BEUDAMED
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    SIGMA PROCED. 245 ALKALINE PHOSPHATASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

    FDA 510(k)
    FDA Unclassified ·Unknown

    INTEGRATED PATIENT MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 30, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·November 21, 2012

    ACAT 1 IAB PUMP ASSEMBLY

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·August 31, 2010

    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