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

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    AMBER-CHEST

    FDA 510(k)
    FDA Class 2 ·Radiology

    WELLNESSPRO 2010

    FDA 510(k)
    FDA Class 2 ·Neurology

    Wrist Type Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 8, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 10, 2012

    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.

    FDA Recall
    Terminated ·Fujinon Inc·Product code FDS·July 31, 2013

    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