BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Cefaly Dual

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707001423·FIXING RINGS FIRST CLASS .

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180533932·LIF Curette, Pull, Smooth, Size 3

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position

    OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    I-FUSE HAMMER TOE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 30, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·August 25, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·February 3, 2021

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code LQR·January 8, 2025

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code LQR·February 10, 2022

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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