BEUDAMED
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    KENDALL SHERIDAN CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DA VINCI FEMTOSECOND SURGICAL LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Concerto Versa™ Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·February 9, 2013

    TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·January 5, 2011

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 23, 2014

    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