Data / Medical devices / Neurosurgical Laser With Mr Thermography
Neurosurgical Laser With Mr Thermography (ONO): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Neurosurgical Laser With Mr Thermography (product code ONO, Class 2, 21 CFR 878.4810). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on September 3, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ONO
- Device class
- 2
- Regulation
- 878.4810
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Sweden | 1 |
Makers of Neurosurgical Laser With Mr Thermography
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer, Specification developer | 3 | March 13, 2026 | 0 | 1 | 0 | api.fda.gov |
| Clinical Laserthermia Systems AB | Lund Skane, Sweden | Complaint file establishment, Manufacturer | 2 | September 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Complaint file establishment, Manufacturer | 2 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Monteris Medical Corp | Minnetonka, MN, United States | Complaint file establishment, Manufacturer | 1 | June 4, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.