FDA.reportPublic FDA data

Electromagnetic surgical navigation/tracking system

Definition
An assembly of devices intended for tracking spatial markers attached to a surgical instrument(s) and/or the patient, based on movement through a variable electromagnetic (EM) field. It is designed to generate visual diagrams of the relative position/orientation of the instrument/marker during surgery and may additionally allow surgical navigation through overlay of radiological images [e.g., ultrasound (US)]. It consists of a console with display and an EM field generator/receiver; spatial markers, instruments, a foot switch, or trolley may in addition be packaged with the system. It is intended for use during multiple types of surgical procedure (e.g., breast, gastrointestinal, lung).
GUDID devices
365
Last updated
2026-09-04 23:13:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00815686020064ig4 System V2, 120V, 60HzVERAN MEDICAL TECHNOLOGIES INC.SYS-20002016-08-31
00815686020071ig4 System V2, 230V, 50HzVERAN MEDICAL TECHNOLOGIES INC.SYS-22302016-08-31
00815686020088ig4 System, 120V, 60HzVERAN MEDICAL TECHNOLOGIES INC.SYS-30002016-08-31
00815686020095ig4 System, 230V, 50HzVERAN MEDICAL TECHNOLOGIES INC.SYS-32302016-08-31
00815686020101SPiN Thoracic Navigation System, 120V, 60HzVERAN MEDICAL TECHNOLOGIES INC.SYS-40002016-11-16
00815686020118SPiN Thoracic Navigation System, 230V, 50HzVERAN MEDICAL TECHNOLOGIES INC.SYS-42302016-11-16
0081568602023117ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50222016-08-31
0081568602024817ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50232016-08-31
0081568602025517ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50242016-08-31
0081568602026218ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50252016-08-31
0081568602027918ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50262016-08-31
0081568602028618ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50272016-08-31
0081568602029319 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50282016-08-31
0081568602030919 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50292016-08-31
0081568602031619 UTW, 45mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50302016-08-31
0081568602032319 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50312016-08-31
0081568602033019 UTW, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50322016-08-31
0081568602034719 UTW, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50332016-08-31
0081568602035417ga LG, 123mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50342016-08-31
0081568602036122 UTW, 125mm Always-On Tip Tracked Biopsy Needle, Trocar PointVERAN MEDICAL TECHNOLOGIES INC.INS-50362016-08-31
0081568602042221ga 600mm Always-On Tip Tracked Stylet, Blunt TipVERAN MEDICAL TECHNOLOGIES INC.INS-52002016-08-31
00815686020439Always-On Trip Tracked Guidewire, 1.0mm, 735mmVERAN MEDICAL TECHNOLOGIES INC.INS-03042016-08-31
00815686020446Always-On Tip Tracked Guidewire, 1.0mm, 950mmVERAN MEDICAL TECHNOLOGIES INC.INS-03052016-08-31
00815686020552Always-On Tip Tracked Forceps, 1.8mm OD Oval CupVERAN MEDICAL TECHNOLOGIES INC.INS-03622016-08-31
00815686020576Always-On Tip Tracked Forceps, 1.8mm OD, Serrated CupVERAN MEDICAL TECHNOLOGIES INC.INS-03722016-08-31
00815686020699Always-On vTrack Universal Tracker, SM/CL, 12-18gaVERAN MEDICAL TECHNOLOGIES INC.INS-50392016-08-31
00815686020705Always-On vTrack Universal Tracker, LG, 7-12gaVERAN MEDICAL TECHNOLOGIES INC.INS-50402016-08-31
0081568602080417ga, 45mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50182016-08-31
0081568602092717ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba PointVERAN MEDICAL TECHNOLOGIES INC.INS-50352016-08-31
00815686021061ig4IR Software ApplicationVERAN MEDICAL TECHNOLOGIES INC.SFT-00042016-08-31
00815686021139SPiN Perc Localization Needle 19ga x 105mm, 1cm marking zoneVERAN MEDICAL TECHNOLOGIES INC.INS-56102018-01-25
00815686021146SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zoneVERAN MEDICAL TECHNOLOGIES INC.INS-56112018-01-25
00841436100274Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104411832017-08-22
00841436100281Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104411842017-08-22
00841436100298Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104411872017-08-22
00841436100304Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104411882017-08-22
00841436100311Biopsy Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104411892017-08-22
00841436100328Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104411902017-08-22
00841436100342eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.104416282017-08-22
00841436100519eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.108543882017-08-22
00841436100526eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.108552262018-08-17
00841436100533eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.108552272018-08-17
00841436100885eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.53509242017-08-22
00841436100892VirtuTRAX Instrument NavigatorCIVCO MEDICAL INSTRUMENTS CO., INC.53509252017-08-22
00841436101073eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.54511172017-08-22
00841436101103eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.54835282017-08-22
00841436101110eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.54835442017-08-22
00841436101844eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-10552017-08-22
00841436101936VirtuTRAX Instrument NavigatorCIVCO MEDICAL INSTRUMENTS CO., INC.610-10802017-08-22
00841436102063eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-11122017-08-22
00841436102797eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-12542023-05-08
00841436103206eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-14012017-08-22
00841436103428eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-18012017-08-22
00841436103435eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-18022017-08-22
00841436105583Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0312017-08-22
00841436105651Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0382017-08-22
00841436105668Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0392017-08-22
00841436105675Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0402017-08-22
00841436105682Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0412017-08-22
00841436105699Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0422017-08-22
00841436105750Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0512017-08-22
00841436105767Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.639-0522017-08-22
00841436106184Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.657-0372017-08-22
00841436106191Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.657-0382017-08-22
00841436106214Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0402017-08-22
00841436106221Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0412017-08-22
00841436106818Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.667-1362017-08-22
00841436106825Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.667-1382017-08-22
00841436108805Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H40432LF2017-08-22
00841436108829Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H40432LK2017-08-22
00841436108904Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H40482LF2017-08-22
00841436108935Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H40482LM2017-08-22
00841436109123Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H46332LZ2017-08-22
00841436109314Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4908NB2017-08-22
00841436109321Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4908ND2017-08-22
00841436109338Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4908NF2017-08-22
00841436109345Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4908NH2017-08-22
00841436109352Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4908NM2017-08-22
00841436109369Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4908NN2017-08-22
00841436109383eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.H4910NT2017-08-22