Manufacturer Intelligence · Based on 150,872 FDA 510(k) records · 85 countries

FDA 510(k) Medical Device Manufacturers - Denmark

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

Danish 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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100

Manufacturers

Denmark

Country

Denmark FDA 510(k) Overview

100

Manufacturers

311

Submissions

99%

Clearance rate

Leading Denmark FDA 510(k) manufacturers include Radiometer Medical Aps, Tonica Elektronik A/S, William Cook Europe Aps and 97 others.

Danish medical device manufacturers have submitted 311 FDA 510(k) notifications since 1992, achieving a 99.4% clearance rate across 100 manufacturers. Denmark's medtech sector reflects the country's specialization in hearing instruments, diabetes management devices and advanced diagnostics, with a historically high per-capita medical device innovation rate.

Active in FDA 510(k) submissions since 1992. Many Denmark manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Denmark Manufacturers

1–50 of 100

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Radiometer Medical Aps Bronshoj	28	100%	AN CH	DK
2	Tonica Elektronik A/S Farum	18	100%	NE PM	DK
3	William Cook Europe Aps Bjaeverskov	18	100%	AN CV	DK
4	Elos Medtech Pinol A/S Goerloese	14	100%	DE	DK
5	Unomedical A/S Roskilde	13	100%	CH HO	DK
6	B & K Medical A/S Dk 2820 Gentofte	11	100%	RA	DK
7	Medtronic Functional Diagnostics A/S Skovlunde	11	100%	GU NE	DK
8	B-K Medical Aps Herlev	11	100%	GU RA	DK
9	Bk Medical Aps Herlev	9	100%	RA	DK
10	3Shape A/S Copenhagen	8	100%	DE	DK
11	Ellipse A/S Hoersholm	7	100%	SU	DK
12	Danish Diagnostic Development A/S 2970 Horshom	6	100%	RA	DK
13	Gn Otometrics A/S Taastrup	6	100%	EN NE	DK
14	Polystan A/S Denmark	5	100%	CV	DK
15	Club Hearing Instruments A/S Denmark, 2900	5	100%	EN	DK
16	GN Hearing A/S Ballerup	5	100%	EN	DK
17	Radiometer Medicals Aps Br?nsh?j	5	100%	CH	DK
18	Danmeter A/S Odense C	4	100%	GU NE PM	DK
19	Unisense Fertilitech A/S Arrhus	4	100%	OB	DK
20	Vitrolife A/S Viby J	4	100%	OB	DK
21	Cercare Medical A/S Aarhus	4	100%	RA	DK
22	S & W Medico Teknik A/S Albertslund	3	100%	CV	DK
23	Rtx Healthcare A/S Noerresundby	3	100%	CV	DK
24	Danish Dermatologic Development A/S Horsholm	3	100%	SU	DK
25	Gn Resound A/S Ballerup	3	100%	EN	DK
26	Medart A/S Hvidovre	3	100%	SU	DK
27	3Shape Medical A/S Copenhagen	3	100%	RA	DK
28	Norlase Aps Ballerup	3	100%	OP	DK
29	Artsmedia Denmark Aps Virum	3	100%	OB	DK
30	3Shape TRIOS A/S Copenhagen	3	100%	DE	DK
31	Radiometer Medical A/S Bronshoj	2	100%	AN CH	DK
32	Osteometer Biotech A/S Herlev	2	100%	CH	DK
33	Ronvig A/S Dk-8721 Daugaard	2	100%	DE	DK
34	Scandimed. A.S. Glostrop	2	100%	GU	DK
35	Nunc A/S Roskilde	2	100%	OB	DK
36	Powermedic Aps Holbaek	2	100%	PM	DK
37	Scandimed International Glostrop	2	100%	GU	DK
38	Hertart Greve	2	100%	OB	DK
39	Ddd-Diagnostic A/S Denmark	2	100%	RA	DK
40	Dako Denmark A/S Golstrup	2	100%	PA	DK
41	Nrt X-Ray A/S Hasselager	2	100%	RA	DK
42	Motilitycount Aps Valby	2	100%	HE OB	DK
43	Cath Vision Aps Copenhagen N	2	100%	CV	DK
44	Wsaud A/S Lynge	2	100%	EN	DK
45	Aw Technologies Aps Norresundby	2	100%	AN	DK
46	Mequ A/S Kobenhavn N	2	100%	HO	DK
47	Lysta A/S Farum	2	100%	DE	DK
48	ROPCA ApS Odense M	2	100%	RA	DK
49	Multicept, Aps. Copenhagen	1	100%	OB	DK
50	Biometer Intl. A/S Denmark	1	100%	AN	DK

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.