BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    QUANTITOPE 125I-FOLATE RADIOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MANDREL GUIDEWIRES OR M-WIRE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    JOULE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014

    PUNCTUA

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

    LIFECARE INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·HOSPIRA INC·Product code MEA·July 27, 2010

    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