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Fiagon GmbH

16 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Cube 4D Navigation System, VirtuEye Pro (K261540)Fiagon GmbH2026-06-02
RIWOtrack Navigation System (K230700)Fiagon GmbH2023-11-20
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (K230065)Fiagon GmbH2023-05-26
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (K211291)Fiagon GmbH2021-07-19
VenSure Balloon Device, VenSure Nav Balloon Device (K201472)Fiagon GmbH2020-08-26
FlexPointer 1.5 Single Use, FlexTube 3 Single Use (K200041)Fiagon GmbH2020-03-10
Fiagon Navigation System (K163209)Fiagon GmbH2017-09-14
Fiagon Navigation – PointerTube Straight and PointerTube Keat (K163416)Fiagon GmbH2017-02-16
Fiagon Navigation System (K162176)Fiagon GmbH2016-12-01
Guidewire 0.6 Single Use (K161940)Fiagon GmbH2016-09-18
Fiagon Navigation System (K151156)Fiagon GmbH2016-04-01
PointerShell Universal, PointerShell LS (K160479)Fiagon GmbH2016-03-23
GuideWire (K160369)Fiagon GmbH2016-03-10
FlexPointer 1.5 mm (K150473)Fiagon GmbH2015-04-16
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL (K141456)Fiagon GmbH2014-10-08
FIAGON NAVIGATION SYSTEM (K133573)Fiagon GmbH2014-04-30

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Every clearance here is in the API, with alerts when new ones post.