BEUDAMED
    7 results · 33ms · Sources: EU EUDAMED, US FDA

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    CAVIT-LC

    FDA 510(k)
    FDA Class 2 ·Dental

    Neuro Assessment System NAS-1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES .·Product code LZG·April 28, 2014

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·February 21, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 28, 2011

    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