BEUDAMED
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    HWA-TO ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 23, 2015

    MODIFIED Q50 MEDICAL TREADMILL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code LXH·September 28, 2015

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 21, 2015

    ISTENT TRABECULAR MICRO-BYPASS

    FDA Adverse Event
    Malfunction ·GLAUKOS CORP.·Product code OGO·May 28, 2014

    MNH

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code MNI·February 13, 2013

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MIH·January 10, 2011

    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