Organogenesis, Inc.
Organogenesis, Inc. has 0 FDA recalls, 15 inspections, 12 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Dec 1, 2021 · NAI
- Latest 510(k)
- May 2, 2023
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 12 | Oct 4, 2026 | Not stated | Current |
| Inspections | 15 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 1, 2021 | Canton, MA | Biologics | No Action Indicated (NAI) | 1000148471 |
| Jun 8, 2018 | Canton, MA | Biologics | Voluntary Action Indicated (VAI) | 1000148471 |
| Apr 26, 2018 | Canton, MA | Biologics | Voluntary Action Indicated (VAI) | 1000148471 |
| May 26, 2017 | Canton, MA | Devices | No Action Indicated (NAI) | 1000148471 |
| Sep 9, 2015 | Canton, MA | Biologics | No Action Indicated (NAI) | 1000148471 |
| Jun 13, 2014 | Canton, MA | Devices | Voluntary Action Indicated (VAI) | 1000148471 |
| Oct 29, 2013 | Canton, MA | Biologics | Voluntary Action Indicated (VAI) | 1000148471 |
| Jun 3, 2013 | Canton, MA | Devices | Voluntary Action Indicated (VAI) | 1000148471 |
| May 1, 2013 | Canton, MA | Biologics | No Action Indicated (NAI) | 1000148471 |
| May 7, 2012 | Canton, MA | Devices | No Action Indicated (NAI) | 1000148471 |
| Apr 12, 2012 | Canton, MA | Devices | No Action Indicated (NAI) | 1000148471 |
| Jul 29, 2011 | Canton, MA | Devices | No Action Indicated (NAI) | 1000148471 |
| Apr 7, 2011 | Canton, MA | Biologics | No Action Indicated (NAI) | 1000148471 |
| Jul 27, 2010 | Canton, MA | Devices | No Action Indicated (NAI) | 1000148471 |
| Oct 29, 2008 | Canton, MA | Devices | No Action Indicated (NAI) | 1000148471 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | May 2, 2023 |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Jul 1, 2022 |
| K071555 | FORTAGEN ORAL MEMBRANE | Aug 30, 2007 |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | Nov 8, 2005 |
| K042809 | CUFFPATCH | Nov 2, 2004 |
| K021107 | FORTAFLEX SURGICAL SLING | May 15, 2002 |
| K021105 | FORTAFLEX SURGICAL MESH | May 10, 2002 |
| K020049 | FORTAFLEX SURGICAL MESH | Mar 18, 2002 |
| K011025 | FORTAFLEX SURGICAL MESH | Aug 24, 2001 |
| K011026 | FORTADERM WOUND DRESSING | Jun 13, 2001 |
| K011027 | FORTAFLEX SURGICAL SLING | May 30, 2001 |
| K970561 | GRAFT PATCH | Aug 1, 1997 |