Data / Medical devices / Wound Dressing With Animal-Derived Material(S)
Wound Dressing With Animal-Derived Material(S) (KGN): 78 FDA-registered makers in 12 countries
78 establishments in 12 countries are registered with the FDA to make Wound Dressing With Animal-Derived Material(S) (product code KGN, Class U). 60 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 194 510(k) clearances under this code, the latest on October 22, 2026, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 51 |
| China | 9 |
| Taiwan | 3 |
| Germany | 3 |
| Iceland | 2 |
| Canada | 2 |
| United Kingdom | 2 |
| India | 2 |
| New Zealand | 1 |
| Switzerland | 1 |
| Japan | 1 |
| Malaysia | 1 |
Makers of Wound Dressing With Animal-Derived Material(S)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Aroa Biosurgery Ltd | Airport Oaks Auckland, New Zealand | Complaint file establishment, Manufacturer | 5 | June 24, 2026 | 0 | 1 | 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 |
| Geistlich Pharma AG | WOLHUSEN Luzern, Switzerland | Complaint file establishment, Manufacturer | 4 | March 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Kerecis Ehf | Isafjordur Vestfiroir, Iceland | Complaint file establishment, Manufacturer | 4 | August 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Kerecis Ehf | Isafjordur Vestfiroir, Iceland | Complaint file establishment, Manufacturer | 4 | August 21, 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 |
| Maxigen Biotech, Inc. | Taoyuan City, Taiwan | Manufacturer | 3 | October 16, 2025 | 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 |
| MedSkin Solutions Dr. Suwelack AG | BILLERBECK North Rhine-Westphalia, Germany | Complaint file establishment, Contract manufacturer, Manufacturer | 3 | December 19, 2025 | 0 | 0 | 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 |
| Acro Biomedical Co., Ltd. | Kaohsiung, Taiwan | Manufacturer | 2 | October 18, 2024 | 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 |
| Gunze Limited | Ayabe Kyoto, Japan | Manufacturer | 2 | July 14, 2022 | 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 |
| Huizhou Foryou Medical Devices Co.,ltd. | HuiZhou Guangdong, China | Manufacturer | 2 | April 25, 2024 | 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 |
| Roosin Medical Co., Ltd. | Taizhou Jiangsu, China | Manufacturer | 2 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Complaint file establishment, Exporter to the US, Specification developer | 2 | February 14, 2002 | 0 | 0 | 0 | api.fda.gov |
| Winner Medical Co., Ltd. | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 2 | October 10, 2025 | 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 |
| Advanced Medical Solutions Saal GmbH | Saal/Donau Bavaria, Germany | Manufacturer | 1 | May 1, 2014 | 0 | 0 | 0 | api.fda.gov |
| Berkeley Advanced Biomaterials | Berkeley, CA, United States | Manufacturer | 1 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Coreleader Biotech Co., Ltd | New Taipei City, Taiwan | Manufacturer | 1 | May 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| Covalon Technologies Inc. | MISSISSAUGA Ontario, Canada | Complaint file establishment, Manufacturer | 1 | September 9, 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 |
| Foshan United Medical Technologies Ltd. | Foshan Guangdong, China | Manufacturer | 1 | January 26, 2015 | 0 | 0 | 0 | api.fda.gov |
| HongYu BioTech (ShenZhen) Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| HuiZhou Foryou Medical Devices Co., LTD. | Huizhou Guangdong, China | Manufacturer | 1 | September 20, 2022 | 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 |
| Smith & Nephew Medical Ltd | HULL East Riding of Yorkshire, United Kingdom | Specification developer | 1 | December 17, 2024 | 0 | 0 | 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 |
| Advanced Biotech Products (P), Ltd. | CHENNAI Tamil Nadu, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axio Biosolutions Pvt Ltd | Ahmedabad Gujarat, India | Contract manufacturer | 0 | 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 | |
| Derma Sciences Canada, Inc | TORONTO Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derma Sciences Nantong Incorporation | DEVELOPMENT Jiangsu, China | 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 | |
| Jiangsu Newvalue Medical Products Co., Ltd. | Taizhou Jiangsu, China | 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 | |
| Steripack Asia Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stymco Medical LLC | Tampa, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Systagenix Wound Management Manufacturing Limited | North Yorkshire, United Kingdom | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VLV Associates, Inc. | Whippany, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Winner Medical Co., Ltd., Shenzhen Branch | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 22, 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.