Ultromics Limited 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
EchoGo Amyloidosis (1.0)510(k)Nov 15, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
EchoGo Heart Failure (2.0)510(k)Sep 23, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 23, 2024
EchoGo Heart Failure510(k)Nov 23, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 23, 2022
EchoGo Core (2.0)510(k)Dec 20, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 20, 2021