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

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    OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NUTRIBAG MIXING CONTAINER -2000 ML

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DOUBLE-COAGULATION SWITCHPEN 757

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACCESS ACCUTNI+3 REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MMI·July 1, 2015

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 19, 2014

    GORE DUALMESH PLUS BIOMATERIAL

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code FTL·October 25, 2010

    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