Skip to the page

Data / Medical devices / Dressing, Wound, Hydrogel Without Drug And/Or Biologic / United States

FDA-registered makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic in the United States: 60 establishments

60 establishments in the United States are registered with the FDA to make Dressing, Wound, Hydrogel Without Drug And/Or Biologic (product code NAE). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 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.

Device
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Product code
NAE
Country
United States

Makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1May 12, 1993000api.fda.gov
Cardinal HealthChicopee, MA, United StatesContract manufacturer, Manufacturer1August 23, 1995000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1August 23, 1995000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1May 12, 1993000api.fda.gov
Accupac, LLCMainland, PA, United StatesContract manufacturer0000api.fda.gov
Arch TherapeuticsFramingham, MA, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesManufacturer0000api.fda.gov
Astute Choice PackagingHenrico, VA, United StatesManufacturer0000api.fda.gov
Altrazeal Life Sciences Inc.Addison, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Attwill Medical SolutionsLodi, WI, United StatesSpecification developer0000api.fda.gov
Bellus Medical, LLCJohnson City, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Biomed Laboratories LLCDallas, TX, United StatesContract manufacturer0000api.fda.gov
C.G. Laboratories-Bob WhiteGranbury, TX, United StatesContract manufacturer0000api.fda.gov
CG Converting And Packaging, LLCGranbury, TX, United StatesContract manufacturer0000api.fda.gov
Crown Laboratories, Inc.Johnson City, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Cup Pac Packaging, Inc.South Beloit, IL, United StatesContract manufacturer0000api.fda.gov
Curapep LLCBurlington, WI, United StatesSpecification developer0000api.fda.gov
Colgate-Palmolive CompanyPiscataway, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ConvaTec, Inc.Greensboro, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Custom Medical and Safety Products Inc.Buffalo, NY, United StatesSpecification developer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Focus Health GroupKnoxville, TN, United StatesSpecification developer0000api.fda.gov
Focus Medical, LLC.Bethel, CT, United StatesManufacturer0000api.fda.gov
Genadyne Biotechnologies, Inc.Hicksville, NY, United StatesSpecification developer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
GelSana Therapeutics, Inc.Aurora, CO, United StatesManufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Implus Footcare LLCDurham, NC, United StatesSpecification developer0000api.fda.gov
Kericure MedicalLand O Lakes, FL, United StatesSpecification developer0000api.fda.gov
Lavior Pharma Inc.Hallandale Beach, FL, United StatesSpecification developer0000api.fda.gov
LC CellSarasota, FL, United StatesManufacturer0000api.fda.gov
Marian MonticelloMonticello, IN, United StatesContract manufacturer0000api.fda.gov
Mccord ResearchNorth Liberty, IA, United StatesSpecification developer0000api.fda.gov
MCMPArlington, TX, United StatesManufacturer0000api.fda.gov
Med Way Inc.Buford, GA, United StatesManufacturer0000api.fda.gov
Medi-Dyne Healthcare Products, Inc.Colleyville, TX, United StatesSpecification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MPM MedicalMesquite, TX, United StatesSpecification developer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Neilmed Pharmaceuticals, Inc.Santa Rosa, CA, United StatesManufacturer0000api.fda.gov
Nexgel, Inc.Langhorne, PA, United StatesManufacturer0000api.fda.gov
Orthonu, LLCRumson, NJ, United StatesManufacturer0000api.fda.gov
Parker Laboratories, Inc.Fairfield, NJ, United StatesContract manufacturer0000api.fda.gov
Philip A Marraccini, M.D.Harrison, NY, United StatesSpecification developer0000api.fda.gov
Polymer Science, Inc.Monticello, IN, United StatesContract manufacturer0000api.fda.gov
Progressive Wound Care Technologies, LLCSavannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pure Source, LLCDoral, FL, United StatesContract manufacturer, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Redicare LLCCongers, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer0010api.fda.gov
Safeguard Us Operating, LLCHuntersville, NC, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Sarasota Medical ProductsSarasota, FL, United StatesContract manufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
SPAN PACKAGING SERVICES d.b.a. MULTI-PACK SOLUTIONSGreenville, SC, United StatesContract manufacturer0000api.fda.gov
Star Port IncDenver, CO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Strukmyer MedicalMesquite, TX, United StatesContract manufacturer0000api.fda.gov
Swiss-American CDMO,LLCCarrollton, TX, United StatesContract manufacturer0000api.fda.gov
Wasatch Product Development, LLCDraper, UT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Water-Jel Technologies, LLCHuntersville, NC, United StatesManufacturer0000api.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.