BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    ORTHOPEDIC FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268215661·CUSTOM SURGICAL KIT VEIN PACK

    PLANER BT37 INCUBATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INFINITI

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·January 15, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·November 6, 2012

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·August 27, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 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