BEUDAMED
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    RECOVER INFANT HEEL WARMER (5100)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SCREW-IN GUIDE TO GUIDE THREADS

    FDA Adverse Event
    Injury ·STRYKER·Product code HWC·December 28, 2017

    CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RESIDENT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 22, 2010

    NA

    FDA Adverse Event
    Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NUJ·February 15, 2013

    ROTALINK? BURR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·July 29, 2014

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017