BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ivWatch Model 400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STOCKERT SCP RHYTHM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 1, 2014

    E SERIES DEDFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 22, 2012

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 18, 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