Fiagon GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Fiagon GmbH - FDA 510(k) Cleared Devices
Recent clearances: Cube 4D Navigation System, VirtuEye Pro, RIWOtrack Navigation System, VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
16
Total
16
Cleared
0
Denied
Fiagon GmbH has 16 FDA 510(k) cleared ear, nose, throat devices. Based in Hennigsdorf, DE.
Latest FDA clearance: Jun 2026. Active since 2014.
Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Fiagon GmbH
16 devices
Cleared
Jun 02, 2026
Cube 4D Navigation System, VirtuEye Pro
Ear, Nose, Throat
25d
Cleared
Nov 20, 2023
RIWOtrack Navigation System
Orthopedic
252d
Cleared
May 26, 2023
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System,...
Ear, Nose, Throat
137d
Cleared
Jul 19, 2021
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation...
Ear, Nose, Throat
82d
Cleared
Aug 26, 2020
VenSure Balloon Device, VenSure Nav Balloon Device
Ear, Nose, Throat
84d
Cleared
Mar 10, 2020
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Ear, Nose, Throat
62d
Cleared
Sep 14, 2017
Fiagon Navigation System
Neurology
303d
Cleared
Feb 16, 2017
Fiagon Navigation – PointerTube Straight and PointerTube Keat
Ear, Nose, Throat
73d
Cleared
Dec 01, 2016
Fiagon Navigation System
Ear, Nose, Throat
120d
Cleared
Sep 18, 2016
Guidewire 0.6 Single Use
Ear, Nose, Throat
66d
Cleared
Apr 01, 2016
Fiagon Navigation System
Neurology
336d
Cleared
Mar 23, 2016
PointerShell Universal, PointerShell LS
Ear, Nose, Throat
30d