BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    S.I.N. Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Straight Driver Shaft

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215067847·

    INNOVA EPVISION 2.0, INNOVA EPVISION 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Widex

    FDA UDI
    Widex A/S·05706069691368·Widex BEYOND B-F2 (Summer gold ) 330, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069827552·WIDEX EVOKE EBB3D (Summer gold ) 330, Telecoil,...

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    ACCU-CHEK ® TENDER INFUSION SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 9, 2013

    PARADIGEM REAL-TIME INSULIN INFUSION PUMP

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

    COLLEAGUE

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

    SOFTCLIX ® PLUS GT LANCET DEVICE

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

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code LZG·August 28, 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