Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) FDA Approvals

0 new drug approvals and 3 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
Natus BrainWatch System510(k)Nov 19, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 19, 2024
ALGO Pro Newborn Hearing Screener (ALGO Pro)510(k)Mar 8, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 8, 2024
RetCam Envision510(k)Apr 13, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Apr 13, 2021