Manufacturer Intelligence · Based on 57,940 FDA 510(k) records · 74 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

456

Submissions

100%

Clearance rate

Leading Switzerland FDA 510(k) manufacturers include Medacta International S.A., Institut Straumann AG, Stryker GmbH and 89 others.

Swiss medical device manufacturers have submitted 456 FDA 510(k) notifications since 2008, with a 99.8% clearance rate across 92 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 2008. Many Switzerland manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Switzerland Manufacturers

1–50 of 92

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Medacta International S.A. Castel San Pietro	165	100%	NE OR RA +1	CH
2	Institut Straumann AG Basel	54	100%	DE HO	CH
3	Stryker GmbH Selzach, Solothurn, Ch	40	100%	OR	CH
4	Spineart Geneva	16	100%	OR	CH
5	Spineart SA Plan-Les-Ouates	11	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	7	100%	OB SU	CH
9	Neo Medical SA Villette (Lavaux)	5	100%	OR	CH
10	Nobel Biocare Services AG Kloten	5	100%	DE HO	CH
11	Cascination AG Bern	4	100%	EN RA	CH
12	Medacta Inernational SA Castel San Pietro (Ch)	4	100%	OR	CH
13	Spd Swiss Precision Diagnostics GmbH Geneva	4	100%	CH	CH
14	Zimmer Switzerland Manufacturing GmbH Winterthur	4	100%	OR	CH
15	Saremco Dental AG Rebstein	4	100%	DE	CH
16	Dent4you AG Heerbrugg	4	100%	DE	CH
17	Enbio Group AG Oensingen	3	100%	HO	CH
18	Sic Invent AG Basel	3	100%	DE	CH
19	Bien-Air Surgery SA Le Noirmont	3	100%	EN NE	CH
20	Medos International S?rl Lelocle	3	100%	OR	CH
21	Coligne AG Zurich	3	100%	OR	CH
22	Storz Medical AG Tagerwilen	3	100%	PM SU	CH
23	Naviswiss AG Brugg	3	100%	OR RA	CH
24	Sleepiz AG Zurich	3	100%	CV	CH
25	Distalmotion SA Epalinges	3	67%	SU	CH
26	Cequr SA Horw Luzern	3	100%	CH	CH
27	Schiller AG Baar	2	100%	CV	CH
28	Ardo Medical AG Unterageri	2	100%	OB	CH
29	Meridian AG Thun, Bern	2	100%	OP	CH
30	Lucenxia Prescience AG Baar	2	100%	HO	CH
31	Tri Dental Implants Int. AG Baar	2	100%	DE	CH
32	Ndd Medizintechnik AG Zurich	2	100%	AN HO	CH
33	Novodent SA Yverdons-Les-Bains	2	100%	DE	CH
34	Sds Swiss Dental Solutions AG Kreuzlingen	2	100%	DE	CH
35	Nobel Biocare AG Kloten	2	100%	DE	CH
36	Getset Surgical, SA Epalinges	2	100%	OR	CH
37	Aspivix SA Renens	2	100%	OB	CH
38	Comerge AG Zurich	2	100%	CH OR	CH
39	Sonova AG Zurich	2	100%	EN	CH
40	Smartcardia SA Lausanne	2	100%	CV	CH
41	Lumendo AG Renens	2	100%	DE	CH
42	Surgical Fusion Technologies GmbH Schlieren	2	100%	OR	CH
43	ZuriMED Technologies AG Zurich	2	100%	OR	CH
44	Cendres & Metaux SA Biel/Bienne	1	100%	DE	CH
45	Ypsomed AG Burgdorf	1	100%	HO	CH
46	Medimaps Group SA Plan Les Ouates	1	100%	RA	CH
47	Oertli Instrumente AG Berneck	1	100%	OP	CH
48	Clever Culture Systems AG Baech	1	100%	MI	CH
49	Sie Ag,Surgical Instrument Engineering Port	1	100%	OP	CH
50	Mindmaze SA Lausanne	1	100%	PM	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.