BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    INSTANT REPLAY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MR-CT VVA

    FDA 510(k)
    FDA Class 2 ·Radiology

    MINI GAMMA CAMERA, MODEL MGC-500

    FDA 510(k)
    FDA Class 1 ·Radiology

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·May 30, 2014

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·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