BEUDAMED
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    ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMARTCHECK INR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Otowave 302 Portable Tympanometer

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 16, 2014

    DURACON PLASTIC PATELLA MED1

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·October 13, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

    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