BEUDAMED
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    PATHO DX LATEX AGGLUTINATION STREP A

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RSA-CMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Optima XR200amx, Optima XR220amx

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 1, 2014

    TOTALCARE BARIATRIC PLUS

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 9, 2012

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·September 16, 2010

    MENTOR TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 4, 2019

    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