BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    EUROTROL GAS - ISE CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704286120·

    MENTOR HORIZON LOW VISION MAGNIFIER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    COAGULATION CONTROL CONTAINING HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·February 11, 2013

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·July 24, 2014

    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