BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SAS QUANT HCG SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CRI CYNOSAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·February 5, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 3, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 18, 2014

    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·September 21, 2016