Manufacturer Intelligence · Based on 84,757 FDA 510(k) records · 74 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. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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Manufacturers

Norway

Country

Norway FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Norway FDA 510(k) manufacturers include Nordicneurolab AS, Laerdal Medical AS, Alere Technologies AS and 5 others.

Norwegian medical device manufacturers have submitted 18 FDA 510(k) notifications since 2018, achieving a 100% clearance rate across 8 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 2018. Many Norway manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Norway Manufacturers

1–8 of 8

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Nordicneurolab AS Bergen	6	100%	RA	NO
2	Laerdal Medical AS Stavanger	4	100%	AN CV	NO
3	Alere Technologies AS Oslo	2	100%	CH	NO
4	Holberg Eeg AS Bergen	2	100%	NE	NO
5	Abbott Diagnostics Technologies AS Oslo	1	100%	CH	NO
6	Odi Medical AS Oslo	1	100%	SU	NO
7	Mode Sensors AS Trondheim	1	100%	CV	NO
8	Excitus AS Stavanger	1	100%	SU	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. 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.