Skip to the page
Get started free

Data / Medical devices / Dressing, Wound, Drug / United States

FDA-registered makers of Dressing, Wound, Drug in the United States: 116 establishments

116 establishments in the United States are registered with the FDA to make Dressing, Wound, Drug (product code FRO). 84 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
Dressing, Wound, Drug
Product code
FRO
Country
United States

Makers of Dressing, Wound, Drug in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer33September 13, 2024030api.fda.gov
ARGENTUM MEDICAL, LLC dba Bravida MedicalGeneva, IL, United StatesContract manufacturer, Manufacturer13July 31, 2024000api.fda.gov
Sonoma Pharmaceuticals, Inc.Boulder, CO, United StatesComplaint file establishment, Manufacturer, Specification developer12September 13, 2024030api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer10July 2, 2018000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer, Specification developer9May 24, 2024000api.fda.gov
Focus Health GroupKnoxville, TN, United StatesSpecification developer8December 16, 2024000api.fda.gov
Acell, Inc.Columbia, MD, United StatesSpecification developer6November 19, 2015000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer6February 26, 2009000api.fda.gov
Rochal Technologies LLCSan Antonio, TX, United StatesSpecification developer6March 30, 2023000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesManufacturer, Specification developer5December 10, 2018000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer5March 16, 2023000api.fda.gov
ABL Medical, LLCAmerican Fork, UT, United StatesComplaint file establishment, Specification developer4February 5, 2016000api.fda.gov
Cardinal HealthAugusta, GA, United StatesManufacturer4February 26, 2009000api.fda.gov
MPM MedicalMesquite, TX, United StatesSpecification developer4January 4, 2024000api.fda.gov
OVIK HealthSpartanburg, SC, United StatesSpecification developer4January 21, 2011000api.fda.gov
Resilia Pharmaceuticals, Inc.Atlanta, GA, United StatesSpecification developer4August 22, 2017000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Manufacturer, Specification developer4September 4, 2020000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer4October 10, 2025000api.fda.gov
Biowound SolutionsLas Vegas, NV, United StatesRepackager or relabeler, Specification developer3December 16, 2024000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler3November 21, 2017000api.fda.gov
Hydrofera, LLC.Manchester, CT, United StatesManufacturer3November 6, 2019000api.fda.gov
Innovacyn, Inc.Rialto, CA, United StatesManufacturer3January 5, 2026000api.fda.gov
Links Medical Products, Inc.Scottsdale, AZ, United StatesSpecification developer3May 2, 2014000api.fda.gov
Magic Science Supply LLCEdina, MN, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer3August 17, 2018000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer3September 4, 2020000api.fda.gov
URGO Medical North America, LLCFort Worth, TX, United StatesManufacturer, Specification developer3May 14, 2015000api.fda.gov
Anexa Biomedical, Inc.North Richland Hills, TX, United StatesManufacturer2September 21, 2017000api.fda.gov
Bionova Medical, Inc.Germantown, TN, United StatesSpecification developer2October 31, 2024000api.fda.gov
Century Pharmaceuticals, Inc.Indianapolis, IN, United StatesComplaint file establishment, Manufacturer2July 21, 2016000api.fda.gov
Dynarex Corp.Middletown, NY, United StatesSpecification developer2October 3, 2016000api.fda.gov
Ferris MFG. Corp.Fort Worth, TX, United StatesManufacturer2October 22, 2003000api.fda.gov
Hedonist Biochemical Technologies (usa), Inc.Plano, TX, United StatesSpecification developer2July 7, 2004000api.fda.gov
Imbed Biosciences Inc.Middleton, WI, United StatesComplaint file establishment, Manufacturer2October 17, 2024000api.fda.gov
Physician Recommended Nutriceuticals PRNBlue Bell, PA, United StatesComplaint file establishment, Specification developer2July 24, 2013000api.fda.gov
Primus Pharmaceuticals, Inc.Scottsdale, AZ, United StatesSpecification developer2October 11, 2006000api.fda.gov
Seriously Clean LtdNixa, MO, United StatesManufacturer2May 2, 2025000api.fda.gov
SiOxMed, LLCWinston Salem, NC, United StatesComplaint file establishment, Manufacturer2January 12, 2026000api.fda.gov
Aim Medical IncWestwood, MA, United StatesSpecification developer1April 21, 2016000api.fda.gov
Arch TherapeuticsFramingham, MA, United StatesManufacturer, Specification developer1March 11, 2020000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesSpecification developer1March 27, 2001000api.fda.gov
Alliance Healing TechnologiesWaco, TX, United StatesSpecification developer1May 17, 2005000api.fda.gov
Amsino Healthcare (USA) Inc.Vernon Hills, IL, United StatesContract manufacturer, Manufacturer1April 14, 2021000api.fda.gov
Attwill Medical SolutionsLodi, WI, United StatesContract manufacturer, Manufacturer1September 3, 2020000api.fda.gov
Bio Med Sciences, Inc.Allentown, PA, United StatesSpecification developer1March 19, 1999000api.fda.gov
Biomed Laboratories LLCDallas, TX, United StatesContract manufacturer, Manufacturer1January 5, 2011000api.fda.gov
Church & Dwight Co., Inc.Princeton, NJ, United StatesComplaint file establishment, Specification developer1December 29, 2008000api.fda.gov
Cardinal HealthChicopee, MA, United StatesManufacturer1December 15, 1997000api.fda.gov
Clyra Medical Technologies, Inc.Tampa, FL, United StatesComplaint file establishment, Specification developer1September 20, 2019000api.fda.gov
Entrotech Life Sciences, LLCColumbus, OH, United StatesComplaint file establishment, Manufacturer, Specification developer1November 7, 2014000api.fda.gov
Gel4med, Inc.Lowell, MA, United StatesComplaint file establishment, Manufacturer, Specification developer1October 11, 2023000api.fda.gov
Innovacorium IncGainesville, FL, United StatesManufacturer1April 7, 2026000api.fda.gov
Irrimax CorporationLawrenceville, GA, United StatesComplaint file establishment, Specification developer1June 18, 2024000api.fda.gov
Integra LifeSciences Braintree Inc.Braintree, MA, United StatesManufacturer1December 10, 2010000api.fda.gov
Journey Medical CorporationScottsdale, AZ, United StatesManufacturer1May 1, 2013000api.fda.gov
Kericure MedicalLand O Lakes, FL, United StatesSpecification developer1July 18, 2024000api.fda.gov
KX Medical, Inc.Gallatin, TN, United StatesContract manufacturer, Manufacturer1September 7, 2016000api.fda.gov
Keneric Healthcare LLCAllen, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1March 13, 2007000api.fda.gov
Links Medical Products, Inc.Irvine, CA, United StatesManufacturer1March 14, 2014000api.fda.gov
Marine Polymer Technologies, Inc.Topsfield, MA, United StatesManufacturer1July 28, 2010000api.fda.gov
Mebo Life Science IncorporationBrea, CA, United StatesSpecification developer1October 18, 2022000api.fda.gov
Medipurpose, Inc.Duluth, GA, United StatesSpecification developer1September 1, 2011000api.fda.gov
Medline Industries, LPNorristown, PA, United StatesManufacturer1March 26, 2024000api.fda.gov
Neilmed Pharmaceuticals, Inc.Santa Rosa, CA, United StatesManufacturer, Repackager or relabeler1October 29, 2013000api.fda.gov
Newmedical Technology, Inc.Northbrook, IL, United StatesManufacturer1November 30, 2012000api.fda.gov
Nexgel, Inc.Langhorne, PA, United StatesManufacturer1August 22, 2017000api.fda.gov
Novabay Pharmaceuticals, IncEmeryville, CA, United StatesManufacturer1August 8, 2012000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer1December 18, 2008011api.fda.gov
Omeza, LLCSarasota, FL, United StatesManufacturer1September 1, 2021000api.fda.gov
Organogenesis Inc.Canton, MA, United StatesManufacturer1November 8, 2005000api.fda.gov
Progressive Wound Care Technologies, LLCSavannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer1March 12, 2013000api.fda.gov
Remedium Healthcare ProductsNorthbrook, IL, United StatesComplaint file establishment, Manufacturer, Specification developer1March 23, 2022000api.fda.gov
Sarasota Medical ProductsSarasota, FL, United StatesContract manufacturer, Manufacturer1November 27, 2015000api.fda.gov
Silk Holdings, Inc.Needham, MA, United StatesManufacturer1January 23, 2026000api.fda.gov
Silverceuticals IncLindon, UT, United StatesComplaint file establishment, Specification developer1June 24, 2026000api.fda.gov
Southwest Technologies, Inc.North Kansas City, MO, United StatesManufacturer1June 26, 1987020api.fda.gov
Stratus PharmaceuticalMiami, FL, United StatesSpecification developer1August 19, 2011000api.fda.gov
SweetbioMemphis, TN, United StatesRepackager or relabeler, Specification developer1October 13, 2023000api.fda.gov
Stedical ScientificCarlsbad, CA, United StatesSpecification developer1August 8, 2016000api.fda.gov
Strukmyer MedicalMesquite, TX, United StatesContract manufacturer, Specification developer1September 16, 2008000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1December 18, 2008000api.fda.gov
Swiss-American CDMO,LLCCarrollton, TX, United StatesContract manufacturer, Manufacturer1August 22, 2007000api.fda.gov
Taibo Medical Supply Inc.Las Vegas, NV, United StatesSpecification developer1June 1, 2015000api.fda.gov
Winchester Laboratories, LLLPDelray Beach, FL, United StatesSpecification developer1December 30, 1999000api.fda.gov
Wisconsin Pharmacal Co., LLCJackson, WI, United StatesContract manufacturer, Manufacturer1April 20, 2012000api.fda.gov
A-1 Creative Packaging LLCFort Atkinson, WI, United StatesContract manufacturer0000api.fda.gov
ABL Manufacturing, LLCAmerican Fork, UT, United StatesContract manufacturer0000api.fda.gov
Applied Laboratories, Inc.Columbus, IN, United StatesContract manufacturer0000api.fda.gov
Armis Biopharma, Inc.Fort Collins, CO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avita Medical Americas LLCVentura, CA, United StatesContract manufacturer0000api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
CG Converting And Packaging, LLCGranbury, TX, United StatesContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Chino, CA, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Dexios Services, LLC.Cornelius, NC, United StatesContract manufacturer0000api.fda.gov
Equipmed Usa LLCNewport Beach, CA, United StatesManufacturer for export0000api.fda.gov
FabriteqKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations, IncOntario, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations, Inc.Libertyville, IL, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Lavior Pharma Inc.Hallandale Beach, FL, United StatesManufacturer for export0000api.fda.gov
Lindo ManufacturingSwansea, MA, United StatesContract manufacturer0000api.fda.gov
Medline Industries - Arlington HeightsArlington Heights, IL, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Testing - CT, LLCWillington, CT, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Pure Source, LLCDoral, FL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Quality Bioresources, IncSeguin, TX, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Redi-2-Paq Home Products, LLCSarasota, FL, United StatesContract manufacturer0000api.fda.gov
Speciality Pharma MFGCarlstadt, NJ, United StatesContract manufacturer0000api.fda.gov
Scapa Tapes North America, LLCKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Tarmac Products, Inc.Miami Gardens, FL, United StatesContract manufacturer0000api.fda.gov
Ufp Technologies, Inc.Newburyport, MA, United StatesContract manufacturer0000api.fda.gov
Viscus Biologics, LLC.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.