Mallinckrodt Manufacturing, LLC 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
EVOLVE Nitric Oxide Delivery System510(k)Jan 3, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Jan 3, 2025
Evolve Nitric Oxide Delivery System510(k)Dec 6, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2023
Inomax DSIR510(k)Apr 20, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 20, 2023