Data / Medical devices / United States / Organogenesis Inc.
Organogenesis Inc.: FDA-registered device maker in Canton, MA, United States, 4 510(k) clearances
Organogenesis Inc. is registered with the FDA (registration 1221816) in Canton, MA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 1, 2022. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1221816
- FEI number
- 1000148471
- Address
- 150 Dan RD., Canton, MA, United States, 02021
- Owner or operator
- Organogenesis Inc. (9008375)
- Roles
- Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2027
- Brand names listed
- Apligraf, Dermagraft, FortaDerm Antimicrobial Wound Dressing, FortaDerm Wound Dressing, PuraForce 6.5cm x 9cm (Previously known as CuffPatch and Inforce), PuraForce 6cm x 2cm (Previously known as CuffPatch and Inforce), PuraForce 6cm x 3cm (Previously known as CuffPatch and Inforce), PuraForce 8cm x 4cm (Previously known as CuffPatch and Inforce) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cultured Human Cell Skin Dressing | PFC | 3 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound And Burn, Interactive | MGR | 3 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2022 | K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | KGN | Substantially Equivalent | Organogenesis, Inc. | accessdata.fda.gov |
| November 8, 2005 | K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | FRO | Substantially Equivalent | Organogenesis, Inc. | accessdata.fda.gov |
| November 2, 2004 | K042809 | CUFFPATCH | FTM | Substantially Equivalent | Organogenesis, Inc. | accessdata.fda.gov |
| June 13, 2001 | K011026 | FORTADERM WOUND DRESSING | KGN | Substantially Equivalent | Organogenesis, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 21, 2011 | 58138 | Not yet classified | Terminated | Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute | Product sterility may be compromised | accessdata.fda.gov |
| January 30, 2011 | 57824 | Not yet classified | Terminated | Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute | Product sterility compromised | accessdata.fda.gov |
| August 2, 2010 | 56543 | Not yet classified | Terminated | Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to | Product is contaminated with a yeast identified as Pseudozyma antarctica. | accessdata.fda.gov |
| September 27, 2009 | 53458 | Not yet classified | Terminated | Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatmen | Unit contaminated with Staphylococcus epidermidis | accessdata.fda.gov |
| December 26, 2007 | 46250 | Not yet classified | Terminated | Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021 | Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism. | accessdata.fda.gov |
| September 29, 2006 | 36468 | Not yet classified | Terminated | Apligraf (Graftskin) | Product pH out of specification | accessdata.fda.gov |
| May 2, 2003 | 26327 | Not yet classified | Terminated | Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in.. | Did not meet finished device specifications for the DNA criteria. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound And Burn, Interactive
- All makers of Mesh, Surgical
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated July 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.