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

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    DD URETERAL STENT, INTEGRAL STENT

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

    NuVasive Reline System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYSTIQUE MB CERAMIC BRACKETS

    FDA 510(k)
    FDA Class 2 ·Dental

    UNKNOWN DEPUY TIBIAL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·February 28, 2013

    PLM A+ SPANISH 110V

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 2, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 9, 2011

    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