Ellex Medical 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
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo510(k)Nov 2, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Nov 2, 2022
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo510(k)Dec 16, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Dec 16, 2021