Data / Medical devices / Canada / Profound Medical Inc.
Profound Medical Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 5 510(k) clearances
Profound Medical Inc. is registered with the FDA (registration 3012604011) in Mississauga Ontario, Canada. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012604011
- Address
- 2400 Skymark Avenue, Unit 6, Mississauga Ontario, Canada, L4W 5K5
- Owner or operator
- Profound Medical Inc. (10061262)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 3, 2019
- Registered through
- 2026
- Brand names listed
- Sonalleve MR-HIFU, TULSA-PRO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Intensity Ultrasound System For Prostate Tissue Ablation | PLP | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| QND | QND | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 9, 2024 | K240296 | Tulsa Pro System (Pad-105) | PLP | Substantially Equivalent | Profound Medical, Inc. | accessdata.fda.gov |
| September 20, 2023 | K230692 | TULSA-PRO System | PLP | Substantially Equivalent | Profound Medical, Inc. | accessdata.fda.gov |
| September 6, 2022 | K211858 | TULSA-PRO System | PLP | Substantially Equivalent | Profound Medical, Inc. | accessdata.fda.gov |
| September 16, 2020 | K202286 | Tulsa-Pro System | PLP | Substantially Equivalent | Profound Medical, Inc. | accessdata.fda.gov |
| August 15, 2019 | K191200 | TULSA-PRO System | PLP | Substantially Equivalent | Profound Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 9, 2024. 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.