Medicel AG 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
ACCUJECT Injector Set 2.1-1P (LP604590)510(k)Sep 16, 2025Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Sep 16, 2025
Accuject Refra Injector AR2900510(k)Sep 19, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Sep 19, 2023