BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    PRESSURE MONITORING KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIODERM SCIENCES WOUND CREAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    CardiacLinx

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 1, 2014

    X SERIES

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

    STARCLOSE SE VASCULAR CLOSURE 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