Manufacturer Intelligence · Based on 21,267 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - Switzerland

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

Swiss 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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Manufacturers

Switzerland

Country

Switzerland FDA 510(k) Overview

Manufacturers

345

Submissions

100%

Clearance rate

Leading Switzerland FDA 510(k) manufacturers include Medacta International S.A., Institut Straumann AG, Stryker GmbH and 74 others.

Swiss medical device manufacturers have submitted 345 FDA 510(k) notifications since 2019, with a 99.7% clearance rate across 77 manufacturers. Switzerland's medtech sector reflects the country's strength in precision instruments, dental systems, surgical robotics and advanced diagnostic technologies, with a high submission-to-clearance efficiency.

Active in FDA 510(k) submissions since 2019. Many Switzerland manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Switzerland Manufacturers

1–50 of 77

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Medacta International S.A. Castel San Pietro	112	100%	OR RA SU	CH
2	Institut Straumann AG Basel	35	100%	DE HO	CH
3	Stryker GmbH Selzach, Solothurn, Ch	34	100%	OR	CH
4	Spineart Geneva	12	100%	OR	CH
5	Spineart SA Plan-Les-Ouates	10	100%	OR	CH
6	Bonebridge AG Zug	9	100%	OR	CH
7	Synthes GmbH Zuchwil	7	100%	HO NE OR	CH
8	Medela AG Ch-6340 Baar	5	100%	OB SU	CH
9	Nobel Biocare Services AG Kloten	5	100%	DE HO	CH
10	Cascination AG Bern	4	100%	EN RA	CH
11	Medacta Inernational SA Castel San Pietro (Ch)	4	100%	OR	CH
12	Spd Swiss Precision Diagnostics GmbH Geneva	4	100%	CH	CH
13	Zimmer Switzerland Manufacturing GmbH Winterthur	4	100%	OR	CH
14	Saremco Dental AG Rebstein	4	100%	DE	CH
15	Dent4you AG Heerbrugg	4	100%	DE	CH
16	Enbio Group AG Oensingen	3	100%	HO	CH
17	Medos International S?rl Lelocle	3	100%	OR	CH
18	Neo Medical SA Villette (Lavaux)	3	100%	OR	CH
19	Naviswiss AG Brugg	3	100%	OR RA	CH
20	Sleepiz AG Zurich	3	100%	CV	CH
21	Distalmotion SA Epalinges	3	67%	SU	CH
22	Cequr SA Horw Luzern	3	100%	CH	CH
23	Schiller AG Baar	2	100%	CV	CH
24	Ardo Medical AG Unterageri	2	100%	OB	CH
25	Meridian AG Thun, Bern	2	100%	OP	CH
26	Bien-Air Surgery SA Le Noirmont	2	100%	EN NE	CH
27	Tri Dental Implants Int. AG Baar	2	100%	DE	CH
28	Ndd Medizintechnik AG Zurich	2	100%	AN HO	CH
29	Storz Medical AG Tagerwilen	2	100%	PM SU	CH
30	Nobel Biocare AG Kloten	2	100%	DE	CH
31	Getset Surgical, SA Epalinges	2	100%	OR	CH
32	Aspivix SA Renens	2	100%	OB	CH
33	Comerge AG Zurich	2	100%	CH OR	CH
34	Sonova AG Zurich	2	100%	EN	CH
35	Smartcardia SA Lausanne	2	100%	CV	CH
36	Lumendo AG Renens	2	100%	DE	CH
37	Surgical Fusion Technologies GmbH Schlieren	2	100%	OR	CH
38	ZuriMED Technologies AG Zurich	2	100%	OR	CH
39	Sic Invent AG Basel	1	100%	DE	CH
40	Cendres & Metaux SA Biel/Bienne	1	100%	DE	CH
41	Ypsomed AG Burgdorf	1	100%	HO	CH
42	Medimaps Group SA Plan Les Ouates	1	100%	RA	CH
43	Oertli Instrumente AG Berneck	1	100%	OP	CH
44	Sie Ag,Surgical Instrument Engineering Port	1	100%	OP	CH
45	Coligne AG Zurich	1	100%	OR	CH
46	Novodent SA Yverdons-Les-Bains	1	100%	DE	CH
47	Sds Swiss Dental Solutions AG Kreuzlingen	1	100%	DE	CH
48	Lifescan Europe GmbH Zug	1	100%	CH	CH
49	Ava AG Zurich	1	100%	OB	CH
50	Clever Culture Systems Bach	1	100%	MI	CH

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.