Medical Device Manufacturer · CA , Mississauga

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

5 submissions · 5 cleared · Since 2019

Recent clearances: Tulsa Pro System (Pad-105), TULSA-PRO System, TULSA-PRO System

5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Profound Medical, Inc. Gastroenterology & Urology ✕

5 devices
1-5 of 5
Cleared May 09, 2024
Tulsa Pro System (Pad-105)
K240296 · PLP
Gastroenterology & Urology · 98d
Cleared Sep 20, 2023
TULSA-PRO System
K230692 · PLP
Gastroenterology & Urology · 191d
Cleared Sep 06, 2022
TULSA-PRO System
K211858 · PLP
Gastroenterology & Urology · 447d
Cleared Sep 16, 2020
Tulsa-Pro System
K202286 · PLP
Gastroenterology & Urology · 35d
Cleared CT Aug 15, 2019
TULSA-PRO System
K191200 · PLP
Gastroenterology & Urology · 101d
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