Topcon Healthcare Solutions EMEA Oy 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
Harmony Referral System with Harmony OCT Viewer (Octave)510(k)Jun 4, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 4, 2026
Harmony Referral System510(k)Sep 13, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2021