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

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    MANIFOLD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEWCHILL(TM) CARDIAC INSULATOR

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    HYGEIA EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2014

    MENISCAL CINCH, CURVED TIP

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code GAT·November 11, 2010

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·December 28, 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