Foster City, CA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CCJ | — | — | — | 1 | 2026-05-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-04-21 | Class II | Ongoing | Z-2198-2025 | Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor | — | Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to in… |