Kennewick, WA, US · 6 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Class II | Neurology | 1 | 2026-06-26 |
| OLZ | — | — | — | 1 | 2025-12-14 |
| MNR | — | — | — | 1 | 2024-12-18 |
| GWF | Stimulator, Electrical, Evoked Response | Class II | Neurology | 1 | 2023-08-17 |
| GWQ | Full-Montage Standard Electroencephalograph | Class II | Neurology | 1 | 2020-09-29 |
| OLV | Standard Polysomnograph With Electroencephalograph | Class II | Neurology | 1 | 2020-02-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-05-17 | Class II | Ongoing | Z-2349-2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | — | 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 | Class II | Ongoing | Z-1882-2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | — | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-26 | K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | GXY | Class II | Neurology |
| 2025-12-14 | K250851 | Hypnos (369054-200) | OLZ | — | — |
| 2024-12-18 | K242424 | Bluebird Single-Use Respiratory Effort Belt | MNR | — | — |
| 2023-08-17 | K230415 | Cadwell Guardian | GWF | Class II | Neurology |
| 2020-09-29 | K201819 | Cadwell Apollo System | GWQ | Class II | Neurology |
| 2020-02-20 | K192624 | ApneaTrak | OLV | Class II | Neurology |