BEUDAMED
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    HESUNG'S BLOOD DONOR SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VM PACS WITH VM MEDICAL WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIQUICHEK WHOLE BLOOD VOLATILES CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    FOOTSWITCH 1895420 XPS MULTIFUNCTION

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code ERL·November 21, 2012

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 30, 2014

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIKE SE & CO. KG·Product code NVZ·September 17, 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

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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