BEUDAMED
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    Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

    FDA 510(k)
    FDA Class 2 ·Dental

    BD BBL Sensi-Disc Ampicillin 2 ug

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902312636·BD BBL™ Sensi-Disc™ Ampicillin 2 µg

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506058929·PRISM CERVICAL CURETTE 10" REVERSE ANGLED 4-0, ...

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573021499·INTRG WHISP MBT 1BIC -12T 0A 018 LO

    XPERGUIDE

    FDA 510(k)
    FDA Class 2 ·Radiology

    3M LIQUID BANDAGE, MODEL 120-LB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 25, 2011

    ORACLE SLIDE HAMMER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZY·July 17, 2013

    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·December 11, 2024

    BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·November 6, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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