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Sign in to claim this brandMONTERIS MEDICAL CORP
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 131 Cheshire Lane, Suite 100, Minnetonka, MN, 55305
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009970070
- DUNS Number
- —
Catalogue (182)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FullFire® Diffusing Tip Laser Probe | 20414-4 | FDA UDI | Class II | Unknown |
| SideFire® Directional Laser Probe | 20368-00 | FDA UDI | Class II | Unknown |
| Mini-Bolt System | 29008 | FDA UDI | Class I | Active |
| SideFire® Directional Laser Probe | 20368-00 | FDA UDI | Class II | Unknown |
| Mini-Bolt System | 21239 | FDA UDI | Class I | Active |
| Mini-Bolt System | 20813 | FDA UDI | Class I | Active |
| AtamA™ System | 20800 | FDA UDI | Class II | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-000 | FDA UDI | Class II | Unknown |
| Fiducial Marker, Sterile | 21251 | FDA UDI | Class I | Active |
| Mini-Bolt System | 21061 | FDA UDI | Class I | Active |
| NeuroBlate Optic FullFire® Laser Probe | 20893-2 | FDA UDI | Class II | Active |
| Monteris Medical Ufo | K090240 | FDA 510(k) | Class II | Active |
| Monteris Medical Autolitt Laser Probe | K081509 | FDA 510(k) | Class II | Active |
| Monteris Medical NeuroBlate System | K240877 | FDA 510(k) | Class II | Active |
| Neuroblate System | K120561 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K172881 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K231061 | FDA 510(k) | Class II | Active |
| Monteris Medical NeuroBlate System | K171255 | FDA 510(k) | Class II | Active |
| Atama System | K132444 | FDA 510(k) | Class II | Active |
| NeuroBlate Fusion-S Software V3.17 | K222983 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K170724 | FDA 510(k) | Class II | Active |
| Neuroblate(tm) System | K131955 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K182036 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K162762 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K193375 | FDA 510(k) | Class II | Active |
| Atama System | K110411 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K260976 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K201056 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K173305 | FDA 510(k) | Class II | Active |
| Neuroblate System | K141983 | FDA 510(k) | Class II | Active |
| NeuroBlate System | K143457 | FDA 510(k) | Class II | Active |
| Monteris Medical Neuroblate System | K131278 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 5, 2017 | Z-0194-2018 | — | terminated | The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. |
| Mar 25, 2016 | Z-1614-2016 | — | terminated | Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain. |
| Oct 3, 2014 | Z-0228-2015 | — | terminated | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. |
| Oct 3, 2014 | Z-0227-2015 | — | terminated | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. |