BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    STarFix Designer Software C0265

    FDA 510(k)
    FDA Class 2 ·Neurology

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139232527·Patella Drill Guide Offset Dome Sz 1 & 2

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573021208·INTRG WHISP ROTH ANT 0T0A 022 LO

    PEN NDL 32GA 4MM 100 BX 1200 CA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 3, 2021

    ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EARPROBE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD ULTRA-FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 7, 2021

    ANGIOSCULPT

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC.·Product code DQY·June 26, 2013

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 12, 2008

    DRIVER RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MAF·August 26, 2011

    BD ULTRA-FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 10, 2021

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025