BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PMP4 SPIROPRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARCHITECT TSH

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code JLW·February 8, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 6, 2011

    ZEPHYR XL DR

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 22, 2014

    ALP 501

    FDA Adverse Event
    Injury ·CURRIE MEDICAL SPECIALTIES·Product code JOW·September 1, 2012

    ALP 501

    FDA Adverse Event
    Injury ·CURRIE MEDICAL SPECIALTIES·Product code JOW·July 25, 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