FDA.reportPublic FDA data

ENT stereotactic surgery system

Definition
An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during ear/nose/throat (ENT) surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
GUDID devices
95
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000457006Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-10
00763000457013Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-10
00763000457020Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-10
00763000457037Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-10
00763000457044Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-10
00763000457051Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-10
20613994696209N/AMEDTRONIC NAVIGATION, INC.97340002019-08-24
EFIAE0131041FlexTube 3 single useFiagon GmbH12021-06-11
00763000166601N/AMEDTRONIC NAVIGATION, INC.97339082020-06-12
04260759930126VirtuEyeFiagon GmbHE0114302024-09-02
00763000768744StealthStation S8MEDTRONIC NAVIGATION, INC.97357362023-11-27
00763000769017StealthStation S8MEDTRONIC NAVIGATION, INC.97359202023-11-27
00885556856840Ascension MCP Joint ReplacementSmith & Nephew, Inc.MCP-DIS-STR2023-08-02
00885556857656NuGrip CMCSmith & Nephew, Inc.CMC-DIS-HAL2023-08-02
00885556858479PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.PIP-DIS-HAL2023-08-02
10885862625823TruliantExactech, Inc.SPI-0021272023-03-27
00763000497958N/AMEDTRONIC NAVIGATION, INC.960-3612022-05-12
00763000547110LandmarXMEDTRONIC NAVIGATION, INC.9603612022-05-12
00763000531188SteathStationMEDTRONIC NAVIGATION, INC.97357362022-01-29
00763000531836SteathStationMEDTRONIC NAVIGATION, INC.97359202022-01-29
EFIAE0114301VirtuEyeFiagon GmbHv22022-01-10
EFIAE0114201VirtuEye V1Fiagon GmbH12021-06-11
EFIAE0130041FlexPointer 1.5 single useFiagon GmbH12021-06-11
EFIAE0131042FlexTube 3 single useFiagon GmbH12021-06-11
00763000456993Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357362021-04-03
00763000457563StealthStationMEDTRONIC NAVIGATION, INC.97359202021-04-03
00763000377199StealthStationMEDTRONIC NAVIGATION, INC.97359202021-03-13
00763000376215StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362020-08-31
04046964566325AESCULAPAESCULAP, INC.MA433R2020-05-08
00763000166618StealthStationMEDTRONIC NAVIGATION, INC.97360942019-02-10
00763000257903eNV®MEDTRONIC NAVIGATION, INC.960-3612019-10-19
00643169843929NAMEDTRONIC NAVIGATION, INC.97357422019-07-04
00763000238742StealthStationMEDTRONIC NAVIGATION, INC.97359202019-05-20
00763000238810StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362019-03-21
00885074036113NAMEDTRONIC NAVIGATION, INC.97312182016-09-19
00885074098579NAMEDTRONIC NAVIGATION, INC.97312172016-09-19
00885074098586NAMEDTRONIC NAVIGATION, INC.97312382016-09-19
00885074517261N/AMEDTRONIC NAVIGATION, INC.9732374XOM2016-06-18
00885074517490eNV™MEDTRONIC NAVIGATION, INC.9731249XOM2016-06-18
00763000031480FUSION™MEDTRONIC NAVIGATION, INC.9733560R2017-10-26
00763000064730StealthStationMEDTRONIC NAVIGATION, INC.97359202018-02-04
00763000071325StealthStationMEDTRONIC NAVIGATION, INC.97360942018-09-20
00763000075019StealthStationMEDTRONIC NAVIGATION, INC.97359202018-02-04
00763000075064StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-02-09
00763000075071StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-02-09
00763000075088StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-02-09
00763000075095StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-02-09
00763000075101StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-02-09
00763000075118StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-02-09
00763000075217StealthStationMEDTRONIC NAVIGATION, INC.97359202017-12-25
00763000075309StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362017-12-25
00763000075637StealthStationMEDTRONIC NAVIGATION, INC.97359202018-02-13
00763000075644StealthStationMEDTRONIC NAVIGATION, INC.97359202018-02-13
00763000075651StealthStationMEDTRONIC NAVIGATION, INC.97359202018-02-13
00763000075668StealthStationMEDTRONIC NAVIGATION, INC.97359202018-02-13
00763000116996StealthStation Cranial SoftwareMEDTRONIC NAVIGATION, INC.97357362018-08-02
00763000125066StealthStationMEDTRONIC NAVIGATION, INC.97359202018-06-29
00763000125202StealthStationMEDTRONIC NAVIGATION, INC.97357362018-07-08
00763000235079Fusion™ ENT Image Guidance SystemMEDTRONIC NAVIGATION, INC.97335602019-01-24
00721902321504eNV®MEDTRONIC NAVIGATION, INC.960-3612016-06-03
00721902966484FrameLink™MEDTRONIC NAVIGATION, INC.97311272016-09-19
00681490603829N/AMEDTRONIC NAVIGATION, INC.9603612016-06-03
00643169341548N/AMEDTRONIC NAVIGATION, INC.97318032016-06-20
00643169491748N/AMEDTRONIC NAVIGATION, INC.97334672016-06-13
00643169491762N/AMEDTRONIC NAVIGATION, INC.9733652XOM2016-06-13
00643169491779N/AMEDTRONIC NAVIGATION, INC.97336522016-06-13
00643169491786N/AMEDTRONIC NAVIGATION, INC.97336522016-06-13
00643169491793N/AMEDTRONIC NAVIGATION, INC.97336522016-06-13
00643169491809N/AMEDTRONIC NAVIGATION, INC.97336522016-06-13
00643169491816N/AMEDTRONIC NAVIGATION, INC.97336522016-06-13
00643169491823N/AMEDTRONIC NAVIGATION, INC.97336522016-06-13
00643169492226N/AMEDTRONIC NAVIGATION, INC.9733652XOM2016-06-13
00643169492233N/AMEDTRONIC NAVIGATION, INC.9733652XOM2016-06-13
00643169492240N/AMEDTRONIC NAVIGATION, INC.9733652XOM2016-06-13
00643169492257N/AMEDTRONIC NAVIGATION, INC.9733652XOM2016-06-13
00643169492264N/AMEDTRONIC NAVIGATION, INC.9733652XOM2016-06-13
00643169504394Fusion™ ENT Image Guidance SystemMEDTRONIC NAVIGATION, INC.97335602016-06-13
00643169518452Fusion™ ENT Image Guidance SystemMEDTRONIC NAVIGATION, INC.9733560XOM2016-06-13
00643169647121FUSION Compact ™MEDTRONIC NAVIGATION, INC.97355502016-12-10
00643169672956FUSION Compact ™MEDTRONIC NAVIGATION, INC.97356022016-12-11