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

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    DISPOSABLE DISPENSE MANIFOLD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788232180·DLIF Caddy 2, 55-60mm, 6 deg

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435061158·MCD Screw 2.3 x 18 mm cannulated M1 violet

    ILLICO FS FACET FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODIFICATION TO PLEXOLONG SETS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·February 8, 2019

    OPTETRAK FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 24, 2025

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 20, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·November 7, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 6, 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