UC-CARE , Ltd. 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
SmartGuide Disposable Guides and Grids510(k)Jul 30, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2026
Navigo Workstation 2.3 (FPRMC00039)510(k)Aug 7, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 7, 2025