BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    CTS-3060 AUTOMATED SEMEN ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    GLUCOSE REAGENT(UV-HEXOKINASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LDH REAGENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP·Product code MKJ·November 6, 2012

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 11, 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