GE Medical Systems 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
AIR Recon DL510(k)Aug 13, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 13, 2026
Venue Fit510(k)Jun 27, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 27, 2022
Venue510(k)Jun 27, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 27, 2022