BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    GX-2000 STATIONARY X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    Medline-Microtek

    FDA UDI
    Microtek Medical LLC·00748426143108·Patient Drape, Eye / Ear Drape, 81 cm x 127 cm ...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196334·AK3 PS Femoral Trials Size 1 - 5 Right Pan

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195030·AK3 PS Femoral Trials Size 1 - 5 Right Pan Insert

    CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090

    FDA 510(k)
    FDA Class 2 ·Dental

    Leaf Photocoagulator

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SUPERLINE

    FDA Adverse Event
    Injury ·DENTIUM USA·Product code DZE·October 28, 2010

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014

    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