BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    ENDOSCOPIC ACCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Barrier Sleeves and Covers

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PINNACLE REV ACET CUP 62MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 3, 2015

    INVANCE MALE SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 8, 2013

    DECOMPRESSION TUBE SNAKE ARM

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code LXH·July 28, 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