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

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    SHEET WADDING CAST PADDING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PRESIDENT The Original

    FDA 510(k)
    FDA Class 2 ·Dental

    STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 20, 2014

    GEBAUER'S ETHYL CHLORIDE

    FDA Adverse Event
    Injury ·GEBAUER CO.·Product code MLY·October 31, 2012

    TRACER HYBRID WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KOG·August 25, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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