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

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    STOCK #64091-PEDIATRIC OXYGEN MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377018335·RELINE-C Screw, 3.5x32mm FA PT

    Olea S.I.A. Neurovascular V1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    OCELOT PIXL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 8, 2012

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 2, 2010

    TRULIANT TIB IMP PS INSERT SZ 5 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 21, 2023

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

    FDA Enforcement
    Class II ·Ongoing·Microbiologics Inc·February 19, 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