13 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
FDA Enforcement
Class I
·Ongoing·3M Company·September 24, 2025
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
FDA Enforcement
Class I
·Ongoing·Aesthetics Systems Usa Inc·October 13, 2021
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
FDA Enforcement
Class I
·Terminated·First Medical Source LLC·December 5, 2012
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
FDA Enforcement
Class I
·Ongoing·Insulet Corporation·April 22, 2026