Data / Medical devices / Canada / Focal Healthcare Inc.
Focal Healthcare Inc.: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Focal Healthcare Inc. is registered with the FDA (registration 3011853771) in Toronto Ontario, Canada. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 15, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011853771
- Address
- 10 Morrow Ave., Unit 101, Toronto Ontario, Canada, M6R2J1
- Owner or operator
- Focal Healthcare Inc. (10051236)
- Roles
- Manufacturer
- First device listed
- November 2, 2018
- Registered through
- 2026
- Brand names listed
- Fusion Bx 2, Fusion Stepper
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair And Table, Medical | KMN | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| June 15, 2018 | K181290 | Fusion Bx 2.0 | LLZ | Substantially Equivalent | Focal Healthcare, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 15, 2018. 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.