BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    DIGOXIN (FPIA) CALIBRATOR KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PEEK KNOTLESS ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TAURUS PEEK Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 11, 2019

    CONTOUR CUTTER STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 12, 2014

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2012

    PLUM XL

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·September 24, 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