BEUDAMED
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    IRRAflow Active Fluid Exchange System (AFES)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD BBL™ Sensi-Disc™ Cefixime 5 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902316641·BD BBL™ Sensi-Disc™ Cefixime 5 µg

    COPRA TEMP PMMA-DISK

    FDA 510(k)
    FDA Class 2 ·Dental

    ELEMENTS OBTURATION UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿

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

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 14, 2008

    ACCU-CHEK TENDER INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·July 22, 2011

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·July 17, 2013

    BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664

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

    Revogene, Catalog no. 610210. IVD test instrument

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