BEUDAMED
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    IREX 730 MECHANICAL SECTOR SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IQQA-CHEST SOFTWARE PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE PRO

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 2, 2014

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·November 21, 2012

    OCTRODE 3/4 PERCUTANEOUS LEADS

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 31, 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