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

FDA-registered makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics in the United States: 35 establishments

35 establishments in the United States are registered with the FDA to make Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY). 27 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Product code
QSY
Country
United States

Makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
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
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
Cresilon IncBrooklyn, NY, United StatesManufacturer2December 12, 2025000api.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
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
Identipak Inc.McAllen, TX, United StatesManufacturer, Repackager or relabeler1October 25, 2019000api.fda.gov
Koag International LLCVonore, TN, United StatesSpecification developer1July 29, 2022000api.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
Sam Medical ProductsTualatin, OR, United StatesSpecification developer1May 22, 2014000api.fda.gov
Tacmed Solutions, LLCAnderson, SC, United StatesSpecification developer1August 25, 2009000api.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
Benefit Coatings, Inc.Stratford, CT, United StatesContract manufacturer0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
OVIK HealthColumbus, NC, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.