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

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    BIFURCATED Y-EXTENSION

    FDA 510(k)
    FDA Class 2 ·Neurology

    GAUZE SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Apollo Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code NVY·February 9, 2013

    PULSAR MAX

    FDA Adverse Event
    Injury ·GUIDANT CLONMEL IRELAND·Product code NVZ·January 10, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 23, 2014

    THERMA CARE

    FDA Adverse Event
    Injury ·PROCTER & GAMBLE PAPER PRODUCT CO·Product code IMD·March 6, 2002

    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