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

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    CLOSED WOUND RESERVOIR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    9800

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

    AUTOTOME¿ RX 44

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·January 4, 2013

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS - (AORTIC)

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 11, 2010

    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