BEUDAMED
    2 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    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