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

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    ACTIVITY CHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PROTECH DENT

    FDA 510(k)
    FDA Unclassified ·Unknown

    SIB CATHETER, MODEL 61-7005

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COMPLETE RADIOLUCENT INSERTION HANDLE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·March 4, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 17, 2013

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    28MM DIA COCR MOD HD -3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 9, 2014

    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