BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOWNLEY TOTAL KNEE (TTK)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOVA TRANSFER SYSTEM, MODEL XXX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUMMIT POR TAPER SLEEVE SZ9 HI OFF

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWY·February 22, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 3, 2014

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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