Laerdal Medical AS FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
The BAG manual resuscitator and accessories510(k)Nov 24, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Nov 24, 2025
NeoBeat, NeoBeat Mini510(k)Jun 25, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 25, 2024