Corneagen, Inc.
Corneagen, Inc. has 0 FDA recalls, 27 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Sep 22, 2026 · NAI
- Latest 510(k)
- Feb 2, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
| Inspections | 27 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 22, 2026 | Baltimore, MD | Biologics | No Action Indicated (NAI) | 3001236461 |
| Sep 16, 2026 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3005357288 |
| Apr 30, 2026 | Seattle, WA | Biologics | No Action Indicated (NAI) | 3015927085 |
| Sep 10, 2025 | South San Francisco, CA | Biologics | No Action Indicated (NAI) | 3009122697 |
| Mar 25, 2024 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3010664398 |
| May 31, 2023 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3005357288 |
| Jan 13, 2023 | Seattle, WA | Biologics | No Action Indicated (NAI) | 3015927085 |
| Jul 29, 2022 | South San Francisco, CA | Biologics | Voluntary Action Indicated (VAI) | 3009122697 |
| Sep 24, 2021 | Seattle, WA | Biologics | No Action Indicated (NAI) | 3015927085 |
| Sep 15, 2021 | Baltimore, MD | Biologics | No Action Indicated (NAI) | 3001236461 |
| Jul 14, 2021 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3005357288 |
| Sep 14, 2018 | Baltimore, MD | Biologics | No Action Indicated (NAI) | 3001236461 |
| Jul 20, 2018 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3005357288 |
| Feb 27, 2018 | South San Francisco, CA | Biologics | No Action Indicated (NAI) | 3009122697 |
| Oct 20, 2017 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3010664398 |
| Aug 22, 2016 | Baltimore, MD | Biologics | No Action Indicated (NAI) | 3001236461 |
| Jun 15, 2016 | South San Francisco, CA | Biologics | Voluntary Action Indicated (VAI) | 3009122697 |
| Oct 22, 2015 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3005357288 |
| Sep 11, 2015 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3010664398 |
| Mar 25, 2014 | Baltimore, MD | Biologics | No Action Indicated (NAI) | 3001236461 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K203586 | EndoSerter-PL | Feb 2, 2022 |