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

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    EKTACHEM CLINICAL CHEM. SLIDES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517375100·CoRoent Small Contoured, 6L Open

    Fresh Cells

    FDA UDI
    DIAGNOSTIC HYBRIDS, INC.·30014613334163·VERO 6 WELL PLATES, 6 W FILLED

    1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROMEDIC AUTOMATIC DILUTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 30, 2014

    TRIMA ACCEL

    FDA Adverse Event
    TERUMO BCT·Product code GKT·November 20, 2012

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·June 11, 2015

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017