Manufacturer Intelligence · Based on 53,571 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - France

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

French medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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174

Manufacturers

France

Country

France FDA 510(k) Overview

173

Manufacturers

431

Submissions

99%

Clearance rate

Leading France FDA 510(k) manufacturers include GE Medical Systems SCS, Newclip Technics, Medicrea International SA and 171 others.

French medical device manufacturers have submitted 431 FDA 510(k) notifications since 2018, with a 99.1% clearance rate across 173 manufacturers. France's medtech sector shows consistent FDA activity in cardiovascular, orthopedic and ophthalmic devices, supported by a strong regulatory affairs infrastructure for international market access.

Active in FDA 510(k) submissions since 2018. Many France manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) France Manufacturers

1–50 of 174

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	GE Medical Systems SCS Buc Cedex	25	100%	RA	FR
2	Newclip Technics Haute-Goulaine	16	100%	OR	FR
3	Medicrea International SA Neyron	11	100%	OR	FR
4	S.M.A.I.O Saint-Priest	10	100%	OR RA	FR
5	Biomerieux S.A. Craponne	9	100%	MI	FR
6	FH Industrie Quimper Finistere	9	100%	OR RA	FR
7	Quantel Medical Cournon D'Auvergne-Cedex	8	100%	OP RA	FR
8	HORIBA ABX SAS Montpellier Cedex 4	8	100%	CH HE IM	FR
9	Supersonic Imagine Aix-En-Provence Cedex	7	100%	RA	FR
10	Avicenna.Ai La Ciotat	7	100%	RA	FR
11	Mauna Kea Technologies Paris	6	100%	NE SU	FR
12	Biosphere Medical, S.A. Roissy-En-France	6	100%	CV NE	FR
13	Clariance, Sas Beaurains	6	100%	OR	FR
14	Sim&Cure Grabels	6	100%	CV NE	FR
15	Therapixel Valbonne	6	100%	RA	FR
16	Pixee Medical Besan?on	6	100%	OR RA	FR
17	Ecential Robotics Gieres	6	100%	OR RA	FR
18	Medtech S.A Montpellier	5	100%	NE OR	FR
19	Blue Ortho La Tronche	5	100%	OR	FR
20	Spinevision, S.A.S. Antony	5	100%	OR	FR
21	Volta Medical Marseille	5	100%	CV	FR
22	Sonio Paris	5	100%	RA	FR
23	Brightheart Paris	5	100%	RA	FR
24	Anthogyr Sallanches	4	100%	DE HO	FR
25	Trophy Marne La Vallee Cedex 2	4	100%	DE RA	FR
26	Fci (France Chirurgie Instrumentation) Sas Paris	4	100%	OP	FR
27	Moon Surgical Paris	4	100%	SU	FR
28	Sophysa Orsay	4	100%	NE	FR
29	Biocorp Production Issoire	4	100%	HO	FR
30	Therapanacea Sas Paris	4	100%	RA	FR
31	Medicrea International S.A.S. (Medtronic) Rillieux-La-Pape	4	100%	OR RA	FR
32	3-D Matrix Europe SAS Caluire Et Cuire	4	100%	GU SU	FR
33	Implanet Allee Francois Magendie	3	100%	OR	FR
34	Cousin Biotech Sas Wervicq-Sud	3	100%	OR	FR
35	Hemodia Sas Labege	3	100%	OR	FR
36	Novastep Saint Gregoire	3	100%	OR	FR
37	Phakos Montreuil	3	100%	OP	FR
38	Idmed Marseille	3	100%	AN	FR
39	Bioserenity Sas Paris	3	100%	CV NE	FR
40	Dosisoft Cachan	3	100%	RA	FR
41	Biom?rieux SA Marcy-L'?toile	3	100%	CH MI	FR
42	Therapanacea Paris	3	100%	RA	FR
43	Biotech Dental, Sas Salon De Provence	3	100%	DE HO	FR
44	Institut Georges Lopez Lissieu	3	100%	GU	FR
45	Stephanix La Ricamarie	3	100%	RA	FR
46	E-Scopics Aix-En-Provence	3	100%	RA	FR
47	Olea Medical S.A.S. La Ciotat	3	100%	RA	FR
48	X6 Innovations Paris	3	100%	GU OB	FR
49	Wandercraft SAS Paris	3	100%	NE	FR
50	Avatar Medical Paris	3	100%	RA	FR

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.