BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ULTRASONIC TIPS WITH DIAMOND COATING

    FDA 510(k)
    FDA Class 2 ·Dental

    MERIDIAN CRANIAL PERFORATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    HAKIM IN LINE PROGRAMMABLE VALVE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC/ MEDOS S.A.·Product code JXG·November 5, 2008

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·August 17, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 11, 2013

    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