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NEURALYNX, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
105 Commercial Dr, Bozeman, MT, 59715
Website
neuralynx.com
LinkedIn
—
Facebook
—
Phone
406-585-4542
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3009391672
DUNS Number
933200842

Catalogue (107)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
ATLAS Headbox Interface Cable - NK NK
FDA UDI
Class IIActive
Pegasus Software License 288ch 288 Channel
FDA UDI
Class IIActive
Pegasus Software License 480ch 480 Channel
FDA UDI
Class IIActive
Atlas Analog Isolator ATLAS ANALOG ISOLATOR
FDA UDI
Class IIActive
Teth-Xtn-Mm-1 EXTENSION CABLE: TETH-XTN-1 Meter
FDA UDI
Class IIActive
Global Reference Module 16 Global Reference Module - 16
FDA UDI
Class IIActive
Global Reference Module 7 Global Reference Module - 7
FDA UDI
Class IIActive
Atlas Hdss ATLAS HDSS
FDA UDI
Class IIActive
ATLAS Stim Headbox - NK NK
FDA UDI
Class IIActive
High Density Junction Box -A
FDA UDI
Class IIActive
Atlas-Hs-36-Chet-Tether ATLAS-HS-36-CHET-TETHER
FDA UDI
Class IIActive
ATLAS Headbox Expansion Panel ATLAS HEP
FDA UDI
Class IIActive
Atlas-Hs-36-Chet-D18 ATLAS-HS-36-CHET-D18
FDA UDI
Class IIActive
Atlas-Hs-18-Chet-A 1.0 1.0
FDA UDI
Class IIActive
Global Reference Module 2 Global Reference Module - 2
FDA UDI
Class IIActive
High Density Tether 5m High Density Tether 5m
FDA UDI
Class IIActive
Pegasus Software License 96ch 96 Channel
FDA UDI
Class IIActive
ATLAS Cart ATLAS Cart
FDA UDI
Class IIActive
ADPT-HD-Y Adapter Cable 31-0602-0033
FDA UDI
Class IIActive
Pegasus Software License 64ch 64 channel
FDA UDI
Class IIActive
Atlas-Hs-10-Chet-A 1.0 1.0
FDA UDI
Class IIActive
Fiber Optic Connector 2m 2m
FDA UDI
Class IIActive
ADPT-NKSS-Y-B Adapter Cable ADPT-NKSS-Y-B Adapter Cable
FDA UDI
Class IIUnknown
Global Reference Module 10 Global Reference Module - 10
FDA UDI
Class IIActive
ATLAS Workstation ATLAS Workstation
FDA UDI
Class IIActive
High Density Junction Box - G -G
FDA UDI
Class IIActive
Pegasus Software License 512ch 512 Channel
FDA UDI
Class IIActive
ATLAS Power Isolator 110VAC 110VAC
FDA UDI
Class IIActive
Atlas Micromed Jb Interface ATLAS MICROMED JB INTERFACE
FDA UDI
Class IIActive
Pegasus Software License 32ch 32 channel
FDA UDI
Class IIActive
Pegasus Software License 448ch 448 Channel
FDA UDI
Class IIActive
ATLAS Power Isolator 220VAC 220VAC
FDA UDI
Class IIActive
Atlas Combo Board ATLAS COMBO BOARD
FDA UDI
Class IIActive
Teth-Xtn-Mm-8 EXTENSION CABLE: TETH-XTN-8 Meter
FDA UDI
Class IIActive
High Density Junction Box - D -D
FDA UDI
Class IIActive
ATLAS Neurophysiology System ATLAS Neurophysiology System
FDA UDI
Class IIActive
Atlas Chet Adapter ATLAS CHET ADAPTER
FDA UDI
Class IIUnknown
Pegasus Software License 416ch 416 Channel
FDA UDI
Class IIActive
Global Reference Module 14 Global Reference Module - 14
FDA UDI
Class IIActive
Pegasus 2.3.1
FDA UDI
Class IIActive
ATLAS TTL Isolator ATLAS TTL Isolator
FDA UDI
Class IIActive
High Density Junction Box - C -C
FDA UDI
Class IIActive
Modular Headstage-36 Modular Headstage-36
FDA UDI
Class IIActive
Pegasus Software License 192ch 192 Channel
FDA UDI
Class IIActive
Tether Interconnect TETHER INTERCONNECT
FDA UDI
Class IIActive
ADPT-NKSS-Y-C Adapter Cable ADPT-NKSS-Y-C Adapter Cable
FDA UDI
Class IIUnknown
ATLAS Cart BNC Adapter Plate ATLAS Cart BNC Adapter Plate
FDA UDI
Class IIActive
Pegasus Software License 320ch 320 Channel
FDA UDI
Class IIActive
Pegasus Software License 160ch 160 Channel
FDA UDI
Class IIActive
NetCom Client 3.1.0
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Mar 14, 2022Z-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.