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Sign in to claim this brandNEURALYNX, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 105 Commercial Dr, Bozeman, MT, 59715
- Website
- neuralynx.com
- —
- —
- [email protected]
- Phone
- 406-585-4542
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009391672
- DUNS Number
- 933200842
Catalogue (107)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ATLAS Patient Event Marker | ATLAS Patient Event Marker | FDA UDI | Class II | Active |
| Atlas Hc Headbox | ATLAS HC HEADBOX | FDA UDI | Class II | Active |
| Global Reference Module 8 | Global Reference Module - 8 | FDA UDI | Class II | Active |
| Global Reference Module 1 | Global Reference Module - 1 | FDA UDI | Class II | Active |
| ATLAS Stim Headbox Software | 1.5.1 | FDA UDI | Class II | Unknown |
| Atlas Headbox | ATLAS HEADBOX | FDA UDI | Class II | Active |
| Global Reference Module 5 | Global Reference Module - 5 | FDA UDI | Class II | Active |
| Zipshield 8m | 8m | FDA UDI | Class II | Active |
| Atlas-Hs-36-Chet-A9 | ATLAS-HS-36-CHET-A9 | FDA UDI | Class II | Active |
| Teth-Xtn-Mm-2 | EXTENSION CABLE: TETH-XTN-2 Meter | FDA UDI | Class II | Active |
| ATLAS Workstation Monitor | ATLAS Workstation Monitor | FDA UDI | Class II | Active |
| High Density Junction Box - F | -F | FDA UDI | Class II | Active |
| High Density Tether 2m | 2m | FDA UDI | Class II | Active |
| Pegasus Software License 352ch | 352 Channel | FDA UDI | Class II | Active |
| High Density Junction Box - H | -H | FDA UDI | Class II | Active |
| Atlas Nk Headbox | ATLAS NK HEADBOX | FDA UDI | Class II | Active |
| ATLAS Parallel TTL Cable | ATLAS Parallel TTL Cable | FDA UDI | Class II | Active |
| ATLAS TPSS Cable | ATLAS TPSS Cable | FDA UDI | Class II | Active |
| High Density Tether 3m | 3m | FDA UDI | Class II | Active |
| Ethernet Switch | Ethernet Switch | FDA UDI | Class II | Active |
| Global Reference Module 13 | Global Reference Module - 13 | FDA UDI | Class II | Active |
| ADPT-NKSS-DRS-BCD Adapter Cable | ADPT-NKSS-DRS-BCD Adapter Cable | FDA UDI | Class II | Active |
| High Density Tether 5.38 m | 5.38 m | FDA UDI | Class II | Active |
| Modular Electrode Interface-PM10 | MEI-PM10 | FDA UDI | Class II | Active |
| ATLAS Rackmounted Power Isolator | ATLAS Rackmounted Power Isolator | FDA UDI | Class II | Active |
| Pegasus Software License 128ch | 128 Channel | FDA UDI | Class II | Active |
| Atlas Hd Headbox | ATLAS HD HEADBOX | FDA UDI | Class II | Active |
| Global Reference Module 9 | Global Reference Module - 9 | FDA UDI | Class II | Active |
| ATLAS TOPHAT Adapter Cable | ATLAS TOPHAT Adapter Cable | FDA UDI | Class II | Unknown |
| ADPT-NKSS-Y-A Adapter Cable | ADPT-NKSS-Y-A Adapter Cable | FDA UDI | Class II | Unknown |
| ATLAS Stim Headbox - Touchproof | Touchproof | FDA UDI | Class II | Active |
| High Density Junction Box - B | -B | FDA UDI | Class II | Active |
| Global Reference Module 11 | Global Reference Module - 11 | FDA UDI | Class II | Active |
| High Density Tether 1m | 1m | FDA UDI | Class II | Active |
| High Density Junction Box - E | -E | FDA UDI | Class II | Active |
| Pegasus Software License 256ch | 256 Channel | FDA UDI | Class II | Active |
| Global Reference Module 15 | Global Reference Module - 15 | FDA UDI | Class II | Active |
| ATLAS Stim Headbox - High Density | High Density | FDA UDI | Class II | Active |
| Global Reference Module 6 | Global Reference Module - 6 | FDA UDI | Class II | Active |
| Global Reference Module 12 | Global Reference Module - 12 | FDA UDI | Class II | Active |
| ATLAS Ground Drive | Active Ground Drive | FDA UDI | Class II | Active |
| Teth-Xtn-Mm-5 | EXTENSION CABLE: TETH-XTN-5 Meter | FDA UDI | Class II | Active |
| Modular Electrode Interface-PM16 | MEI-PM16 | FDA UDI | Class II | Active |
| ADPT-NKSS-DRS-A AdapterCable | ADPT-NKSS-DRS-A AdapterCable | FDA UDI | Class II | Active |
| Pegasus Software License 384ch | 384 Channel | FDA UDI | Class II | Active |
| Global Reference Module 3 | Global Reference Module - 3 | FDA UDI | Class II | Active |
| Zipshield 5m | 5m | FDA UDI | Class II | Active |
| Pegasus Software License 224ch | 224 Channel | FDA UDI | Class II | Active |
| ATLAS Headbox Interface Cable - High Density | High Density | FDA UDI | Class II | Active |
| ATLAS Headbox Interface Cable - Touchproof | Touchproof | FDA UDI | Class II | Active |
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 (1)
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 |
|---|---|---|---|---|
| Mar 14, 2022 | Z-1091-2022 | — | open, classified | Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance. |