BEUDAMED
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    RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984045·anteriors; shade A2; mould Q 45

    #504 MINI COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFIED POLYCHROME IV STAIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    PENUMBRA SYSTEM REPEFUSION CATHETER 5MAX

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 28, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 12, 2011

    1.85MM X 16MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013

    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