BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    IL TEST(TM) BENZODIAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNCHRON (R) SYSTEMS CREATININE REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGX·July 2, 2011

    CR SPIRAL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QMS TM- PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·July 13, 2015

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2013

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HWC·July 4, 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

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021