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
59
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
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
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
10884450434731SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347342022-02-15
20884450500600SCOUT®MERIT MEDICAL SYSTEMS, INC.008844505006062021-11-03
10884450464462SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504644652020-06-10
10884450434465SCOUT CHECK®MERIT MEDICAL SYSTEMS, INC.008844504344682021-09-24
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
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
20884450434769SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347652021-01-19
20884450434783SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347892021-01-19
20884450434790SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504347962021-01-19
10884450493318SCOUT®Merit Medical Systems, Inc.008844504933112020-07-20
10884450493325SCOUT®Merit Medical Systems, Inc.008844504933282020-07-20
10884450435868SCOUT®Merit Medical Systems, Inc.008844504358612020-06-29
00841436100977eTRAX™ Needle SensorCIVCO MEDICAL INSTRUMENTS CO., INC.54081342017-08-22
00841436101127eTRAX™ Needle SensorCIVCO MEDICAL INSTRUMENTS CO., INC.54951922017-08-22
00841436101134eTRAX™ Needle SensorCIVCO MEDICAL INSTRUMENTS CO., INC.54951932017-08-22
00841436101141eTRAX™ Needle SensorCIVCO MEDICAL INSTRUMENTS CO., INC.54951942017-08-22
00841436102520eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1217-012017-08-28
00841436103299eTRAX™ NeedleCIVCO MEDICAL INSTRUMENTS CO., INC.610-1417-012017-08-28
10884450433895SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504338982019-12-04
10884450435011SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504350142019-11-27
10884450435837SCOUT®Merit Medical Systems, Inc.008844504358302019-11-27
10884450435851SCOUT®Merit Medical Systems, Inc.008844504358542019-11-27
10852205006106SCOUT®MERIT MEDICAL SYSTEMS, INC.008522050061092019-11-13
10884450434816SCOUT®MERIT MEDICAL SYSTEMS, INC.008844504348192019-11-12
07613327413236TGS NavigationStryker Leibinger GmbH & Co. KG8000-010-0042018-08-08
07613327413274n/aStryker Leibinger GmbH & Co. KG8000-100-0012018-08-08
10815686020436Always-On Trip Tracked Guidewire, 1.0mm, 735mmVERAN MEDICAL TECHNOLOGIES INC.INS-03042016-08-31
10815686020443Always-On Tip Tracked Guidewire, 1.0mm, 950mmVERAN MEDICAL TECHNOLOGIES INC.INS-03052016-08-31