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

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    NOVA 4 NA/K/C1/TCO2/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 16, 2014

    ASR ACETABULAR IMPLANT 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 15, 2013

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·December 6, 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