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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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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
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- FDA FEI Number
- 3009970070
- DUNS Number
- —
Catalogue (182)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeuroBlate Optic SideFire® Laser Probe | 20891-5 | FDA UDI | Class II | Active |
| Mini-Bolt System | 22004 | FDA UDI | Class I | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-2 | FDA UDI | Class II | Unknown |
| FullFire® Diffusing Tip Laser Probe | 20414-5 | FDA UDI | Class II | Unknown |
| Mini-Bolt System | 20693 | FDA UDI | Class I | Active |
| Mini-Bolt System | 20812 | FDA UDI | Class I | Active |
| Mini-Bolt System | 20820 | FDA UDI | Class I | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-2 | FDA UDI | Class II | Active |
| FullFire® Diffusing Tip Laser Probe | 20414-000 | FDA UDI | Class II | Unknown |
| AtamA™ System | 20763 | FDA UDI | Class II | Active |
| SideFire® Directional Laser Probe | 20368-1 | FDA UDI | Class II | Unknown |
| FullFire® Diffusing Tip Laser Probe | 20414-5 | FDA UDI | Class II | Active |
| SideFire® Directional Laser Probe | 20368-1 | FDA UDI | Class II | Unknown |
| SideFire® Directional Laser Probe | 20368-000 | FDA UDI | Class II | Unknown |
| SideFire® Directional Laser Probe | 20368-3 | FDA UDI | Class II | Unknown |
| FullFire® Select Diffusing Tip Laser Probe | 20624-1 | FDA UDI | Class II | Unknown |
| NeuroBlate Optic SideFire® Laser Probe | 20891-3 | FDA UDI | Class II | Active |
| Mini-Bolt System | 21154 | FDA UDI | Class I | Active |
| NeuroBlate Optic FullFire® Laser Probe | 20895-000 | FDA UDI | Class II | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-2 | FDA UDI | Class II | Unknown |
| NeuroBlate Optic FullFire® Laser Probe | 20895-4 | FDA UDI | Class II | Active |
| FullFire® Diffusing Tip Laser Probe | 20414-000 | FDA UDI | Class II | Unknown |
| NeuroBlate Optic FullFire® Laser Probe | 20895-1 | FDA UDI | Class II | Active |
| AtamA™ System | 20758 | FDA UDI | Class II | Active |
| Mini-Bolt System | 21228 | FDA UDI | Class I | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-1 | FDA UDI | Class II | Unknown |
| Mini-Bolt System | 20627 | FDA UDI | Class I | Active |
| Mini-Bolt System | 20659 | FDA UDI | Class I | Active |
| Mini-Bolt Cap | 21117 | FDA UDI | Class I | Active |
| AtamA™ System | 20607 | FDA UDI | Class II | Active |
| Mini-Bolt System | 20626 | FDA UDI | Class I | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-5 | FDA UDI | Class II | Unknown |
| Mini-Bolt System | 20725 | FDA UDI | Class I | Active |
| Mini-Bolt System | 21153 | FDA UDI | Class I | Active |
| AtamA™ System | 20615 | FDA UDI | Class II | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-00 | FDA UDI | Class II | Unknown |
| AtamA™ System | 20762 | FDA UDI | Class II | Active |
| NeuroBlate Optic FullFire® Laser Probe | 20893-3 | FDA UDI | Class II | Active |
| FullFire® Select Diffusing Tip Laser Probe | 20624-3 | FDA UDI | Class II | Unknown |
| FullFire® Diffusing Tip Laser Probe | 20414-000 | FDA UDI | Class II | Unknown |
| FullFire® Select Diffusing Tip Laser Probe | 20624-3 | FDA UDI | Class II | Unknown |
| SideFire® Directional Laser Probe | 20368-3 | FDA UDI | Class II | Unknown |
| NeuroBlate Optic SideFire® Laser Probe | 20891-1 | FDA UDI | Class II | Active |
| AtamA™ System | 20609 | FDA UDI | Class II | Active |
| Mini-Bolt System | 21209 | FDA UDI | Class I | Active |
| FullFire® Diffusing Tip Laser Probe | 20414-2 | FDA UDI | Class II | Unknown |
| AtamA™ System | 20550 | FDA UDI | Class II | Active |
| FullFire® Diffusing Tip Laser Probe | 20414-3 | FDA UDI | Class II | Unknown |
| SideFire® Directional Laser Probe | 20368-2 | FDA UDI | Class II | Unknown |
| FullFire® Select Diffusing Tip Laser Probe | 20624-5 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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. |