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

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    EV MONOCANALICULAR STENT (TM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    K883239

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009

    CAPD DISP DISCONNECT, UV FLASH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008

    MEUROMETRICS MONITOR

    FDA 510(k)
    FDA Class 1 ·Neurology

    THE PFT FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 23, 2014

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MWS·October 20, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 21, 2012

    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