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

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    SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C900 X-RAY FILM PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEREOTACTIC IRRADIATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·February 22, 2013

    WELLFLEX BILIARY RX STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·January 31, 2011

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FSA·August 4, 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