Laerdal Medical AS is one of 8 FDA 510(k) medical device manufacturers from Norway in the dataset, ranked by real submission volume.
Laerdal Medical AS - FDA 510(k) Cleared Devices
Recent clearances: The BAG manual resuscitator and accessories, NeoBeat, NeoBeat Mini, Reusable Silicone Cover CPRmeter 2
5
Total
5
Cleared
0
Denied
Laerdal Medical AS has 5 FDA 510(k) cleared medical devices. Based in Stavanger, NO.
Latest FDA clearance: Nov 2025. Active since 2015. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Laerdal Medical AS Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Med Institute, Inc. and MED Institute.
FDA 510(k) Regulatory Record - Laerdal Medical AS
5 devices
Cleared
Nov 24, 2025
The BAG manual resuscitator and accessories
Anesthesiology
180d
Cleared
Jun 25, 2024
NeoBeat, NeoBeat Mini
Cardiovascular
347d
Cleared
Dec 17, 2018
Reusable Silicone Cover CPRmeter 2
Cardiovascular
14d
Cleared
Mar 23, 2018
CPRmeter 2 CPR Feedback Device
Cardiovascular
92d
Cleared
Aug 13, 2015
Reusable Full Silicone Cover
Cardiovascular
50d