BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Andwin Scientific

    FDA UDI
    Andwin Scientific·00187207000146·PAPKIT, 6000 XSF, 1 Super Frosted Slide, Scrape...

    Hose, Set of 6 (Lumenair™)

    FDA UDI
    VASOMEDICAL, INC.·00817980021242·Hose, Set of 6 (Lumenair™)

    3DMetal Diaphyseal Femoral Cones

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Widex

    FDA UDI
    Widex A/S·05706069691924·Widex BEYOND B-F2 (Lime green ) 330, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069827576·WIDEX EVOKE EBB3D (Lime green ) 330, Telecoil, ...

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·November 6, 2014

    SPRINT FIDELIS

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

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

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

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 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