Home › Device types › GWF
Stimulator, Electrical, Evoked Response
FDA product code GWF · Class 2 · Neurology
1,700
Registered devices
3,228
Adverse events
16
Recalls
140
510(k) clearances
Devices with this code
NA — MEDTRONIC XOMED, INC.Zenith — CADWELL INDUSTRIES, INC.Sierra Summit — CADWELL INDUSTRIES, INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.Natus — XLTEKNA — NIHON KOHDEN CORPORATIONMicromed — MICROMED SPAGuidance — Nuvasive, Inc.Alpine BioMed — Alpine Biomed ApSNA — MEDTRONIC XOMED, INC.POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.NA — MEDTRONIC XOMED, INC.NVJJB — Nuvasive, Inc.NA — NIHON KOHDEN AMERICA, INC.Natus — NATUS MANUFACTURING LIMITEDNatus — NATUS NEUROLOGY INCORPORATEDCascade Elite — CADWELL INDUSTRIES, INC.N/A — inomed Medizintechnik GmbHIOMAX Extender Pod — CADWELL INDUSTRIES, INC.Nihon Kohden, EEG-1200A Series Neurofax — NIHON KOHDEN CORPORATIONCobra — Neurovision Medical Products, Inc.PULSE — Nuvasive, Inc.NIM-Response® — MEDTRONIC XOMED, INC.EPAD — SAFEOP SURGICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-13 | Alphatec Spine, Inc. | Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during us |
| 2025-03-10 | Medtronic Xomed, Inc. | Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedu |
| 2024-06-24 | Medtronic Xomed, Inc. | Potential for false negative response on the NIM Vital Nerve Monitoring System |
| 2024-05-17 | Cadwell Industries Inc | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unint |
| 2024-04-23 | Cadwell Industries Inc | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections |
| 2022-05-03 | Medtronic Xomed, Inc. | Software anomaly was identified. |
| 2022-05-03 | Medtronic Xomed, Inc. | Software anomaly was identified. |
| 2017-03-14 | Nexstim PLC | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
| 2017-03-14 | Nexstim PLC | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
| 2015-01-02 | Natus Medical Incorporated | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing th |
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