BEUDAMED
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    TEMP. CARDIAC PACING WIRE TME 60/61/65

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAYSCAN A-EXPERT 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    HL168R

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·May 27, 2014

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012

    HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·September 12, 2007

    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