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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

CountryMakers
United States51
China9
Taiwan3
Germany3
Iceland2
Canada2
United Kingdom2
India2
New Zealand1
Switzerland1
Japan1
Malaysia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Integra LifeSciences CorporationPrinceton, NJ, United StatesComplaint file establishment, Specification developer12July 11, 2024020api.fda.gov
Acell, Inc.Columbia, MD, United StatesManufacturer6July 11, 2024000api.fda.gov
Collagen Matrix, Inc.Oakland, NJ, United StatesManufacturer, Specification developer6January 6, 2025010api.fda.gov
Reprise Biomedical, Inc.Plymouth, MN, United StatesManufacturer6April 19, 2024000api.fda.gov
Aroa Biosurgery LtdAirport Oaks Auckland, New ZealandComplaint file establishment, Manufacturer5June 24, 2026010api.fda.gov
Collagen Matrix, IncAllendale, NJ, United StatesContract manufacturer, Manufacturer5December 19, 2024000api.fda.gov
Collagen Matrix, Inc.Mahwah, NJ, United StatesContract manufacturer, Repackager or relabeler5December 19, 2024000api.fda.gov
Human Biosciences, Inc.Martinsburg, WV, United StatesManufacturer5December 15, 2021000api.fda.gov
Integra Lifesciences CorporationPlainsboro, NJ, United StatesManufacturer5February 9, 2012000api.fda.gov
Stimlabs, LLCRoswell, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler5March 19, 2026000api.fda.gov
Convatec Triad Life Sciences, LLCMemphis, TN, United StatesManufacturer4September 29, 2022000api.fda.gov
Focus Health GroupKnoxville, TN, United StatesSpecification developer4April 25, 2024000api.fda.gov
Geistlich Pharma AGWOLHUSEN Luzern, SwitzerlandComplaint file establishment, Manufacturer4March 19, 2026000api.fda.gov
Kerecis EhfIsafjordur Vestfiroir, IcelandComplaint file establishment, Manufacturer4August 21, 2024000api.fda.gov
Kerecis EhfIsafjordur Vestfiroir, IcelandComplaint file establishment, Manufacturer4August 21, 2024000api.fda.gov
Maiden BiosciencesGaithersburg, MD, United StatesComplaint file establishment, Specification developer4April 25, 2024000api.fda.gov
Cook Biotech, Inc.West Lafayette, IN, United StatesManufacturer3September 28, 2016000api.fda.gov
Maxigen Biotech, Inc.Taoyuan City, TaiwanManufacturer3October 16, 2025000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer3June 26, 2015010api.fda.gov
MedSkin Solutions Dr. Suwelack AGBILLERBECK North Rhine-Westphalia, GermanyComplaint file establishment, Contract manufacturer, Manufacturer3December 19, 2025000api.fda.gov
Rochal Technologies LLCSan Antonio, TX, United StatesSpecification developer3October 30, 2008000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer, Specification developer3June 3, 2026000api.fda.gov
Acro Biomedical Co., Ltd.Kaohsiung, TaiwanManufacturer2October 18, 2024000api.fda.gov
Bionova Medical, Inc.Germantown, TN, United StatesSpecification developer2November 13, 2023000api.fda.gov
FettechDavie, FL, United StatesManufacturer, Specification developer2April 19, 2024000api.fda.gov
FR Tech, LLCSpringboro, OH, United StatesComplaint file establishment, Specification developer2October 26, 2012000api.fda.gov
Gunze LimitedAyabe Kyoto, JapanManufacturer2July 14, 2022000api.fda.gov
Harbor Medtech, Inc.Lake Forest, CA, United StatesComplaint file establishment, Manufacturer2September 12, 2014000api.fda.gov
Huizhou Foryou Medical Devices Co.,ltd.HuiZhou Guangdong, ChinaManufacturer2April 25, 2024000api.fda.gov
Keranetics, Inc.Winston Salem, NC, United StatesSpecification developer2July 16, 2020000api.fda.gov
Nextgen Biologics, Inc.Alachua, FL, United StatesManufacturer2October 7, 2021000api.fda.gov
Novabone Products, LLCAlachua, FL, United StatesManufacturer2June 9, 2023000api.fda.gov
Organogenesis Inc.Canton, MA, United StatesManufacturer2July 1, 2022000api.fda.gov
Roosin Medical Co., Ltd.Taizhou Jiangsu, ChinaManufacturer2June 3, 2026000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyComplaint file establishment, Exporter to the US, Specification developer2February 14, 2002000api.fda.gov
Winner Medical Co., Ltd.SHENZHEN Guangdong, ChinaExporter to the US, Specification developer2October 10, 2025000api.fda.gov
Advamedica Inc.Cambridge, MA, United StatesComplaint file establishment, Manufacturer1August 24, 2023000api.fda.gov
Advanced Medical Solutions Saal GmbHSaal/Donau Bavaria, GermanyManufacturer1May 1, 2014000api.fda.gov
Berkeley Advanced BiomaterialsBerkeley, CA, United StatesManufacturer1August 27, 2026000api.fda.gov
Coreleader Biotech Co., LtdNew Taipei City, TaiwanManufacturer1May 20, 2011000api.fda.gov
Covalon Technologies Inc.MISSISSAUGA Ontario, CanadaComplaint file establishment, Manufacturer1September 9, 2026000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesManufacturer1February 10, 2012000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer1October 10, 2025000api.fda.gov
Ecm Therapeutics, Inc.Warrendale, PA, United StatesManufacturer1June 18, 2026000api.fda.gov
Encoll Corp.Fremont, CA, United StatesManufacturer1August 12, 2004000api.fda.gov
Fesarius TherapeuticsNew York, NY, United StatesComplaint file establishment, Specification developer1January 6, 2025000api.fda.gov
Foshan United Medical Technologies Ltd.Foshan Guangdong, ChinaManufacturer1January 26, 2015000api.fda.gov
HongYu BioTech (ShenZhen) Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer1June 3, 2026000api.fda.gov
HuiZhou Foryou Medical Devices Co., LTD.Huizhou Guangdong, ChinaManufacturer1September 20, 2022000api.fda.gov
Integra LifeSciences Braintree Inc.Braintree, MA, United StatesManufacturer1February 22, 2016020api.fda.gov
LMC Opco, LLCWoodstock, GA, United StatesComplaint file establishment, Specification developer1December 22, 2025000api.fda.gov
MLM BiologicsAlachua, FL, United StatesManufacturer1July 22, 2014000api.fda.gov
MPM MedicalMesquite, TX, United StatesSpecification developer1July 25, 2017000api.fda.gov
Novex Innovations, LLCWinston Salem, NC, United StatesManufacturer1April 19, 2024000api.fda.gov
Ovigenex LLCRancho Dominguez, CA, United StatesManufacturer, Specification developer1October 26, 2012000api.fda.gov
Secada Medical, LLC D.B.A Ventris MedicalNewport Beach, CA, United StatesComplaint file establishment, Specification developer1July 2, 2026000api.fda.gov
Southwest Technologies, Inc.North Kansas City, MO, United StatesManufacturer1August 9, 2004010api.fda.gov
Smith & Nephew Medical LtdHULL East Riding of Yorkshire, United KingdomSpecification developer1December 17, 2024000api.fda.gov
Strukmyer MedicalMesquite, TX, United StatesContract manufacturer, Manufacturer1July 25, 2017000api.fda.gov
Viscus Biologics, LLC.Cleveland, OH, United StatesContract manufacturer, Manufacturer1June 26, 2015000api.fda.gov
Advanced Biotech Products (P), Ltd.CHENNAI Tamil Nadu, IndiaContract manufacturer0000api.fda.gov
Axio Biosolutions Pvt LtdAhmedabad Gujarat, IndiaContract manufacturer0000api.fda.gov
Attwill Medical SolutionsLodi, WI, United StatesContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Derma Sciences Canada, IncTORONTO Ontario, CanadaContract manufacturer0000api.fda.gov
Derma Sciences Nantong IncorporationDEVELOPMENT Jiangsu, ChinaContract manufacturer0000api.fda.gov
Dexios Services, LLC.Cornelius, NC, United StatesContract manufacturer0000api.fda.gov
FabriteqKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
Jiangsu Newvalue Medical Products Co., Ltd.Taizhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Lyophilization Services Of New England, Inc.Manchester, NH, United StatesContract manufacturer0000api.fda.gov
Quality Bioresources, IncSeguin, TX, United StatesContract manufacturer0000api.fda.gov
Speciality Pharma MFGCarlstadt, NJ, United StatesContract manufacturer0000api.fda.gov
Steripack Asia Sdn BhdKlang Selangor, MalaysiaContract manufacturer, Contract sterilizer0000api.fda.gov
Stymco Medical LLCTampa, FL, United StatesContract manufacturer0000api.fda.gov
Systagenix Wound Management Manufacturing LimitedNorth Yorkshire, United KingdomContract manufacturer, Contract sterilizer0000api.fda.gov
VLV Associates, Inc.Whippany, NJ, United StatesContract manufacturer0000api.fda.gov
Winner Medical Co., Ltd., Shenzhen BranchShenzhen Guangdong, ChinaContract manufacturer0000api.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.