Fiagon GmbH - FDA 510(k) Cleared Devices
15
Total
15
Cleared
0
Denied
FDA 510(k) cleared devices by Fiagon GmbH Ear, Nose, Throat ✕
12 devices
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
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
Mar 23, 2016
PointerShell Universal, PointerShell LS
Ear, Nose, Throat
30d
Cleared
Mar 10, 2016
GuideWire
Ear, Nose, Throat
29d
Cleared
Apr 16, 2015
FlexPointer 1.5 mm
Ear, Nose, Throat
52d
Cleared
Oct 08, 2014
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER,...
Ear, Nose, Throat
128d
Cleared
Apr 30, 2014
FIAGON NAVIGATION SYSTEM
Ear, Nose, Throat
161d