Cleerly, Inc. FDA Approvals

0 new drug approvals and 4 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
Cleerly Plaque510(k)Jul 29, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2026
Cleerly LABS510(k)Jul 29, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2026
Cleerly LABS (v2.0)510(k)Mar 7, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 7, 2025
Cleerly ISCHEMIA510(k)Sep 8, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 8, 2023