BEUDAMED
    16 results · 74ms · Sources: EU EUDAMED, US FDA

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    G Surgical Marksman Spinal Deformity System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925019447·VERY SMALL MIDDLE EAR SURGERY SCISSORS, CURVED ...

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020171·INTRG WHISP-Z ROTH 1BIC -17T 0A 018 LO

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036035013·

    Spreader L 7mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215067786·

    ARCOS TROCHANTER BUTTON

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AeroEclipse* ONE BAN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    I-STAT

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 16, 2013

    MAZOR X SYSTEM

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

    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