Cadwell Industries Inc
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 12
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2349-2024 | Class II | Cascade IOMAX Cortical Module, REF: 190296-200 | May 17, 2024 |
| Z-1882-2024 | Class II | Cascade IOMAX Cortical Module, REF: 190296-200 | April 23, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250851 | Hypnos (369054-200) | December 14, 2025 |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | December 18, 2024 |
| K230415 | Cadwell Guardian | August 17, 2023 |
| K201819 | Cadwell Apollo System | September 29, 2020 |
| K192624 | ApneaTrak | February 20, 2020 |
| K190760 | Cadwell Bolt Software | November 23, 2019 |
| K181466 | Cadwell Zenith System | September 1, 2018 |
| K180269 | Cadwell Apollo System | July 17, 2018 |
| K162199 | Cascade IOMAX Intraoperative Monitor | March 2, 2017 |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | March 1, 2017 |
| K161027 | Cadwell AmpliScan | November 8, 2016 |
| K133355 | CADWELL FLEX EEG/PSG | January 29, 2014 |