BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SNOREMASTER

    FDA 510(k)
    FDA Class 2 ·Dental

    P.F.C. SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295230953·P.F.C. SIGMA RP-F TIBIAL INSERT TRIAL SIZE 2.5 ...

    InSet Reverse Total Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·November 16, 2007

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 10, 2011

    LANCET DEVICE SNSRTR CMFRT EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 23, 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