BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

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

    EzDent-i / E2 / Prora View

    FDA 510(k)
    FDA Class 2 ·Radiology

    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 13, 2014

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 12, 2010

    SONICARE

    FDA Adverse Event
    Other ·PHILIPS ORAL HEALTHCARE·Product code JEQ·December 5, 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