Manufacturer Intelligence · Based on 176,107 FDA 510(k) records · 90 countries

FDA 510(k) Medical Device Manufacturers - Norway

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

Norwegian medical device manufacturers ranked by FDA 510(k) submission volume. Rankings generated directly from FDA accessdata.gov — no editorial curation, no paid listings.

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Manufacturers

Norway

Country

Norway FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Norway FDA 510(k) manufacturers include Ge Vingmed Ultrasound AS, Nordicneurolab AS, Laerdal Medical AS and 19 others.

Norwegian medical device manufacturers have submitted 52 FDA 510(k) notifications since 1985, achieving a 100% clearance rate across 22 manufacturers. Norway's medtech sector shows specialization in cardiovascular monitoring, point-of-care diagnostics and digital health solutions, reflecting the country's advanced healthcare system and technology innovation capacity.

Active in FDA 510(k) submissions since 1985. Many Norway manufacturers work with FDA regulatory consultants to support U.S. market entry.

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Ranking period: All time Last 5 yrs Last 3 yrs

FDA 510(k) Norway Manufacturers

1–22 of 22

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Ge Vingmed Ultrasound AS Horten	10	100%	RA	NO
2	Nordicneurolab AS Bergen	7	100%	RA	NO
3	Laerdal Medical AS Stavanger	5	100%	AN CV	NO
4	Laerdal Medical A/S Stavanger	4	100%	AN CV SU	NO
5	Vingmed Sound, Inc. Horten	3	100%	RA	NO
6	Nordicimaginglab AS Bergen, Hordaland	3	100%	RA	NO
7	Alere Technologies AS Oslo	3	100%	CH	NO
8	Conceptomed AS Ballstad	2	100%	HO	NO
9	Holberg Eeg AS Bergen	2	100%	NE	NO
10	Madshus A/S Biri	1	100%	HO	NO
11	Normeca Corp. Skaarer	1	100%	HO	NO
12	Nycomed Pharma AS N-40401 Oslo 4, Norway	1	100%	HE	NO
13	Medsafe Asa Oslo	1	100%	HO	NO
14	Tunstall Healthcare Noerresundby	1	100%	CV	NO
15	Fimreite Software AS Horten	1	100%	RA	NO
16	Medical Rescue Equipment Holding AS Porsgrunn	1	100%	HO	NO
17	Biim Ultrasound AS Narvik	1	100%	RA	NO
18	Abbott Diagnostics Technologies AS Oslo	1	100%	CH	NO
19	Odi Medical AS Oslo	1	100%	SU	NO
20	Mode Sensors AS Trondheim	1	100%	CV	NO
21	Excitus AS Stavanger	1	100%	SU	NO
22	Ge Vingmed Ultrasound Horten	1	100%	RA	NO

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. Rankings reflect real regulatory activity — no paid placements, no self-reported data.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.

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