Resmed 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
Mariana Minerva; Mariana Nimbus510(k)Feb 23, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2026
AirFit F20 Mask System; AirFit F20 NM Mask System510(k)May 19, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 19, 2025