BEUDAMED
    14 results · 36ms · Sources: EU EUDAMED, US FDA

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    Para-Fix External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spreader L 15mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215067823·

    VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MRNA APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCU-CHEK TENDERLINK INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE HEALTH SOLUTIONS INC.·Product code FPA·February 8, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 11, 2014

    SECURA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·August 31, 2011

    6.0MM TI CANNULATED MATRIX SCREW 40MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code NKB·July 16, 2013

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 19, 2020

    Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 19, 2020