Data / Medical devices / Canada / Becton Dickinson Canada Inc.
Becton Dickinson Canada Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 8 510(k) clearances
Becton Dickinson Canada Inc. is registered with the FDA (registration 3045891669) in Mississauga Ontario, Canada. It lists 14 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045891669
- Address
- 2100 Derry Rd West Suite 100, Mississauga Ontario, Canada, L5N0B3
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Exporter to the US
- First device listed
- November 26, 2007
- Registered through
- 2026
- Brand names listed
- B-D GUARDIAN NESTABLE SHARPS COLLECTORS, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55, BD Sharps Collector, BD Sharps Collectors, Hemosphere, Hemosphere Alta and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 23, 2025 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | DQK | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| December 9, 2024 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | DYG | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| May 14, 2014 | K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 27, 2013 | K130197 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 9, 2013 | K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 28, 1994 | K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| November 7, 1994 | K943134 | B-D GUARDIAN NESTABLE SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| October 14, 1994 | K943575 | B-D GUARDIAN NESTABLE SHARPS COLLECTORS | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
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Updated July 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.