BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    'EXMOOR' SINGLE USE SUCTION TUBE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Treace Medical Concepts (TMC) Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM

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

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 24, 2014

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 3, 2010

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·December 20, 2012

    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