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.
| Registration Number | 3010313588 | ||||||
| FEI Number | 3010313588 | ||||||
| Name | FIAGON GMBH | ||||||
| Owner & Operator | fiagon GmbH | ||||||
| Contact Address | Neuendorfstr. 23b Hennigsdorf DE-BB Brandenburg 16761 DE | ||||||
| Official Correspondent |
| ||||||
| US Agent |
| ||||||
| Importing Logistics Registration |
| ||||||
| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | Neuendorfstr. 23b Hennigsdorf Brandenburg, 16761 DE | ||||||
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| Fiagon GmbH | VenSure 4D Balloon Dilation System E 01 3566 | 2025-09-26 |
| Fiagon GmbH | Integrated Headrest | 2025-07-03 |
| Fiagon GmbH | Adhesive Pad E003001 | 2024-09-10 |
| Fiagon GmbH | PointerShell Universal E012904 | 2024-09-10 |
| Fiagon GmbH | PointerShell 3 mm E012902 | 2024-09-10 |
| Fiagon GmbH | PointerShell 5 mm E012901 | 2024-09-10 |
| Fiagon GmbH | PointerShell 4 mm E012900 | 2024-09-10 |
| Fiagon GmbH | Navigation Headrest Universal E011003 | 2024-09-10 |
| Fiagon GmbH | VirtuEye E011430 | 2024-09-10 |
| Fiagon GmbH | RegistrationPointer E012003 | 2024-09-10 |
| Fiagon GmbH | RIWOtrack Cube4D E011106-HD/8 RW | 2024-01-15 |
| Fiagon GmbH | RIWOtrack Clipsensor N012951 | 2024-01-15 |
| Fiagon GmbH | RIWOtrack Flexsensor N012950 | 2024-01-15 |
| Fiagon GmbH | Adapter for Clipsensor N011959 | 2024-01-15 |
| Fiagon GmbH | Adapter for Flexsensor N011949 | 2024-01-15 |
| Fiagon GmbH | RIWOtrack Cube4D E011106-4K/8 RW | 2024-01-15 |
| Fiagon GmbH | MultiPad A011406-RW | 2024-01-15 |
| Fiagon GmbH | MapperBridge N012701-RW | 2024-01-15 |
| Fiagon GmbH | Localizer K-Wire N012213-RW | 2024-01-15 |
| Fiagon GmbH | Navigation Sensor Flexarm N011012 | 2024-01-15 |
| Fiagon GmbH | VenSure Balloon Dilation System E 01 3526 | 2022-11-18 |
| Fiagon GmbH | VenSure Nav Balloon Dilation System E 01 3546 | 2022-11-18 |
| Fiagon GmbH | VirtuEye E 01 1430 | 2022-01-18 |
Fiagon GmbH | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | 2021-07-19 |
| Fiagon GmbH | VenSure Nav Balloon Sinus Dilation System | 2021-06-21 |
| Fiagon GmbH | VenSure Balloon Sinus Dilation System E 01 3506 | 2021-06-21 |
| Fiagon GmbH | FlexTube 3 single use | 2021-06-21 |
| Fiagon GmbH | FlexPointer 1.5 single use E 01 3004 | 2021-06-21 |
| Fiagon GmbH | VirtuEye V1 E 01 1420 | 2021-06-21 |
Fiagon GmbH | VenSure Balloon Device, VenSure Nav Balloon Device | 2020-08-26 |
| 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 Use | 2020-03-27 |
FIAGON GMBH | FlexPointer 1.5 Single Use | 2020-03-27 |
Fiagon GmbH | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | 2020-03-10 |
| 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 | ShuntPointer | 2017-12-18 |
FIAGON GMBH | Navigation Unit | 2017-12-18 |
FIAGON GMBH | Localizer Bone Anchor | 2017-12-18 |
FIAGON GMBH | Localizer Adhesive Pad | 2017-12-18 |
FIAGON GMBH | BiopsyPointer 250 | 2017-12-18 |
FIAGON GMBH | BiopsyPointer 190 | 2017-12-18 |
FIAGON GMBH | Fiagon Navigation System | 2017-09-14 |
FIAGON GMBH | PointerTube Kennedy | 2017-04-19 |
FIAGON GMBH | PointerTube Keat | 2017-04-19 |
FIAGON GMBH | GuideWire 0.6 Single Use | 2017-02-22 |
FIAGON GMBH | Fiagon Navigation – PointerTube Straight And PointerTube Keat | 2017-02-16 |
FIAGON GMBH | iPad Remote Control | 2016-12-30 |
FIAGON GMBH | MapperFrame | 2016-12-30 |
FIAGON GMBH | Fiagon Navigation Unit - Vision | 2016-12-30 |
Fiagon GmbH | Fiagon Navigation System | 2016-12-01 |
FIAGON GMBH | GuideWire 0.6 Single Use | 2016-08-09 |
FIAGON GMBH | GuideWire 0.6 | 2016-08-09 |
FIAGON GMBH | ShuntPointer | 2016-08-09 |
FIAGON GMBH | RegistrationPointer Cranial | 2016-08-09 |
FIAGON GMBH | Navigation sensor skull clamp | 2016-08-09 |
FIAGON GMBH | Localizer Adhesive Pad Cranial | 2016-08-09 |
FIAGON GMBH | FlexPointer Cranial | 2016-08-09 |
FIAGON GMBH | FlexPointer 1.5 mm Cranial | 2016-08-09 |
FIAGON GMBH | FinePointer Cranial | 2016-08-09 |
FIAGON GMBH | Fiagon Navigation Unit - Cranial | 2016-08-09 |
FIAGON GMBH | BiopsyPointer 250 | 2016-08-09 |
FIAGON GMBH | BiopsyPointer 190 | 2016-08-09 |
FIAGON GMBH | Fiagon Navigation System | 2016-04-01 |
FIAGON GMBH | PointerShell Universal, PointerShell LS | 2016-03-23 |
FIAGON GMBH | GuideWire | 2016-03-10 |
FIAGON GMBH | FlexPointer 1.5 | 2015-12-11 |
FIAGON GMBH | FlexPointer 1.5 Mm | 2015-04-16 |
FIAGON GMBH | RegistrationPointer | 2014-12-03 |
FIAGON GMBH | PointerTube Straight | 2014-12-03 |
FIAGON GMBH | PointerTube Stammberger | 2014-12-03 |
FIAGON GMBH | PointerTube Sinus Frontalis | 2014-12-03 |
FIAGON GMBH | PointerShell 5 mm | 2014-12-03 |
FIAGON GMBH | PointerShell 4 mm | 2014-12-03 |
FIAGON GMBH | PointerShell 3 mm | 2014-12-03 |
FIAGON GMBH | GuideWire | 2014-12-03 |
FIAGON GMBH | FlexTube 4 mm | 2014-12-03 |
FIAGON GMBH | FlexTube 3 mm | 2014-12-03 |
FIAGON GMBH | Fiagon Navigation ? Extended Instrument Set ENT | 2014-12-03 |
FIAGON GMBH | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL | 2014-10-08 |
FIAGON GMBH | Localizer Adhesive pad C-Type | 2014-05-13 |
FIAGON GMBH | FlexPointer | 2014-05-13 |
FIAGON GMBH | FinePointer | 2014-05-13 |
FIAGON GMBH | Fiagon Navigation System | 2014-05-13 |
FIAGON GMBH | FIAGON NAVIGATION SYSTEM | 2014-04-30 |