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
| Country | Makers |
|---|---|
| United States | 35 |
| China | 7 |
| United Kingdom | 4 |
| Taiwan | 3 |
| Dominican Republic | 3 |
| Mexico | 2 |
| Israel | 1 |
| Italy | 1 |
| France | 1 |
| South Korea | 1 |
| India | 1 |
| Canada | 1 |
| Netherlands | 1 |
| Germany | 1 |
| Poland | 1 |
| Egypt | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtrade Products Ltd. | CHESHIRE Cheshire East, United Kingdom | Manufacturer, Specification developer | 11 | November 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tricol Biomedical, INC. | Portland, OR, United States | Specification developer | 6 | November 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 5 | December 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 5 | December 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Z-Medica, LLC | North Haven, CT, United States | Manufacturer, Repackager or relabeler | 5 | December 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Z-Medica, LLC | Wallingford, CT, United States | Manufacturer, Repackager or relabeler | 5 | December 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Lifescience Plus, Inc. | Mountain View, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biolife, LLC | Sarasota, FL, United States | Manufacturer | 3 | July 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| Hemostasis, LLC | Saint Paul, MN, United States | Manufacturer | 3 | November 15, 2012 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 3 | July 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| Advamedica Inc. | Cambridge, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | April 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Chitogen Inc | Maple Grove, MN, United States | Manufacturer, Specification developer | 2 | August 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Core Scientific Creations Ltd | Petach Tikva Central, Israel | Manufacturer | 2 | August 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| Coreleader Biotech Co., Ltd | New Taipei City, Taiwan | Manufacturer | 2 | July 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| Cresilon Inc | Brooklyn, NY, United States | Manufacturer | 2 | December 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Zeo-Innov Life Technology Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 2 | May 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Starch Medical Inc. | San Jose, CA, United States | Complaint file establishment, Specification developer | 2 | March 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Advanced Vascular Dynamics | Tigard, OR, United States | Manufacturer | 1 | April 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| BC3 Technologies | Baltimore, MD, United States | Complaint file establishment, Specification developer | 1 | February 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bestreat Safety & First Aid Solution Co., Ltd | Wuhan Hubei, China | Manufacturer | 1 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Specification developer | 1 | August 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Beeken Biomedical LLC | Newton, MA, United States | Complaint file establishment, Specification developer | 1 | June 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Coag | Saint Paul, MN, United States | Manufacturer | 1 | July 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| Davol Inc. | Woburn, MA, United States | Manufacturer | 1 | December 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 1 | December 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Euroresearch S.R.L. | MILANO Lombardy, Italy | Manufacturer | 1 | July 22, 2005 | 0 | 0 | 0 | api.fda.gov |
| Huizhou Foryou Medical Devices Co.,ltd. | HuiZhou Guangdong, China | Manufacturer | 1 | May 23, 2012 | 0 | 0 | 0 | api.fda.gov |
| Identipak Inc. | McAllen, TX, United States | Manufacturer, Repackager or relabeler | 1 | October 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Newvalue Medical Products Co., Ltd. | Taizhou Jiangsu, China | Exporter to the US, Manufacturer | 1 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Koag International LLC | Vonore, TN, United States | Specification developer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Laboratoires Brothier, S.A. | FONTEVRAUD L ABBAYE Maine-et-Loire, France | Manufacturer | 1 | February 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Machina Medical Corporation | Roswell, GA, United States | Complaint file establishment, Specification developer | 1 | December 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medcura, Inc. (fka Gel-E, Inc.) | Riverdale, MD, United States | Complaint file establishment, Manufacturer | 1 | October 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Safeguard Medical Technologies Ltd | Hereford Herefordshire, United Kingdom | Specification developer | 1 | May 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sam Medical Products | Tualatin, OR, United States | Specification developer | 1 | May 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| SCL Science Inc. | Seoul, South Korea | Manufacturer | 1 | November 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Speciality Fibres and Materials Limited | Coventry, United Kingdom | Manufacturer | 1 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| T-Scientific International, Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Specification developer | 1 | April 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Tacmed Solutions, LLC | Anderson, SC, United States | Specification developer | 1 | August 25, 2009 | 0 | 0 | 0 | api.fda.gov |
| Taizhou Xinkang Medical Materials Co., Ltd | Taizhou Jiangsu, China | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | May 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| TZ Medical, Inc. | Tualatin, OR, United States | Manufacturer, Specification developer | 1 | May 11, 2004 | 0 | 0 | 0 | api.fda.gov |
| Unicare Biomedical, Inc. | Laguna Hills, CA, United States | Repackager or relabeler, Specification developer | 1 | November 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Acupac Packaging, Inc. | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aerosol And Liquid Packaging | Baltimore, MD, United States | 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 | |
| Beijing Huan Qiu Li Kang Biotech Co., Ltd. | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benefit Coatings, Inc. | Stratford, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benq Materials Corporation | Gueishan Taoyuan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Taikesiman Technology Development Co., LTD | Li Qiao Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davol Surgical Innovations | CD. JUAREZ Chihuahua, Mexico | 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 | |
| HCM Medical | Nijmegen Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horng Tzer Medical Instruments, Ltd. | Kaohsiung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipc Process-Center GMBH & Co. KG | Dresden Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivor Shaw, Ltd. | Derby, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovize | North Oaks, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jago-Pro SP. Z O.O. | JAWORZNO Slaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OVIK Health | Columbus, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmaplast S.A.E. | ALEXANDRIA Al Iskandariyah, Egypt | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vexxus Medical Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.