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

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    MR7000 WITH TIME MANAGER SOFTWARE (TMS)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 8, 2024

    ANTACHE ANTI-HEADACHE DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    HTR POLYMER, HTR-MX

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

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·December 21, 2010

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 15, 2014

    AUTOPULSE TRAINING LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·December 21, 2012

    Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016