DRGEM Corporation FDA Approvals

0 new drug approvals and 5 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
RAYMO Mobile X-ray System (Model: RAYMO)510(k)May 14, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 14, 2026
PROMO510(k)Aug 22, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 22, 2025
GXR-Series Diagnostic X-Ray System510(k)Jan 7, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 7, 2025
TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)510(k)Dec 16, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 16, 2024
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)510(k)Sep 19, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 19, 2023