FDA.reportPublic FDA data

Electromagnetic surgical navigation device tracking system

Definition
An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments typically with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/localizers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].
GUDID devices
174
Last updated
2023-05-16 06:36:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20841436118082eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.610-12542023-05-08
10884450433987SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504339802023-02-28
10884450450588SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504505812023-02-28
15420045515284Acessa ProVu SystemHologic, Inc.52002022-11-08
20884450500549SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505005452022-11-04
20841436121433VirtuTRAX Instrument NavigatorCIVCO MEDICAL INSTRUMENTS CO., INC.620-1272022-10-28
10884450564940SCOUT Bx™Merit Medical Systems, Inc.008844505649432022-08-31
10884450500627SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505006202022-05-07
10884450500597SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505005902022-05-03
10884450530242SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505302452022-04-22
10884521747425superDimensionCovidien LPPMB00667-012018-02-28
10884521747432superDimensionCovidien LPPMB00569-012018-02-28
10884450508142SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505081452022-03-17
10884450433956SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504339592022-02-24
20884450434899SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504348952022-02-24
20884450434943SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504349492022-02-24
10884521199989superDimensionCovidien LPAAS00161-202016-09-24
10884450434731SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347342022-02-15
00841436120234Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.676-2202021-11-20
00841436120241Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.115085882021-11-20
04250337116530Joimax® Intracs® EM System Integrated Navigation Tracking & Control SystemJoimax GmbHJINT01S2021-11-12
04250337116547Joimax® Intracs® EM Panel PCJoimax GmbHJINTPC11052021-11-12
04250337116554Joimax® Intracs® EM Control UnitJoimax GmbHJINTCU11152021-11-12
04250337116561Joimax® Intracs® EM Field GeneratorJoimax GmbHJINTFG11252021-11-12
04250337116585Joimax® Intracs® EM Patient TrackerJoimax GmbHJINTPT22352021-11-12
04250337116592Joimax® Intracs® EM Sensor ClipJoimax GmbHJINTSC22052021-11-12
04250337116608Joimax® Intracs® EM Sensor Wire 150Joimax GmbHJINTSW22152021-11-12
04250337116615Joimax® Intracs® EM Sensor Wire 180Joimax GmbHJINTSW22182021-11-12
04250337116622Joimax® Intracs® EM Sensor Wire 230Joimax GmbHJINTSW22232021-11-12
04250337116646Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clampJoimax GmbHJINTMA11352021-11-12
04250337117667Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clampJoimax GmbHJINTMAP11362021-11-12
04250337117988Wire cutterJoimax GmbHJINTWC2021-11-12
04250337117995Joimax® Intracs® EM Y-Adapter Joimax GmbHJINTYA352021-11-12
04250337118008Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mmJoimax GmbHJINTDG1828602021-11-12
04250337118015K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mmJoimax GmbHJKW15152021-11-12
04250337118213Joimax® Intracs® EM Patient Mapper - APJoimax GmbHJINTPM2245-AP2021-11-12
04250337118220Joimax® Intracs® EM Patient Mapper - LATJoimax GmbHJINTPM2245-LAT2021-11-12
20884450500600SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505006062021-11-03
10884521747418superDimensionCovidien LPILS-0001-FN2018-02-28
10884450464462SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504644652020-06-10
10884450434465SCOUT CHECK®MERIT MEDICAL SYSTEMS, INC.008844504344682021-09-24
10884521812383ILLUMISITECovidien LPILS-1000-CS2021-09-09
00841436101868eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-10572017-08-29
00841436102438eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1213-102017-08-29
00841436102537eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1217-102017-08-29
00841436103282eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1413-102017-08-29
00841436103305eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1417-102017-08-29
00841436103398eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1613-102017-08-29
00841436103411eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1615-102017-08-29
00841436103534eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1815-102017-08-29
00841436103558eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1818-102017-08-29
10884450434960SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504349632021-08-04
00843152104000IOPS™ Software ApplicationCenterline Biomedical, Inc.SW-12020-09-18
10884450530228SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505302212021-07-02
20884450530218SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505302142021-07-01
20884450530201SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505302072021-06-28
20841436118327Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0632021-06-23
20884450435032SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504350382021-06-14
10884450500573SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505005762021-05-12
10884450500351SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505003542021-04-26
20884450434875SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504348712021-04-15
20884450434912SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504349182021-04-15
10884450434984SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504349872021-03-11
00841436118811Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.657-0742021-01-22
00841436118828Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0752021-01-22
00841436119948Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.657-0762021-01-22
00841436119955Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0772021-01-22
00841436119986Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.657-0822021-01-22
00841436119993Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0832021-01-22
00841436120166Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.657-0842021-01-22
00841436120173Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.657-0852021-01-22
20884450434769SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347652021-01-19
20884450434783SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347892021-01-19
20884450434790SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347962021-01-19
05415067032195EnSite™ST. JUDE MEDICAL, INC.ENSITE-FF-012021-01-06
05415067032201EnSite™ST. JUDE MEDICAL, INC.ENSITE-R-FF-012021-01-06
07613327512298N / AStryker Leibinger GmbH & Co. KG80000600212020-12-04
07613327512304N / AStryker Leibinger GmbH & Co. KG80000600202020-11-26
00884838090668Onvision systemPhilips Medical Systems Nederland B.V.Onvision system2020-08-07
05415067024732EnSite Precision™ST. JUDE MEDICAL, INC.H7024732020-07-22