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

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    CEP 8 SPECTRUMORANGE DNA PROBE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Phantom® Hindfoot TTC/TC Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ebb Complete Tamponade System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code DXY·February 9, 2013

    MEDTRONIC ANEURX STENT

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MIH·January 4, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2014

    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