BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    CHEMISTRY CONSOLE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EXULT Knee Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VARI-ABLE APB (ADAPTABLE POSITIONING BASE)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 2, 2014

    TOTALCARE BARIATRIC PLUS

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 9, 2012

    FLOWIRE XT DOPPLER GUIDE WIRE

    FDA Adverse Event
    Malfunction ·VOLCANO CORPORATION·Product code DQX·August 31, 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