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

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    BILIRUBIN-SL (TOTAL) ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADJUSTABLE PEEP VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFE CORPORATION·Product code MVK·June 11, 2014

    TRIATHLON CR FEM COMP #3 L-CEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·February 22, 2013

    PRECISION OPTIUM EZ

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·January 31, 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