Gleamer 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
ChestView US (1.1)510(k)Sep 9, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 9, 2026
BoneView510(k)Mar 2, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 2, 2023
BoneView510(k)Mar 1, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 1, 2022