BEUDAMED
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    EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379·Product code JDI·July 15, 2015

    OT ULTRALINK METER

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

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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