BEUDAMED
    9 results · 34ms · Sources: EU EUDAMED, US FDA

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    AUTOECHO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788229030·Kerrison, 40 deg Forward, 4mm Wide, 12" Long

    CHILLBUSTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tailored-H Cervical Stand Alone System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEICA M525 F20

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS ( SCHWEIZ) AG·Product code EPT·February 18, 2014

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·August 25, 2010

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    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