BEUDAMED
    3 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·May 20, 2020

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020