A mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures, commonly with respect to pre-acquired images and/or
| Company | Devices | Share |
|---|---|---|
| Brainlab Se | 85 | 68% |
| Ortoma Ab (Publ) | 23 | 18% |
| Stryker Leibinger Gmbh & Co. Kg | 8 | 6% |
| Acclarent, Inc. | 6 | 5% |
| Biosense Webster (Israel) Ltd. | 2 | 2% |
| Scopis Gmbh | 1 | 1% |
Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 70 |
| HAW | Neurological Stereotaxic Instrument | 48 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 17 |
| PGW | Ear, Nose, and Throat Stereotaxic Instrument | 13 |
| HAW | Neurological stereotaxic Instrument | 3 |
| SBF | Orthopedic Augmented Reality | 2 |
Use these as the dimensions to specify in a tender line.
125 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electromagnetic/optical surgical navigation/tracking system", from 6 companies. The largest labeler is Brainlab Se with 68% of records.
OLO (Orthopedic Stereotaxic Instrument), HAW (Neurological Stereotaxic Instrument), PGW (Ear, Nose, And Throat Stereotaxic Instrument), PGW (Ear, Nose, and Throat Stereotaxic Instrument)
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.