Organogenesis, Inc.
Medical device manufacturer in Canton, MA.
12510(k) clearances
1PMA approvals
6recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix)KGN · Traditional | 05/02/2023SE |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ)KGN · Traditional | 07/01/2022SE |
| K071555 | Fortagen Oral MembraneNPL · Traditional | 08/30/2007SE |
| K051647 | Fortaderm Antimicrobial Wound DressingFRO · Traditional | 11/08/2005SE |
| K042809 | CuffpatchFTM · Traditional | 11/02/2004SE |
| K021107 | Fortaflex Surgical SlingFTM · Traditional | 05/15/2002SE |
| K021105 | Fortaflex Surgical MeshFTM · Traditional | 05/10/2002SE |
| K020049 | Fortaflex Surgical MeshFTM · Traditional | 03/18/2002SE |
| K011025 | Fortaflex Surgical MeshFTM · Traditional | 08/24/2001SE |
| K011026 | Fortaderm Wound DressingKGN · Traditional | 06/13/2001SE |
| K011027 | Fortaflex Surgical SlingFTM · Traditional | 05/30/2001SE |
| K970561 | Graft PatchFTL · Traditional | 08/01/1997SE |
PMA approvals
- P950032 Apligraf (Graftskin) · 05/22/1998 · 66 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1747-2011 | Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living…Product sterility may be compromised | 02/21/2011Terminated |
| Z-1746-2011 | Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living…Product sterility compromised | 01/30/2011Terminated |
| Z-2589-2010 | Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100…Product is contaminated with a yeast identified as Pseudozyma antarctica. | 08/02/2010Terminated |
| Z-0181-2010 | Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use…Unit contaminated with Staphylococcus epidermidis | 09/27/2009Terminated |
| Z-0675-2008 | Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc.…Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some… | 12/26/2007Terminated |
| Z-0068-2007 | Apligraf (Graftskin)Product pH out of specification | 09/29/2006Terminated |