Eko.Ai Pte Ltd. D/B/A Us2.Ai 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
Us2.ca510(k)Jun 20, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 20, 2025
Us2.v2510(k)Apr 1, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 1, 2024
Us2.v1510(k)Jul 27, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 27, 2021