Home › Device types › ETN
Stimulator, Nerve
FDA product code ETN · Class 2 · Ear, Nose, Throat
1,819
Registered devices
5,083
Adverse events
31
Recalls
97
510(k) clearances
Devices with this code
Zenith — CADWELL INDUSTRIES, INC.Neurosign Stimulator Probe Pod — THE MAGSTIM COMPANY LIMITEDGuidance — Nuvasive, Inc.NA — MEDTRONIC XOMED, INC.ReLine — Nuvasive, Inc.NVJJB — Nuvasive, Inc.N/A — MEDTRONIC SOFAMOR DANEK, INC.N/A — inomed Medizintechnik GmbHIOMAX Extender Pod — CADWELL INDUSTRIES, INC.Cobra — Neurovision Medical Products, Inc.Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC.PULSE — Nuvasive, Inc.IOM Stimulator Probes — SPES MEDICA SPANIM-Response® — MEDTRONIC XOMED, INC.Checkpoint Gemini — Checkpoint Surgical, Inc.MaXcess — Nuvasive, Inc.NVM5 — Nuvasive, Inc.NVM5 — Nuvasive, Inc.SafeOp — ALPHATEC SPINE, INC.N/A — inomed Medizintechnik GmbHMaXcess — Nuvasive, Inc.Cadwell — Xi'an Friendship Medical Electronics Co.,Ltd.NIM TriVantage™ — MEDTRONIC XOMED, INC.N/A — inomed Medizintechnik GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-19 | Neurovision Medical Products Inc | Product packaging contains the wrong part number and kit contents. |
| 2025-02-24 | Checkpoint Surgical Inc | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There |
| 2025-02-24 | Checkpoint Surgical Inc | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There |
| 2024-07-25 | Technomed Europe | Product has have presence of brown discoloration or substance on the hinge area of the device |
| 2024-07-01 | Neurovision Medical Products Inc | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. |
| 2023-11-07 | Medtronic Xomed, Inc. | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, |
| 2022-04-29 | Medtronic Xomed, Inc. | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotr |
| 2022-04-29 | Medtronic Xomed, Inc. | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotr |
| 2022-04-29 | Medtronic Xomed, Inc. | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotr |
| 2021-12-22 | Medtronic Xomed, Inc. | There is potential for multiple issues due to a manufacturing nonconformity. |
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