BEUDAMED
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    OLYMPUS DIRECT BILIRUBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DONUT PC 9DX1.5(6/PK) W/SILVER CIDE NOW COMES IN YELLOW

    FDA UDI
    ALIMED, INC.·00733657238754·

    EXTEND TRACK UNIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 17, 2013

    I-STAT EG6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code JJE·November 22, 2010

    ENDOCLIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code FZP·July 3, 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