Manufacturer Intelligence · Based on 144,138 FDA 510(k) records · 84 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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271

Manufacturers

France

Country

France FDA 510(k) Overview

271

Manufacturers

978

Submissions

99%

Clearance rate

Leading France FDA 510(k) manufacturers include Bio-Rad Laboratories, GE Medical Systems SCS, Newclip Technics and 268 others.

French medical device manufacturers have submitted 978 FDA 510(k) notifications since 1990, with a 99.3% clearance rate across 271 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 1990. Many France manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) France Manufacturers

1–50 of 271

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Bio-Rad Laboratories Hauts-De-Seine	46	98%	CH HE IM +1	FR
2	GE Medical Systems SCS Buc Cedex	38	100%	RA	FR
3	Newclip Technics Haute-Goulaine	35	100%	OR	FR
4	Quantel Medical Cournon D'Auvergne-Cedex	30	100%	OP RA SU	FR
5	Sopro Marseille	25	100%	DE GU OB +3	FR
6	Medicrea International SA Neyron	25	100%	OR	FR
7	Satelec Merignac	24	100%	DE NE OR +1	FR
8	Horiba Abx Montpellier	19	100%	CH HE	FR
9	Mauna Kea Technologies Paris	18	100%	NE SU	FR
10	HORIBA ABX SAS Montpellier Cedex 4	18	100%	CH HE IM	FR
11	Supersonic Imagine Aix-En-Provence Cedex	16	100%	RA	FR
12	Biomerieux S.A. Craponne	16	100%	CH MI	FR
13	Trophy Marne La Vallee Cedex 2	15	100%	DE RA	FR
14	Safe Orthopaedics Eragny Sur Oise	13	100%	OR	FR
15	S.M.A.I.O Saint-Priest	13	100%	OR RA	FR
16	Trophy Radiologie Vincennes, Cedex (Paris)	12	100%	DE RA	FR
17	Clariance, Sas Beaurains	11	100%	OR	FR
18	Biomedical Diagnostics (Bmd) SA Marne La Vallee Cedex 2	10	100%	IM	FR
19	Memometal Technologies Bruz	10	100%	OR	FR
20	Biosphere Medical, S.A. Roissy-En-France	10	90%	CV GU NE	FR
21	Micro-Mega Societe Anonyme Besancon	9	100%	DE	FR
22	Arplay Medical S.A. Izeure, Cote D'Or	9	100%	RA	FR
23	Blue Ortho La Tronche	9	100%	NE OR	FR
24	FH Industrie Quimper Finistere	9	100%	OR RA	FR
25	Anthogyr Sallanches	8	100%	DE HO	FR
26	Medtech S.A Montpellier	8	100%	NE OR	FR
27	Fx Solutions Viriat	8	100%	OR	FR
28	Novastep Saint Gregoire	8	100%	OR	FR
29	Mallinckrodt Developpement France Villers-Les-Nancy Cedex	7	100%	AN	FR
30	Biomatlante Vigneux De Bretagne	7	100%	DE OR	FR
31	Peters Surgical Bobigny	7	100%	CV SU	FR
32	Koelis La Tronche	7	100%	RA	FR
33	Therapixel Valbonne	7	100%	RA	FR
34	Avicenna.Ai La Ciotat	7	100%	RA	FR
35	Ecential Robotics Gieres	7	100%	OR RA	FR
36	Science For Biomaterials Lourdes	6	100%	OR	FR
37	Laboratoires Urgo 21300 Chenove	6	100%	SU	FR
38	Cousin Biotech Sas Wervicq-Sud	6	100%	OR SU	FR
39	Anthogyr Sas Sallanches	6	100%	DE	FR
40	Sim&Cure Grabels	6	100%	CV NE	FR
41	Pixee Medical Besan?on	6	100%	OR RA	FR
42	Graftys Aix En Provence	5	100%	DE OR	FR
43	Therenva Sas Rennes	5	100%	RA	FR
44	Onefit Medical Besan?on	5	100%	RA	FR
45	Spineway Ecully	5	100%	OR	FR
46	Novatech SA La Ciotat Cedex	5	80%	AN EN SU	FR
47	Voluntis Sa. Paris	5	100%	CH HO	FR
48	Spinevision, S.A.S. Antony	5	100%	OR	FR
49	Volta Medical Marseille	5	100%	CV	FR
50	Sonio Paris	5	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.