BEUDAMED
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    PRECEDENT

    FDA 510(k)
    FDA Class 2 ·Dental

    TEC TRACTION MACHINE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BIOCLONES ELEGANCE FSH ELISA KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 27, 2014

    MINIARC SINGLE-INCISION SLING

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 28, 2013

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 24, 2010

    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