BEUDAMED
    9 results · 39ms · Sources: EU EUDAMED, US FDA

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    ABDOMINAL SPATULA

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

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077793·CUP CURETTE UP #000 - SERRATED

    STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GILLETTE HEAT WRAP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 3, 2010

    RIATA ST PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·December 29, 2012

    PERFORMER INTRODUCER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·October 2, 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