Coapt 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
Alpha Control Liner System (ACLS)510(k)Jan 11, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jan 11, 2023
ControlSeal Electrode (ELSB)510(k)Dec 30, 2022Neurology	Neurology	510(k)Substantially Equivalent (Special)	Dec 30, 2022