Brainlab , Ltd. 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
TraumaCad Neo (1.1)510(k)Jun 4, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 4, 2025
TraumaCad Neo510(k)Nov 20, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 20, 2023