Edap Technomed, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Edap Technomed, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Focal One®, FOCAL ONE
5
Total
5
Cleared
0
Denied
Edap Technomed, Inc. has 5 FDA 510(k) cleared medical devices. Based in Norcross, US.
Latest FDA clearance: Nov 2025. Active since 2001. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Edap Technomed, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Edap Technomed, Inc.
5 devices
Cleared
Nov 19, 2025
Focal One®
Gastroenterology & Urology
152d
Cleared
Jun 07, 2018
FOCAL ONE
Gastroenterology & Urology
272d
Cleared
Oct 03, 2017
Ablatherm Fusion
Gastroenterology & Urology
67d
Cleared
Nov 06, 2015
Ablatherm Integrated Imaging
Gastroenterology & Urology
22d
Cleared
Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
Gastroenterology & Urology
88d