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

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    HANDHELD PACEMAKER PROGRAMMER & SOFTWAR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Barrx RFA Self Sizing Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FPO·November 9, 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