Aerogen, 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
Aerogen Pro-X1 Controller System510(k)Sep 2, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 2, 2025
Aerogen®Solo Nebulizer System510(k)May 10, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 10, 2024