Medical Device Manufacturer · CA , Mississauga

Profound Medical, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2019

Total

Cleared

Denied

Profound Medical, Inc. has 5 FDA 510(k) cleared medical devices. Based in Mississauga, CA.

Latest FDA clearance: May 2024. Active since 2019. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Profound Medical, Inc. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov.

Profound Medical, Inc. is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Profound Medical, Inc.

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 10, 2026