BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    STERILE FOLEY CATHETERIZATION KITS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821979·GENERAL SURGICAL KIT

    PASS OCT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMISSON STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    36MM COCR MOD HD -3MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 20, 2014

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 1, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 1, 2010

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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