BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    PHADEBACT ETEC-LT TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DIGITILT LS-30 REMOTE CONTROL

    FDA 510(k)
    FDA Class 2 ·Radiology

    INRA MENEZO B2 MEDIA

    FDA 510(k)
    FDA Class 1 ·Hematology

    HOUSE/3M SINGLE CHANNEL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD .·Product code MCM·June 16, 2014

    HALO360 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL, INC.·Product code GEI·October 15, 2010

    IMMULITE 2000 XPI

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·December 14, 2012

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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