510(k) K162199 ยท GWF Stimulator, Electrical, Evoked Response
Cascade IOMAX Intraoperative Monitor
| Applicant | Cadwell Industries, Inc., Kennewick WA, US |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Aug 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Cadwell Industries Inc Brand Name: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low Open, Classified |
GWF | None listed |
| Jul 12, 2024 | Cadwell Industries Inc Cascade IOMAX Cortical Module, REF: 190296-200 Open, Classified |
GWF | None listed |
| May 22, 2024 | Cadwell Industries Inc Cascade IOMAX Cortical Module, REF: 190296-200 Open, Classified |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.