Home › Device types › GWF
Stimulator, Electrical, Evoked Response
FDA product code GWF · Class 2 · Neurology
1,703
Registered devices
3,348
Adverse events
17
Recalls
141
510(k) clearances
Devices with this code
MagPro — Tonica Elektronik A/SPOWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.NVM5 — Nuvasive, Inc.PULSE — Nuvasive, Inc.NA — NIHON KOHDEN AMERICA, INC.NVM5 — Nuvasive, Inc.NA — NIHON KOHDEN CORPORATIONN/A — inomed Medizintechnik GmbHNA — Nuvasive, Inc.N/A — inomed Medizintechnik GmbHEPAD — SAFEOP SURGICAL, INC.N/A — inomed Medizintechnik GmbHPULSE — Nuvasive, Inc.Natus — NATUS NEUROLOGY INCORPORATEDKeypoint — NATUS MANUFACTURING LIMITEDN/A — MEDTRONIC SOFAMOR DANEK, INC.NA — NIHON KOHDEN AMERICA, INC.POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.PULSE — Nuvasive, Inc.Butterfly Coil 70 mm air cooled — EB NEURO SPANatus — NATUS NEUROLOGY INCORPORATEDEPAD — SAFEOP SURGICAL, INC.Alpine Biomed — Alpine Biomed ApSXltek — XLTEK
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Cadwell Industries Inc | Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.