BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WOODLYN CLASSIC SLIT LAMP MODEL SMM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 9, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 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