Data / Medical devices / Wound Dressing With Animal-Derived Material(S) / United States
FDA-registered makers of Wound Dressing With Animal-Derived Material(S) in the United States: 51 establishments
51 establishments in the United States are registered with the FDA to make Wound Dressing With Animal-Derived Material(S) (product code KGN). 41 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Wound Dressing With Animal-Derived Material(S)
- Product code
- KGN
- Country
- United States
Makers of Wound Dressing With Animal-Derived Material(S) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Integra LifeSciences Corporation | Princeton, NJ, United States | Complaint file establishment, Specification developer | 12 | July 11, 2024 | 0 | 2 | 0 | api.fda.gov |
| Acell, Inc. | Columbia, MD, United States | Manufacturer | 6 | July 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Oakland, NJ, United States | Manufacturer, Specification developer | 6 | January 6, 2025 | 0 | 1 | 0 | api.fda.gov |
| Reprise Biomedical, Inc. | Plymouth, MN, United States | Manufacturer | 6 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Contract manufacturer, Manufacturer | 5 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Mahwah, NJ, United States | Contract manufacturer, Repackager or relabeler | 5 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Human Biosciences, Inc. | Martinsburg, WV, United States | Manufacturer | 5 | December 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Plainsboro, NJ, United States | Manufacturer | 5 | February 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| Stimlabs, LLC | Roswell, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | March 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Convatec Triad Life Sciences, LLC | Memphis, TN, United States | Manufacturer | 4 | September 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Focus Health Group | Knoxville, TN, United States | Specification developer | 4 | April 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Maiden Biosciences | Gaithersburg, MD, United States | Complaint file establishment, Specification developer | 4 | April 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 3 | September 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 3 | June 26, 2015 | 0 | 1 | 0 | api.fda.gov |
| Rochal Technologies LLC | San Antonio, TX, United States | Specification developer | 3 | October 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Safe N Simple LLC | Clarkston, MI, United States | Manufacturer, Specification developer | 3 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bionova Medical, Inc. | Germantown, TN, United States | Specification developer | 2 | November 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Fettech | Davie, FL, United States | Manufacturer, Specification developer | 2 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| FR Tech, LLC | Springboro, OH, United States | Complaint file establishment, Specification developer | 2 | October 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Harbor Medtech, Inc. | Lake Forest, CA, United States | Complaint file establishment, Manufacturer | 2 | September 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| Keranetics, Inc. | Winston Salem, NC, United States | Specification developer | 2 | July 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nextgen Biologics, Inc. | Alachua, FL, United States | Manufacturer | 2 | October 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| Novabone Products, LLC | Alachua, FL, United States | Manufacturer | 2 | June 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Organogenesis Inc. | Canton, MA, United States | Manufacturer | 2 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Advamedica Inc. | Cambridge, MA, United States | Complaint file establishment, Manufacturer | 1 | August 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Berkeley Advanced Biomaterials | Berkeley, CA, United States | Manufacturer | 1 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| DSM Biomedical, Inc. | Exton, PA, United States | Manufacturer | 1 | February 10, 2012 | 0 | 0 | 0 | api.fda.gov |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 1 | October 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ecm Therapeutics, Inc. | Warrendale, PA, United States | Manufacturer | 1 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Encoll Corp. | Fremont, CA, United States | Manufacturer | 1 | August 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fesarius Therapeutics | New York, NY, United States | Complaint file establishment, Specification developer | 1 | January 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Braintree Inc. | Braintree, MA, United States | Manufacturer | 1 | February 22, 2016 | 0 | 2 | 0 | api.fda.gov |
| LMC Opco, LLC | Woodstock, GA, United States | Complaint file establishment, Specification developer | 1 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| MLM Biologics | Alachua, FL, United States | Manufacturer | 1 | July 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| MPM Medical | Mesquite, TX, United States | Specification developer | 1 | July 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Novex Innovations, LLC | Winston Salem, NC, United States | Manufacturer | 1 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ovigenex LLC | Rancho Dominguez, CA, United States | Manufacturer, Specification developer | 1 | October 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Secada Medical, LLC D.B.A Ventris Medical | Newport Beach, CA, United States | Complaint file establishment, Specification developer | 1 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Southwest Technologies, Inc. | North Kansas City, MO, United States | Manufacturer | 1 | August 9, 2004 | 0 | 1 | 0 | api.fda.gov |
| Strukmyer Medical | Mesquite, TX, United States | Contract manufacturer, Manufacturer | 1 | July 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Viscus Biologics, LLC. | Cleveland, OH, United States | Contract manufacturer, Manufacturer | 1 | June 26, 2015 | 0 | 0 | 0 | api.fda.gov |
| Attwill Medical Solutions | Lodi, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Haverhill, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dexios Services, LLC. | Cornelius, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabriteq | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lyophilization Services Of New England, Inc. | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Bioresources, Inc | Seguin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speciality Pharma MFG | Carlstadt, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stymco Medical LLC | Tampa, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VLV Associates, Inc. | Whippany, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.