72 results
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55ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD COR System Software. Model Number: 444829.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·July 30, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·March 12, 2025
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 2, 2024
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024