BEUDAMED
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    COBAS FLUORESCENCE POLARIZATION MODULE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EXPLORER TIP

    FDA 510(k)
    FDA Class 1 ·Dental

    CARDIAC OUTPUT SIGNAL ACQUISTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 2, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·November 23, 2012

    ACCU-CHEK ® INFORM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·September 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