BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GEM Premier 5000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Aluminum back folding wheelchair SYIV 100-LQXAL2482-407

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 12, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 23, 2013

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016