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

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    ACU-SLIDE-TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209117154·KIT, CUSTOM KOC; This kit contains item(s) lab...

    Fusion Compact Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYS CORP·Product code GEI·April 3, 2014

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·March 19, 2009

    RSP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·September 30, 2010

    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 12, 2020