Ge Medical Systems,Llc (Ge Healthcare) 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
Sonic DL510(k)May 30, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 30, 2023
AIR Recon DL510(k)Jun 8, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 8, 2022