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

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    PARA CHECK (AKA EIGHT CHECK-C)

    FDA 510(k)
    FDA Class 2 ·Hematology

    CT Rembra RT; CT Areta RT; CT Rembra

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONMED LINVATEC INSTRUMENT STERILIZATION TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 6, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·November 30, 2012

    MICROPLEX COMPLEX DIAMETER

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·June 16, 2015

    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