BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODEL 6500 MERCURY ARC LIGHT SOURCE

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

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707035886·WEB I MOL BANDS G8421-16+G2820-00 LR 8

    FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)

    FDA 510(k)
    FDA Unclassified ·Unknown

    GEMSTAR 7 SP NEW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 15, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    LRG TAP PRI MOD NCK 8 DEG 30MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code LZO·December 27, 2012

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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