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

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    EMIT N-ACETYLPROCAINAMIDE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NEO TSH-RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PINN MAR LIP LNR 28IDX48OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 30, 2014

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 10, 2012

    PS TIBIAL INSERT

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code JWH·July 28, 2010

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022