BEUDAMED
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    Carnation series Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113691·CYSTOTOME FORMED 25GA

    Spreader L 13mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215067816·

    CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM SPINE SPINOUS PROCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    CAPSUREFIX NOVUS

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

    RETAINER BRITE

    FDA Adverse Event
    Other ·TOWER LABORATORIES LTD.·Product code EFT·July 11, 2013

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·January 31, 2024

    MAZOR X SYSTEM

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

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·October 30, 2024

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025