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

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    SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hair Regrowth Cap (Model: T-119-HRC)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HOFFMANN II ROD TO WIRE COUPLING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·February 9, 2013

    SYNCHRON® CX4 DELTA CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 8, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·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