BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SHIGELLA I.D.

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UROPLASTY RIGID ENDOSCPIC NEEDLES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AART PECTORALIS IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014

    TOTALCARE BED

    FDA Adverse Event
    Injury ·HILL-ROM, INC.·Product code FNL·October 12, 2012

    I-STAT 1 ANALYZER - IMMUNO READY

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code JJE·August 26, 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