Manufacturer Intelligence · Based on 21,315 FDA 510(k) records · 72 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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Manufacturers

Sweden

Country

Sweden FDA 510(k) Overview

Manufacturers

136

Submissions

99%

Clearance rate

Leading Sweden FDA 510(k) manufacturers include Nobel Biocare AB, Elekta Solutions AB, Icotec AG and 51 others.

Swedish medical device manufacturers have submitted 136 FDA 510(k) notifications since 2019, achieving a 98.5% clearance rate across 52 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 2019. Many Sweden manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Sweden Manufacturers

1–50 of 54

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Nobel Biocare AB Goteborg	15	100%	DE HO RA	SE
2	Elekta Solutions AB Stockholm	14	100%	RA	SE
3	Icotec AG Altstaetten	13	100%	OR	SE
4	Phadia AB Uppsala	9	100%	IM	SE
5	RaySearch Laboratories AB (PUBL) Stockholm	9	100%	RA	SE
6	Breas Medical AB Molnlycke, Vastra Gotaland	6	100%	AN	SE
7	Hermes Medical Solutions AB Stockholm	5	100%	RA	SE
8	Oticon Medical AB Gothenburg, Askim	4	100%	EN	SE
9	Natural Cycles Nordic AB Stockholm	4	100%	OB	SE
10	Clinical Laserthermia Systems, AB Lund	3	100%	NE SU	SE
11	C-Rad Positioning AB Uppsala	2	100%	RA	SE
12	Naslund Medical AB Huddinge	2	100%	RA	SE
13	Braincool AB Medicon Village	2	50%	CV DE	SE
14	Syntheticmr AB Linkoping	2	100%	RA	SE
15	Solutions For Tomorrow AB Vackelsang	2	100%	RA	SE
16	Ortoma AB Goteborg	2	100%	OR	SE
17	Nuvoair AB Stockholm	2	100%	AN	SE
18	Coroventis Research AB Uppsala	2	100%	CV	SE
19	Q-Linea AB Uppsala	2	100%	MI	SE
20	Syntheticmr AB (Publ.) Link?ping	2	100%	RA	SE
21	Suturion AB Lund	2	100%	SU	SE
22	Wellspect AB M?lndal	2	100%	GU	SE
23	Amferia AB Molndal	1	0%	SU	SE
24	Scandidos AB Uppsala	1	100%	RA	SE
25	Xvivo Perfusion AB Gutengurg	1	100%	GU	SE
26	Apriomed AB Uppsala	1	100%	SU	SE
27	Novus Scientific AB Uppsala	1	100%	SU	SE
28	Medviso AB Lund	1	100%	RA	SE
29	Amra Medical AB Linkoping	1	100%	RA	SE
30	Miris AB Uppsala	1	100%	CH	SE
31	Medifactia AB Gothenburg	1	100%	GU	SE
32	Coala Life AB Stockholm	1	100%	CV	SE
33	Senzime AB Uppsala	1	100%	AN	SE
34	Maquet Critica Care AB Solna	1	100%	AN	SE
35	Peptonic Medical AB Bromma	1	100%	OB	SE
36	Hertart Aps V?stra Fr?lunda	1	100%	OB	SE
37	Pharma System AB Knivsta	1	100%	HO	SE
38	Biovica International AB Uppsala	1	100%	IM	SE
39	Micropos Medical AB Gothenburg	1	100%	RA	SE
40	Minitube AB Tr?ngsviken	1	100%	DE	SE
41	Spectronic Medical AB Helsingborg	1	100%	RA	SE
42	Bibbinstruments AB Lund	1	100%	GU	SE
43	SmartWise Sweden AB Tullinge	1	100%	CV	SE
44	Neodynamics AB Lidingo	1	100%	SU	SE
45	Panthera AB Stockholm	1	100%	PM	SE
46	Duearity AB Malmo	1	100%	EN	SE
47	Algodx AB Stockholm	1	100%	CV	SE
48	Hidroxa Medical AB Partille	1	100%	PM	SE
49	Xaga Surgical Helsingborg	1	100%	GU	SE
50	Neoventa Medical AB M?lndal	1	100%	OB	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.