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

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    IDL-LYSING REAGENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM

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

    GMK EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    ZELTIQ EZ APP 8.0

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS,INC.·Product code OOK·November 12, 2012

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·September 21, 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