Itamar Medical , Ltd. FDA Approvals

0 new drug approvals and 6 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
WatchPAT SW510(k)Jul 31, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
WatchPAT400 (WP400)510(k)Sep 5, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 5, 2025
WatchPAT ONE (WP1)510(k)Jan 6, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Jan 6, 2023
EndoPATx510(k)Dec 29, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 29, 2022
WatchPAT300 (WP300)510(k)Sep 14, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Sep 14, 2022
WatchPAT200U (WP200U)510(k)Mar 21, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 21, 2022