BEUDAMED
    10 results · 16ms · Sources: EU EUDAMED, US FDA

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    ALPHA TRI-KART

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BANANA KNIFE - K841969-LABELING

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

    CAMELBACK HANDLE-K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    2.5MM & 4MM PROBE K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 30, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 21, 2012

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    FDA Adverse Event
    Malfunction ·ZIMMER·Product code JWH·August 31, 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