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

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    MONOJET 520 20CC SYRINGES W/NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788220290·7mm Lumbar Shaver Distractor

    FAC-4 - Class B 21 - 4 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620299·FAC-4 - Class B 21 - 4 Shelf Cabinet

    QUINCKE SPINAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OBJECTIVE REFRACTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRIAL IMPLANT LARGE DEEP-5MM

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HWT·May 20, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 9, 2012

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE·Product code DSQ·June 5, 2015

    DURALOC CONST LINER 54X32

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWZ·February 18, 2025

    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