BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    KERR CAVALITE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEN TEK COMFORT FIT NIGHTGUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    STAR 65

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    POSEY BED CANOPY SYSTEM

    FDA Adverse Event
    Malfunction ·J. T. POSEY COMPANY·Product code FNL·October 12, 2010

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·December 13, 2012

    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