Manufacturer Intelligence · Based on 149,759 FDA 510(k) records · 85 countries

FDA 510(k) Medical Device Manufacturers - Sweden

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

Swedish 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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125

Manufacturers

Sweden

Country

Sweden FDA 510(k) Overview

125

Manufacturers

555

Submissions

99%

Clearance rate

Leading Sweden FDA 510(k) manufacturers include Nobel Biocare AB, Ab Biodisk, Phadia AB and 122 others.

Swedish medical device manufacturers have submitted 555 FDA 510(k) notifications since 1990, achieving a 99.1% clearance rate across 125 manufacturers. Sweden's medtech sector shows activity in cardiovascular monitoring, orthopedic devices, audiology systems and point-of-care diagnostics, reflecting the country's longstanding innovation in life sciences.

Active in FDA 510(k) submissions since 1990. Many Sweden manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Sweden Manufacturers

1–50 of 125

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Nobel Biocare AB Goteborg	94	100%	DE HO RA +1	SE
2	Ab Biodisk Solna	64	100%	MI	SE
3	Phadia AB Uppsala	33	100%	IM	SE
4	Radi Medical Systems AB Uppsala	24	100%	CV RA SU	SE
5	Oticon Medical AB Gothenburg, Askim	17	100%	EN HO	SE
6	Hermes Medical Solutions AB Stockholm	17	100%	RA	SE
7	Icotec AG Altstaetten	16	100%	OR	SE
8	Elekta Solutions AB Stockholm	15	100%	NE RA	SE
9	Breas Medical AB Molnlycke, Vastra Gotaland	15	100%	AN	SE
10	RaySearch Laboratories AB (PUBL) Stockholm	15	100%	RA	SE
11	Icor AB Bromma	8	100%	AN	SE
12	Carmel Pharma Ab. Gothenburg	7	100%	HO	SE
13	Raysearch Laboratories AB Stockholm	7	100%	RA	SE
14	Althin Medical AB 372 21 Ronneby	7	100%	GU	SE
15	Euro-Diagnostica AB Malmo	6	100%	IM	SE
16	C-Rad Positioning AB Uppsala	6	100%	RA	SE
17	Clinical Laserthermia Systems, AB Lund	6	100%	NE SU	SE
18	Syntheticmr AB Linkoping	6	100%	RA	SE
19	Natural Cycles Nordic AB Stockholm	6	83%	OB	SE
20	Scandidos AB Uppsala	5	100%	RA	SE
21	St. Jude Medical Systems AB Uppsala	5	100%	CV	SE
22	Abigo Medical AB Sweden	4	100%	SU	SE
23	Schneider (Europe) GmbH Bulach	4	100%	CV GU	SE
24	Scanditronix Medical AB Uppsala S-754 50	4	100%	RA	SE
25	Perimed AB Jarfalla	4	100%	AN CV	SE
26	Qbtech AB Goteborg	4	100%	NE	SE
27	Naslund Medical AB Huddinge	4	100%	RA	SE
28	Xvivo Perfusion AB Gutengurg	4	100%	GU	SE
29	Braincool AB Medicon Village	4	75%	CV DE	SE
30	Ortoma AB Goteborg	4	100%	OR	SE
31	Branemark Integration AB Gotborg	3	100%	DE	SE
32	Philips Digital Mammography Sweden AB Solna	3	100%	RA	SE
33	Apriomed AB Uppsala	3	100%	GU SU	SE
34	Toul Meditech AB V?ster?s	3	100%	HO SU	SE
35	Solutions For Tomorrow AB Vackelsang	3	100%	RA	SE
36	Senzime AB Uppsala	3	100%	AN	SE
37	Wellspect AB M?lndal	3	100%	GU	SE
38	Helax AB Uppsala	3	100%	RA	SE
39	Neko Health AB Danderyd	3	100%	CV RA SU	SE
40	Svenska Dental Instruments AB Sweden	2	100%	DE	SE
41	Chromogenix AB Molndal	2	100%	HE	SE
42	Ab Biodisk North America, Inc. S-17136 Solna, Sweden	2	100%	MI	SE
43	Bregas AB Bromma	2	100%	AN	SE
44	Context Vision AB Linkoping	2	100%	RA	SE
45	Wellhofer Dosimetrie Uppsala	2	100%	RA	SE
46	Cresco TI Systems AB Kristianstad	2	100%	DE	SE
47	Arcoma AB Vaxjo	2	100%	RA	SE
48	Ab Biomerieux Solna	2	100%	MI	SE
49	Aidera AB Goteborg	2	100%	HO	SE
50	Oncolog Medical QA AB Uppsala	2	100%	RA	SE

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.