BEUDAMED
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    MEDCARE WOUND CLOSURE TRAY

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

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780535102·Programmable Valve Cylindrical valve with Uniti...

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519874·CODMAN® HAKIM® Programmable Valve with Unitized...

    CODMAN HAKIM RICKHAM

    FDA UDI
    Cerenovus, Inc.·10886704041894·CODMAN HAKIM Programmable Valve with Unitized R...

    K-ASSAY LP(A) CONTROLS

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIVASIGHT-DL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 21, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012

    ASM, FOOT SECTION W/ MOTOR PACKAGE

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·June 8, 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