Brainlab SE 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
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine510(k)Sep 30, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 30, 2026
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface510(k)Jan 14, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jan 14, 2026