Medical Device Manufacturer · DE , Hennigsdorf

Fiagon GmbH - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2014
15
Total
15
Cleared
0
Denied

Fiagon GmbH has 15 FDA 510(k) cleared ear, nose, throat devices. Based in Hennigsdorf, DE.

Last cleared in 2023. 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
15 devices
1-15 of 15
Cleared Nov 20, 2023
RIWOtrack Navigation System
K230700 · OLO
Orthopedic · 252d
Cleared May 26, 2023
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System,...
K230065 · PNZ
Ear, Nose, Throat · 137d
Cleared Jul 19, 2021
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation...
K211291 · PGW
Ear, Nose, Throat · 82d
Cleared Aug 26, 2020
VenSure Balloon Device, VenSure Nav Balloon Device
K201472 · LRC
Ear, Nose, Throat · 84d
Cleared Mar 10, 2020
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
K200041 · PGW
Ear, Nose, Throat · 62d
Cleared Sep 14, 2017
Fiagon Navigation System
K163209 · HAW
Neurology · 303d
Cleared Feb 16, 2017
Fiagon Navigation – PointerTube Straight and PointerTube Keat
K163416 · PGW
Ear, Nose, Throat · 73d
Cleared Dec 01, 2016
Fiagon Navigation System
K162176 · PGW
Ear, Nose, Throat · 120d
Cleared Sep 18, 2016
Guidewire 0.6 Single Use
K161940 · PGW
Ear, Nose, Throat · 66d
Cleared Apr 01, 2016
Fiagon Navigation System
K151156 · HAW
Neurology · 336d
Cleared Mar 23, 2016
PointerShell Universal, PointerShell LS
K160479 · PGW
Ear, Nose, Throat · 30d
Cleared Mar 10, 2016
GuideWire
K160369 · PGW
Ear, Nose, Throat · 29d
Cleared Apr 16, 2015
FlexPointer 1.5 mm
K150473 · PGW
Ear, Nose, Throat · 52d
Cleared Oct 08, 2014
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER,...
K141456 · PGW
Ear, Nose, Throat · 128d
Cleared Apr 30, 2014
FIAGON NAVIGATION SYSTEM
K133573 · PGW
Ear, Nose, Throat · 161d
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