BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ELECSYS PSA, MODEL # ELECSYS 1010

    FDA 510(k)
    FDA Class 2 ·Immunology

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012

    Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

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

    HANDCARE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HS III PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 22, 2013

    MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPINE LLC·Product code HTF·July 2, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 9, 2011

    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