BEUDAMED
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    KOMET SURGICAL BUR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TLX

    FDA UDI
    Nuvasive, Inc.·00887517730442·TLX Implant, 8x13x26mm 15°

    16CH AI BREAST COILS 1.5 T AND 3 T

    FDA 510(k)
    FDA Class 2 ·Radiology

    Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014

    EVITA 4

    FDA Adverse Event
    Malfunction ·DRAGER MEDICAL GMBH·Product code CBK·October 14, 2010

    VITROS 5600 INTEGRATED SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·December 21, 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