BEUDAMED
    17 results · 35ms · Sources: EU EUDAMED, US FDA

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    CHLAMYDELISA TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MEDCOMP FEMORAL VEIN CATHETER

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

    HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M2A-MAGNUM MODULAR HEAD 52MM

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

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 28, 2012

    SIG FEM ADPT TORQUE WRENCH

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·June 5, 2015

    TPRLC 133 T1 PPS SO 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 10, 2025

    TPRLC 133 T1 PPS HO 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 10, 2025

    TPRLC 133 MP TYPE1 PPS SO 17.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·March 10, 2025

    TPRLC 133 T1 PPS HO 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 10, 2025

    TPRLC 133 MP TYPE1 PPS HO 15.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·March 10, 2025

    TPRLC 133 MP TYPE1 PPS HO 17.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·March 10, 2025

    TPRLC 133 MP T1 PPS SO 7X99MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·March 10, 2025

    TPRLC 133 T1 PPS SO 17X154MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 10, 2025

    TPRLC XR MP T1 PPS 17X119MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·March 10, 2025

    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