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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MUELLER HINTON AGARS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Deflectable Brush Biopsy Set

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

    PET-TV X-RAY IMAGE INTENSIFIER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 5, 2014

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·October 15, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 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