FDA.report

Fiagon GMBH

Matched from indexed company URL: Fiagon GmbH

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30103135883010313588Fiagon GMBH1N2026-01-01Neuendorfstr. 23b Hennigsdorf Brandenburg DE 16761

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1713541702211551K230700RIWOtrack Navigation SystemOLO2023-11-20
1713541830886858K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemPNZ2023-05-26
1713541524698845K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW2021-07-19
1713541707489955K201472VenSure Balloon Device, VenSure Nav Balloon DeviceLRC2020-08-26
1713541236421636K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW2020-03-10
1713541117062388K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatPGW2017-02-16
1713541595423212K163209Fiagon Navigation SystemHAW2017-09-14
1713542009641097K162176Fiagon Navigation SystemPGW2016-12-01
1713541249902926K161940Guidewire 0.6 Single UsePGW2016-09-18
1713541864809421K160479PointerShell Universal, PointerShell LSPGW2016-03-23
1713541862384421K160369GuideWirePGW2016-03-10
1713541813860999K151156Fiagon Navigation SystemHAW2016-04-01
1713541165589680K150473FlexPointer 1.5 mmPGW2015-04-16
1713541456250866K141456THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELLPGW2014-10-08
1713541767512797K133573FIAGON NAVIGATION SYSTEMPGW2014-04-30

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
PGW102021-07-19
HAW22017-09-14
OLO12023-11-20
PNZ12023-05-26
LRC12020-08-26

PMN

GUDID

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