Novatech SA is one of 271 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Novatech SA - FDA 510(k) Cleared Devices
Recent clearances: DUTAU-NOVATECH®, TRACHEOBRONXANE™ DUMON®, NOVATECH TALCAIR
5
Total
4
Cleared
0
Denied
Novatech SA has 4 FDA 510(k) cleared medical devices. Based in La Ciotat Cedex, FR.
Latest FDA clearance: Feb 2025. Active since 1997. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Novatech SA Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Boston Medical Products, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Novatech SA
5 devices
Cleared
Feb 06, 2025
DUTAU-NOVATECH®
Ear, Nose, Throat
184d
Cleared
Oct 29, 2024
TRACHEOBRONXANE™ DUMON®
Anesthesiology
29d
Cleared
Mar 13, 2017
NOVATECH TALCAIR
General & Plastic Surgery
68d
Cleared
Mar 31, 2016
NOVATECH TALCAIR
General & Plastic Surgery
269d
Cleared
Aug 21, 1997
ENDOXANE
General & Plastic Surgery
118d