BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    M-TWO INSTRUMENT

    FDA UDI
    SWEDEN & MARTINA SPA·D7700831663·M-TWO INSTRUMENT 30/.06 25 MM, 6 PCS

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361036098·SCREW, SOLID WALL, CANNULATED, Ø8MM X 65MM, SAC...

    Spreader L 11mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215067809·

    WAKO NEFA LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 31, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·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