BEUDAMED
    13 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    MEDEVICES ASPIRATION HOSE

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

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518518·CODMAN® HAKIM® Precision Valve Unitized

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534051·Precision Fixed Pressure Valve Cylindrical Valv...

    CODMAN HAKIM

    FDA UDI
    Cerenovus, Inc.·10886704041009·CODMAN HAKIM Precision Fixed Pressure Valve Cyl...

    VariAx

    FDA UDI
    Stryker GmbH·37613154496991·BONE SCREW, CROSS-PIN, SELF-TAPPING

    Ditron Dental

    FDA UDI
    DITRON DENTAL LTD·07290109283487·Ti-Base Hexagonal Engaged H0.6

    AIR BARRIER SYSTEM (ABS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODEL TDS-2450-2 MICROWAVE DIATHERMY SYS

    FDA 510(k)

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·February 5, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 7, 2012

    IMR ETLOGIX¿ MITRAL ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·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