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.
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- 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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | May 12, 1993 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Chicopee, MA, United States | Contract manufacturer, Manufacturer | 1 | August 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | August 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | May 12, 1993 | 0 | 0 | 0 | api.fda.gov |
| Accupac, LLC | Mainland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arch Therapeutics | Framingham, MA, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Astute Choice Packaging | Henrico, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altrazeal Life Sciences Inc. | Addison, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Attwill Medical Solutions | Lodi, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bellus Medical, LLC | Johnson City, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomed Laboratories LLC | Dallas, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.G. Laboratories-Bob White | Granbury, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CG Converting And Packaging, LLC | Granbury, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Laboratories, Inc. | Johnson City, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cup Pac Packaging, Inc. | South Beloit, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curapep LLC | Burlington, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Colgate-Palmolive Company | Piscataway, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec, Inc. | Greensboro, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Custom Medical and Safety Products Inc. | Buffalo, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Focus Health Group | Knoxville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Focus Medical, LLC. | Bethel, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genadyne Biotechnologies, Inc. | Hicksville, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GelSana Therapeutics, Inc. | Aurora, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implus Footcare LLC | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kericure Medical | Land O Lakes, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lavior Pharma Inc. | Hallandale Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LC Cell | Sarasota, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marian Monticello | Monticello, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mccord Research | North Liberty, IA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MCMP | Arlington, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med Way Inc. | Buford, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi-Dyne Healthcare Products, Inc. | Colleyville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MPM Medical | Mesquite, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neilmed Pharmaceuticals, Inc. | Santa Rosa, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexgel, Inc. | Langhorne, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthonu, LLC | Rumson, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parker Laboratories, Inc. | Fairfield, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philip A Marraccini, M.D. | Harrison, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymer Science, Inc. | Monticello, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Progressive Wound Care Technologies, LLC | Savannah, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pure Source, LLC | Doral, FL, United States | Contract manufacturer, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Redicare LLC | Congers, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safe N Simple LLC | Clarkston, MI, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Safeguard Us Operating, LLC | Huntersville, NC, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarasota Medical Products | Sarasota, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPAN PACKAGING SERVICES d.b.a. MULTI-PACK SOLUTIONS | Greenville, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Star Port Inc | Denver, CO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strukmyer Medical | Mesquite, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swiss-American CDMO,LLC | Carrollton, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wasatch Product Development, LLC | Draper, UT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Water-Jel Technologies, LLC | Huntersville, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.