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Data / Medical devices / Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Hemostatic Wound Dressing Without Thrombin Or Other Biologics (QSY): 64 FDA-registered makers in 16 countries

64 establishments in 16 countries are registered with the FDA to make Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY, Class U). 42 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 127 510(k) clearances under this code, the latest on April 30, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QSY
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
United States35
China7
United Kingdom4
Taiwan3
Dominican Republic3
Mexico2
Israel1
Italy1
France1
South Korea1
India1
Canada1
Netherlands1
Germany1
Poland1
Egypt1

Makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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
Medtrade Products Ltd.CHESHIRE Cheshire East, United KingdomManufacturer, Specification developer11November 17, 2023000api.fda.gov
Tricol Biomedical, INC.Portland, OR, United StatesSpecification developer6November 10, 2015000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer5December 24, 2018000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer5December 24, 2018000api.fda.gov
Z-Medica, LLCNorth Haven, CT, United StatesManufacturer, Repackager or relabeler5December 24, 2018000api.fda.gov
Z-Medica, LLCWallingford, CT, United StatesManufacturer, Repackager or relabeler5December 24, 2018000api.fda.gov
Lifescience Plus, Inc.Mountain View, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4April 30, 2026000api.fda.gov
Biolife, LLCSarasota, FL, United StatesManufacturer3July 9, 2013000api.fda.gov
Hemostasis, LLCSaint Paul, MN, United StatesManufacturer3November 15, 2012000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer3July 9, 2013000api.fda.gov
Advamedica Inc.Cambridge, MA, United StatesComplaint file establishment, Manufacturer, Specification developer2April 7, 2023000api.fda.gov
Chitogen IncMaple Grove, MN, United StatesManufacturer, Specification developer2August 2, 2012000api.fda.gov
Core Scientific Creations LtdPetach Tikva Central, IsraelManufacturer2August 8, 2016000api.fda.gov
Coreleader Biotech Co., LtdNew Taipei City, TaiwanManufacturer2July 31, 2015000api.fda.gov
Cresilon IncBrooklyn, NY, United StatesManufacturer2December 12, 2025000api.fda.gov
Hangzhou Zeo-Innov Life Technology Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer2May 2, 2023000api.fda.gov
Starch Medical Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer2March 15, 2024000api.fda.gov
Advanced Vascular DynamicsTigard, OR, United StatesManufacturer1April 12, 2018000api.fda.gov
BC3 TechnologiesBaltimore, MD, United StatesComplaint file establishment, Specification developer1February 2, 2023000api.fda.gov
Bestreat Safety & First Aid Solution Co., LtdWuhan Hubei, ChinaManufacturer1September 1, 2023000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer1August 21, 2012000api.fda.gov
Beeken Biomedical LLCNewton, MA, United StatesComplaint file establishment, Specification developer1June 29, 2016000api.fda.gov
CoagSaint Paul, MN, United StatesManufacturer1July 28, 2014000api.fda.gov
Davol Inc.Woburn, MA, United StatesManufacturer1December 17, 2003000api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI, United StatesComplaint file establishment, Specification developer1December 17, 2003000api.fda.gov
Euroresearch S.R.L.MILANO Lombardy, ItalyManufacturer1July 22, 2005000api.fda.gov
Huizhou Foryou Medical Devices Co.,ltd.HuiZhou Guangdong, ChinaManufacturer1May 23, 2012000api.fda.gov
Identipak Inc.McAllen, TX, United StatesManufacturer, Repackager or relabeler1October 25, 2019000api.fda.gov
Jiangsu Newvalue Medical Products Co., Ltd.Taizhou Jiangsu, ChinaExporter to the US, Manufacturer1September 1, 2023000api.fda.gov
Koag International LLCVonore, TN, United StatesSpecification developer1July 29, 2022000api.fda.gov
Laboratoires Brothier, S.A.FONTEVRAUD L ABBAYE Maine-et-Loire, FranceManufacturer1February 2, 2011000api.fda.gov
Machina Medical CorporationRoswell, GA, United StatesComplaint file establishment, Specification developer1December 15, 2025000api.fda.gov
Medcura, Inc. (fka Gel-E, Inc.)Riverdale, MD, United StatesComplaint file establishment, Manufacturer1October 25, 2019000api.fda.gov
Safeguard Medical Technologies LtdHereford Herefordshire, United KingdomSpecification developer1May 25, 2016000api.fda.gov
Sam Medical ProductsTualatin, OR, United StatesSpecification developer1May 22, 2014000api.fda.gov
SCL Science Inc.Seoul, South KoreaManufacturer1November 29, 2016000api.fda.gov
Speciality Fibres and Materials LimitedCoventry, United KingdomManufacturer1February 26, 2026000api.fda.gov
T-Scientific International, Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicSpecification developer1April 21, 2003000api.fda.gov
Tacmed Solutions, LLCAnderson, SC, United StatesSpecification developer1August 25, 2009000api.fda.gov
Taizhou Xinkang Medical Materials Co., LtdTaizhou Jiangsu, ChinaExporter to the US, Manufacturer, Repackager or relabeler1May 2, 2023000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer, Specification developer1May 11, 2004000api.fda.gov
Unicare Biomedical, Inc.Laguna Hills, CA, United StatesRepackager or relabeler, Specification developer1November 12, 2008000api.fda.gov
Acupac Packaging, Inc.Mahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Aerosol And Liquid PackagingBaltimore, MD, United StatesContract manufacturer0000api.fda.gov
Axio Biosolutions Pvt LtdAhmedabad Gujarat, IndiaContract manufacturer0000api.fda.gov
Beijing Huan Qiu Li Kang Biotech Co., Ltd.Beijing, ChinaContract manufacturer0000api.fda.gov
Benefit Coatings, Inc.Stratford, CT, United StatesContract manufacturer0000api.fda.gov
Benq Materials CorporationGueishan Taoyuan, TaiwanContract manufacturer0000api.fda.gov
Beijing Taikesiman Technology Development Co., LTDLi Qiao Beijing, ChinaContract manufacturer0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Derma Sciences Canada, IncTORONTO Ontario, CanadaContract manufacturer0000api.fda.gov
HCM MedicalNijmegen Gelderland, NetherlandsContract manufacturer0000api.fda.gov
Horng Tzer Medical Instruments, Ltd.Kaohsiung, TaiwanContract manufacturer0000api.fda.gov
Ipc Process-Center GMBH & Co. KGDresden Saxony, GermanyContract manufacturer0000api.fda.gov
Ivor Shaw, Ltd.Derby, United KingdomContract manufacturer0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
Jago-Pro SP. Z O.O.JAWORZNO Slaskie, PolandContract manufacturer0000api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
OVIK HealthColumbus, NC, United StatesContract manufacturer0000api.fda.gov
Pharmaplast S.A.E.ALEXANDRIA Al Iskandariyah, EgyptContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Vexxus Medical Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer0000api.fda.gov

Updated April 30, 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.