BEUDAMED
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    COOK PACEMAKER 215 UNIPOLAR CARDIAC-

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HOMECHOICE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 30, 2014

    NATURAL-KNEE II STEMMED TIBIAL BASEPLATE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 14, 2012

    KAPPA 700 SR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·September 23, 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