BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    IP-758 BURN WOUND DRESSING

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

    MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDPOR QUAD MOTILITY IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNIVERS II HUMERAL STEM 10MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KWS·October 14, 2011

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 23, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 3, 2007

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 31, 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