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

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    SCISSORS, VARIOUS

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

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788224480·Cervical Trial +DS 9x14x12 Lordotic

    Partial Pelvis Replacement

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575200566·4 hole flanges,with caudal flange

    WATER PURIFICATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UNITY Sacroiliac Joint Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·May 20, 2014

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·June 6, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 26, 2010

    Assurity MRI Model Numbers: PM1272, PM2272 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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012