Data / Medical devices / Canada / Swift Medical
Swift Medical: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Swift Medical is registered with the FDA (registration 3001744314) in Toronto Ontario, Canada. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001744314
- Address
- 1 King Street West Suite 4800 - 355, Toronto Ontario, Canada, M5H 1A1
- Owner or operator
- Swift Medical (10051277)
- Roles
- Manufacturer
- First device listed
- February 25, 2016
- Registered through
- 2026
- Brand names listed
- HealX, PointClickCare Skin and Wound, Swift Ray 1, Swift Skin and Wound, Swift Skin and Wound 2, Swift Vision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Autofluorescence Imaging Adjunct Tool For Wounds | QJF | 2 | Manufacturer | accessdata.fda.gov |
| Tape, Camera, Surgical | FXN | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| February 24, 2026 | K251678 | Swift Ray 1 | QJF | Substantially Equivalent | Swift Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape, Camera, Surgical
- All makers of Autofluorescence Imaging Adjunct Tool For Wounds
- All makers of Tape, Measuring, Rulers And Calipers
Updated February 24, 2026. 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.