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

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    COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALIF

    FDA UDI
    Nuvasive, Inc.·00887517973030·ALIF Blade, 180mm Wide

    ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYVA(R) ETS(R) PLUS SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 5, 2015

    PROMOTE RF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·February 21, 2013

    HARMONIC CURVED BLADE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 1, 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