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

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    H-H BURR HOLE CATHETER SUPPORT

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113157·PS Insert, Size 3 x 11mm

    Aquaflex

    FDA UDI
    PARKER LABORATORIES INC·00303410000036·Profound 3cm narrow gel pad

    Aquaflex

    FDA UDI
    PARKER LABORATORIES INC·00303410000029·Profound 3cm wide gel pad

    Aquaflex

    FDA UDI
    PARKER LABORATORIES INC·00303410000012·Profound 2cm wide gel pad

    CLEARVIEW WRIST FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cardiovascular Angiography System

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 31, 2012

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·June 5, 2015

    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