BEUDAMED
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    MERIT MANIFOLD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLO TEM II (BLOOD/FLUID WARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pristine Scope

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

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·June 11, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·December 2, 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