BEUDAMED
    18 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

    FDA Enforcement
    Class II ·Ongoing·Oxoid Limited·February 12, 2025

    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

    BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿

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

    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿

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

    Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿

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

    Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿

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

    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿

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

    Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·August 5, 2015

    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

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

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016