BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    RIWOLITH 2280

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEMO-CATH 10F, HEMO-CATH 12.5F

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Agilon Strip

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HIRES 90K IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·January 9, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 24, 2010

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    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