BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    NEPHELRATE ANTIPERUMS LGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    HEM-9000AI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIMETICAP

    FDA 510(k)
    FDA Class 2 ·Dental

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·April 30, 2014

    CASHMERE 14 - PLATINUM MICROCOIL

    FDA Adverse Event
    Injury ·MICRUS ENDOVASCULAR, LLC·Product code HCG·October 11, 2012

    PATCH

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NHW·August 3, 2010

    Assurity MRI Model Numbers: PM1272, PM2272 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