BEUDAMED
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    BIPOLAR PENCIL COAGULATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGISTAR, INC.

    FDA UDI
    SURGISTAR, INC.·00878799002884·

    Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFIED REGULAR DEODORANT MAXITHINS PADS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·February 14, 2013

    QUATTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·January 13, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·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