BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SIERRA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EIDON FA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·July 16, 2007

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024