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

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    Filters Regulation: Us FDA ×

    CONTOUR ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPULSE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IM-CHECK

    FDA 510(k)
    FDA Class 2 ·Immunology

    INJ. OPTIV DH, W/OEM

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM·Product code IZQ·December 2, 2019

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 2, 2014

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·November 8, 2012

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CIC·September 24, 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