FDA.reportPublic FDA data

Stereotactic surgery system probe, single-use

Definition
A long, sterile, slender, rod-like device made of metal and/or plastic, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a single-use device.
GUDID devices
102
Last updated
2022-01-07 08:22:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000588335AxiEM™MEDTRONIC NAVIGATION, INC.97335332021-12-30
00763000588342AxiEM™MEDTRONIC NAVIGATION, INC.9733533XOM2021-12-30
00763000588359AxiEM™MEDTRONIC NAVIGATION, INC.97335342021-12-30
00763000588366AxiEM™MEDTRONIC NAVIGATION, INC.9733534XOM2021-12-30
00763000588441AxiEM™MEDTRONIC NAVIGATION, INC.97353172021-12-30
00763000588458AxiEM™MEDTRONIC NAVIGATION, INC.97353182021-12-30
00763000588465AxiEM™MEDTRONIC NAVIGATION, INC.97353192021-12-30
00763000588489AxiEM™MEDTRONIC NAVIGATION, INC.97354282021-12-30
00763000581053N/AMEDTRONIC NAVIGATION, INC.97334522021-11-25
00763000564100N/AMEDTRONIC NAVIGATION, INC.97334522021-08-14
10603295520139VELYSDEPUY (IRELAND)4515-70-0122021-06-18
10603295520146VELYS PURESIGHTDEPUY (IRELAND)4515-70-0112021-06-18
10603295537984VELYSDEPUY (IRELAND)4515-70-2032021-06-18
00815212022920PAK NeedleIzi Medical Products, LLCMP60012021-05-24
00815212024320PAK Needle - 7DIzi Medical Products, LLCMP6001-7D2021-05-24
00643169555495Navigated NIM-SPINE®MEDTRONIC NAVIGATION, INC.97334972020-10-31
00763000423155N/AMEDTRONIC NAVIGATION, INC.97334522020-10-12
00643169702844N/AMEDTRONIC NAVIGATION, INC.97335342019-03-04
20613994320210AxiEM™MEDTRONIC NAVIGATION, INC.97334232016-10-01
20613994320227AxiEM™MEDTRONIC NAVIGATION, INC.97334242016-06-18
20643169632725AxiEM™MEDTRONIC NAVIGATION, INC.97334242018-09-03
90814277020035Pathfinder Shadow BK-TANALOGIC CORPORATION10-77322S-012016-09-17
90814277020042Pathfinder Shadow ANALOGIC CORPORATION10-77247S-012016-09-17
90814277020059Pathfinder Shadow (Aloka)ANALOGIC CORPORATION10-77246S-012016-09-17
90814277020066Pathfinder Small Multi-Tool Instrument ClampANALOGIC CORPORATION10-77260S-012016-09-17
90814277020073Pathfinder Large Multi-Tool Instrument ClampANALOGIC CORPORATION10-77249S-012016-09-17
90814277020080Pathfinder BeaconANALOGIC CORPORATION10-77248S-012016-09-17
90814277020097Pathfinder TracerANALOGIC CORPORATION10-77243S-012016-09-17
90814277020103Pathfinder Long ProbeANALOGIC CORPORATION10-77242S-012016-09-17
90814277020110Pathfinder Tracked ProbeANALOGIC CORPORATION10-77241S-012016-09-17
B169CYG10B2TP0Compass InternationalCompass InternationalCYG-10-B2TP2016-09-13
B169CYG10BTP0Compass InternationalCompass InternationalCYG-10-BTP2016-09-13
B169CYG10LPTP0Compass InternationalCompass InternationalCYG-10-LPTP2016-09-13
B169CYG10LSTP0Compass InternationalCompass InternationalCYG-10-LSTP2016-09-13
B169CYG10PTP0Compass InternationalCompass InternationalCYG-10-PTP2016-09-13
B169CYG10STP0Compass InternationalCompass InternationalCYG-10-STP2016-09-13
B169CYG14FSCT100Compass InternationalCompass InternationalCYG-14F-SCT102016-09-13
B169CYG4FCT100Compass InternationalCompass InternationalCYG-4F-CT102016-08-12
B169CYG4FCT10TP0Compass InternationalCompass InternationalCYG-4F-CT10TP2016-09-13
B169CYG5FNPT100Compass InternationalCompass InternationalCYG-5F-NPT102016-09-13
B169CYG5FNPT10TP0Compass InternationalCompass InternationalCYG-5F-NPT10TP2016-09-13
B169CYG9FSCT100Compass InternationalCompass InternationalCYG-9F-SCT102016-09-13
B169CYG9FSCT10TP0Compass InternationalCompass InternationalCYG-9F-SCT10TP2016-09-13
B169REG30BC0Compass InternationalCompass InternationalREG-30-BC2016-08-26
B169REG30BCENT0Compass InternationalCompass InternationalREG-30-BCENT2016-08-26
B169REG30D0Compass InternationalCompass InternationalREG-30-D2016-08-26
B169REGBCBAY0Compass InternationalCompass InternationalREG-BCBAY2016-08-26
07613252727019PROFESSStryker Leibinger GmbH & Co. KG6001-410-0002016-08-24
07613252727026PROFESSStryker Leibinger GmbH & Co. KG6001-410-0702016-08-24
07613252727033PROFESSStryker Leibinger GmbH & Co. KG6001-410-0902016-08-24
07613252727040PROFESSStryker Leibinger GmbH & Co. KG6001-410-1002016-08-24
00885074328225N/AMEDTRONIC NAVIGATION, INC.97321762016-06-18
00885556195284TRIGENSmith & Nephew, Inc.716911522015-08-25
00763000053369NAMEDTRONIC NAVIGATION, INC.97334492018-09-17
00763000053383N/AMEDTRONIC NAVIGATION, INC.97334512018-11-23
00763000053390N/AMEDTRONIC NAVIGATION, INC.97334502018-10-25
00763000053406N/AMEDTRONIC NAVIGATION, INC.97334482018-10-22
00763000053413N/AMEDTRONIC NAVIGATION, INC.97334472018-11-24
00763000053437N/AMEDTRONIC NAVIGATION, INC.97334462018-10-06
00763000083557N/AMEDTRONIC NAVIGATION, INC.9733534XOM2018-04-14
00763000083564N/AMEDTRONIC NAVIGATION, INC.9733533XOM2018-06-08
00763000138820N/AMEDTRONIC NAVIGATION, INC.97321762018-10-19
00763000213725N/AMEDTRONIC NAVIGATION, INC.97334522018-11-30
00763000231996N/AMEDTRONIC NAVIGATION, INC.97321762018-12-28
00643169358027N/AMEDTRONIC NAVIGATION, INC.97311152016-06-13
00643169425019AxiEM™MEDTRONIC NAVIGATION, INC.97336052016-06-13
00643169425026AxiEM™MEDTRONIC NAVIGATION, INC.97336062016-06-13
00643169490024Tracer PointerMEDTRONIC NAVIGATION, INC.97353172016-05-23
00643169490031N/AMEDTRONIC NAVIGATION, INC.97353182016-05-23
00643169490048N/AMEDTRONIC NAVIGATION, INC.97353192016-05-23
00643169490468N/AMEDTRONIC NAVIGATION, INC.97354282016-05-23
00643169632714N/AMEDTRONIC NAVIGATION, INC.97321762018-02-10
00643169702806N/AMEDTRONIC NAVIGATION, INC.97334462017-12-09
00643169702813NAMEDTRONIC NAVIGATION, INC.97334472018-09-29
00643169702820N/AMEDTRONIC NAVIGATION, INC.97334482018-10-25
00643169702837N/AMEDTRONIC NAVIGATION, INC.97335332018-10-25
00643169702851N/AMEDTRONIC NAVIGATION, INC.97334492017-12-07
00643169702868N/AMEDTRONIC NAVIGATION, INC.97334502017-11-25
00643169702875N/AMEDTRONIC NAVIGATION, INC.97334512018-03-16
00613994306777N/AMEDTRONIC NAVIGATION, INC.9733446XOM2016-05-27