Profound Medical, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. Matched by name to PROF.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Tulsa Pro System (Pad-105)510(k)May 9, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 9, 2024
TULSA-PRO System510(k)Sep 20, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 20, 2023
TULSA-PRO System510(k)Sep 6, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2022