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Device Explorer · FDA GUDID · GMDN 58183

Electromagnetic surgical navigation/tracking system

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/orientati

US‑registered devices329in commercial distribution
Companies19labelers on GUDID
Single‑use40%of device records
Sterile36%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.12137%
Civco Medical Instruments Co., Inc.9629%
Joimax Gmbh206%
Stryker Leibinger Gmbh & Co. Kg175%
Covidien Lp175%
Scopis Gmbh93%
Halt Medical, Inc72%
St. Jude Medical, Inc.62%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.12137%
Civco Medical Instruments Co., Inc.9629%
Joimax Gmbh206%
Stryker Leibinger Gmbh & Co. Kg175%
Covidien Lp175%
Scopis Gmbh93%
Halt Medical, Inc72%
St. Jude Medical, Inc.62%
Karl Storz Gmbh & Co. Kg62%
Centerline Biomedical, Inc.62%
Imactis62%
Boston Scientific Corporation52%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N / An/aTGS NavigationEnSite™EnSite Precision™ Link, Sensor Enabled™EnSite Precision™Joimax® Intracs® EM Patient Mapper - LATJoimax® Intracs® EM Patient Mapper - APIntracs®K-Wire w/ thread, Trocar w. 15 mm thread, round Joimax® Intracs® EM K-Wire Drill Guide W 18 mm xJoimax® Intracs® EM Y-AdapterWire cutterJoimax® Intracs® EM Mounting Arm f. Patient MappJoimax® Intracs® EM Mounting Arm f field GeneratJoimax® Intracs® EM Sensor Wire 230

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NEUMARKER, RADIOGRAPHIC, IMPLANTABLE109
IYOSystem, imaging, pulsed echo, ultrasonic99
JAKSystem, X-Ray, Tomography, Computed40
PGWEar, Nose, and Throat Stereotaxic Instrument20
JAKSystem, x-ray, tomography, computed17
OLOOrthopedic Stereotaxic Instrument16

GMDN & GCC registration

  • GMDN code 58183 · non‑implantable
  • Single‑use 40% · sterile 36% · Rx‑only 85% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 60Needle Gauge (Gauge) · 33Width (Inch) · 25Length (Centimeter) · 19Height (Inch) · 15Width (Centimeter) · 4

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many electromagnetic surgical navigation/tracking system products are registered in the US?

329 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electromagnetic surgical navigation/tracking system", from 19 companies. The largest labeler is Merit Medical Systems, Inc. with 37% of records.

Which FDA product codes apply?

NEU (MARKER, RADIOGRAPHIC, IMPLANTABLE), IYO (System, imaging, pulsed echo, ultrasonic), JAK (System, X-Ray, Tomography, Computed), PGW (Ear, Nose, and Throat Stereotaxic Instrument)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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