Claritas Healthtech Pte, Ltd. 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
iPETcertum (v1.0)510(k)Aug 5, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 5, 2025
Claritas iPET510(k)Dec 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
iRAD510(k)Oct 20, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 20, 2021