Class III
• Ingenia Ambition X, Model No. 782109

  Philips North America · Devices · 2023-12-29
  Class III
• KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

  Microbiologics Inc · Devices · 2023-08-14
  Class III
• Total Knee Pack, REF CETJ130, medical convenience kits

  American Contract Systems, Inc. · Devices · 2023-04-17
  Class III
• SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to C

  Randox Laboratories Ltd. · Devices · 2023-11-06
  Class III