BEUDAMED
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    ROCHE REAGENT FOR AMMONIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ALN OPTIONAL VANA CAVA FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AMS GREENLIGHT HPS FIBER

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·January 8, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 2, 2010

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·REPIRONICS CALIFORNIA INC·Product code MNT·July 3, 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