BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    KM-KAL L3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518822·CODMAN® Atrial Catheter

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780541714·CODMAN® Atrial Catheter

    CODMAN MEDOS

    FDA UDI
    Cerenovus, Inc.·10886704041269·CODMAN MEDOS Atrial Catheter

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972359·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972366·

    Digital Thermometer (Model QT001)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODEL 9600, AVANT PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAKIM ATRIAL CATH, 46CM

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·October 4, 2024

    7900

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

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·November 7, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 6, 2015

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    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