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

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    LINAC SCALPEL FLOORSTAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAMMOSPOT 3 AND MAMMOSPOT 8

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·February 15, 2013

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 22, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 29, 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