Fiagon G M B H

FDA Filings

This page includes the latest FDA filings for Fiagon G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010313588
FEI Number3010313588
NameFIAGON GMBH
Owner & Operatorfiagon GmbH
Contact AddressNeuendorfstr. 23b
Hennigsdorf DE-BB Brandenburg 16761 DE
Official Correspondent
  • Dirk Mucha
  • 049-3302-20121-24
US Agent
Importing Logistics Registration
ImporterFiagon NA Corporation
Address3913 Todd Lane Bld 100 Ste #101
Austin, TX 78744 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNeuendorfstr. 23b
Hennigsdorf Brandenburg, 16761 DE
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Fiagon GmbH
VenSure Balloon Device, VenSure Nav Balloon Device2020-08-26
Fiagon GmbH
Fiagon Navigation Unit 2020-05-13
Fiagon GmbH
Localizer Bone Anchor 2020-04-06
Fiagon GmbH
Localizer Adhesive pad 2020-04-06
Fiagon GmbH
FlexPointer 1.5 Cranial 2020-04-06
Fiagon GmbH
ShuntPointer 2020-03-30
Fiagon GmbH
BiopsyPointer 250 2020-03-30
Fiagon GmbH
BiopsyPointer 190 2020-03-30
Fiagon GmbH
Guidewire 0.6 2020-03-30
Fiagon GmbH
Guidewire 2020-03-30
Fiagon GmbH
VenteraPointer 2020-03-30
Fiagon GmbH
PointerShell LS 2020-03-30
Fiagon GmbH
PointerShell Universal 2020-03-30
Fiagon GmbH
PointerShell 3 mm 2020-03-30
Fiagon GmbH
PointerShell 5 mm 2020-03-30
Fiagon GmbH
PointerShell 4 mm 2020-03-30
Fiagon GmbH
FinePointer Cranial 2020-03-30
Fiagon GmbH
FinePointer 2020-03-30
Fiagon GmbH
Localizer Adhesive pad Cranial 2020-03-30
Fiagon GmbH
Localizer Adhesive pad 2020-03-30
Fiagon GmbH
Localizer Headband 2020-03-30
Fiagon GmbH
PointerTube Kennedy 2020-03-30
Fiagon GmbH
PointerTube Keat 2020-03-30
Fiagon GmbH
FlexTube 4 mm 2020-03-30
Fiagon GmbH
FlexTube 3mm 2020-03-30
Fiagon GmbH
PointerTube Sinus Frontalis 2020-03-30
Fiagon GmbH
PointerTube Stammberger 2020-03-30
Fiagon GmbH
PointerTube Straight 2020-03-30
Fiagon GmbH
FlexPointer 1.5 2020-03-30
Fiagon GmbH
RegistrationPointer Cranial 2020-03-30
Fiagon GmbH
RegistrationPointer 2020-03-30
Fiagon GmbH
FlexPointer Cranial 2020-03-30
Fiagon GmbH
FlexPointer 2020-03-30
FIAGON GMBH
FlexTube 3 Single Use2020-03-27
FIAGON GMBH
FlexPointer 1.5 Single Use2020-03-27
Fiagon GmbH
FlexPointer 1.5 Single Use, FlexTube 3 Single Use2020-03-10
Fiagon GmbH
Navigation Sensor Mayfield 2018-07-06
Fiagon GmbH
FlexPointer 1.5 Cranial 2018-07-06
Fiagon GmbH
Fiagon Navigation Unit Cranial 2018-07-06
Fiagon GmbH
Guidewire 0.6 Single Use 2018-03-29
Fiagon GmbH
Navigation Headrest Trumpf 2018-03-29
Fiagon GmbH
Navigation Headrest Universal 2018-03-29
Fiagon GmbH
Navigation Headrest Maquet 2018-03-29
Fiagon GmbH
Navigation Headrest Flat 2018-03-29
Fiagon GmbH
Headband 2018-03-29
Fiagon GmbH
MapperFrame 2018-03-29
FIAGON GMBH
ShuntPointer2017-12-18
FIAGON GMBH
Navigation Unit2017-12-18
FIAGON GMBH
Localizer Bone Anchor2017-12-18
FIAGON GMBH
Localizer Adhesive Pad2017-12-18
FIAGON GMBH
BiopsyPointer 2502017-12-18
FIAGON GMBH
BiopsyPointer 1902017-12-18
FIAGON GMBH
Fiagon Navigation System2017-09-14
FIAGON GMBH
PointerTube Kennedy2017-04-19
FIAGON GMBH
PointerTube Keat2017-04-19
FIAGON GMBH
GuideWire 0.6 Single Use2017-02-22
FIAGON GMBH
Fiagon Navigation – PointerTube Straight And PointerTube Keat2017-02-16
FIAGON GMBH
iPad Remote Control2016-12-30
FIAGON GMBH
MapperFrame2016-12-30
FIAGON GMBH
Fiagon Navigation Unit - Vision2016-12-30
Fiagon GmbH
Fiagon Navigation System2016-12-01
FIAGON GMBH
GuideWire 0.6 Single Use2016-08-09
FIAGON GMBH
GuideWire 0.62016-08-09
FIAGON GMBH
ShuntPointer2016-08-09
FIAGON GMBH
RegistrationPointer Cranial2016-08-09
FIAGON GMBH
Navigation sensor skull clamp2016-08-09
FIAGON GMBH
Localizer Adhesive Pad Cranial2016-08-09
FIAGON GMBH
FlexPointer Cranial2016-08-09
FIAGON GMBH
FlexPointer 1.5 mm Cranial2016-08-09
FIAGON GMBH
FinePointer Cranial2016-08-09
FIAGON GMBH
Fiagon Navigation Unit - Cranial2016-08-09
FIAGON GMBH
BiopsyPointer 2502016-08-09
FIAGON GMBH
BiopsyPointer 1902016-08-09
FIAGON GMBH
Fiagon Navigation System2016-04-01
FIAGON GMBH
PointerShell Universal, PointerShell LS2016-03-23
FIAGON GMBH
GuideWire2016-03-10
FIAGON GMBH
FlexPointer 1.52015-12-11
FIAGON GMBH
FlexPointer 1.5 Mm2015-04-16
FIAGON GMBH
RegistrationPointer2014-12-03
FIAGON GMBH
PointerTube Straight2014-12-03
FIAGON GMBH
PointerTube Stammberger2014-12-03
FIAGON GMBH
PointerTube Sinus Frontalis2014-12-03
FIAGON GMBH
PointerShell 5 mm2014-12-03
FIAGON GMBH
PointerShell 4 mm2014-12-03
FIAGON GMBH
PointerShell 3 mm2014-12-03
FIAGON GMBH
GuideWire2014-12-03
FIAGON GMBH
FlexTube 4 mm2014-12-03
FIAGON GMBH
FlexTube 3 mm2014-12-03
FIAGON GMBH
Fiagon Navigation ? Extended Instrument Set ENT2014-12-03
FIAGON GMBH
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL2014-10-08
FIAGON GMBH
Localizer Adhesive pad C-Type2014-05-13
FIAGON GMBH
FlexPointer2014-05-13
FIAGON GMBH
FinePointer2014-05-13
FIAGON GMBH
Fiagon Navigation System2014-05-13
FIAGON GMBH
FIAGON NAVIGATION SYSTEM2014-04-30

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