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

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    AUTOSTIK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TSO3 OZONE STERILIZER, MODEL 125L

    FDA 510(k)
    FDA Class 2 ·General Hospital

    B&W DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 13, 2014

    D901: LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 30, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·June 3, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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