Headsafe Mfg Pty, 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
Nurochek-Pro System510(k)Mar 27, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 27, 2025
Nurochek-II System510(k)Dec 27, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 27, 2023