Fiagon GmbH FDA Approvals

0 new drug approvals and 4 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
Cube 4D Navigation System, VirtuEye Pro510(k)Jun 2, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jun 2, 2026
RIWOtrack Navigation System510(k)Nov 20, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 20, 2023
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System510(k)May 26, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 26, 2023
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D510(k)Jul 19, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 19, 2021