Data / Medical devices / Accessory, Surgical Apparel / United States
FDA-registered makers of Accessory, Surgical Apparel in the United States: 94 establishments
94 establishments in the United States are registered with the FDA to make Accessory, Surgical Apparel (product code LYU). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Accessory, Surgical Apparel
- Product code
- LYU
- Country
- United States
Makers of Accessory, Surgical Apparel in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 3 | December 2, 1991 | 0 | 0 | 0 | api.fda.gov |
| Wells Lamont Industrial, LLC | Philadelphia, MS, United States | Manufacturer | 3 | April 10, 1995 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | July 19, 1994 | 0 | 0 | 0 | api.fda.gov |
| Embrace Healthcare LLC | Nashua, NH, United States | Manufacturer | 1 | July 19, 1994 | 0 | 0 | 0 | api.fda.gov |
| Microtek Medical LLC | Eagan, MN, United States | Specification developer | 1 | December 2, 1991 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | June 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| A-dec, Inc. | Newberg, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allcare, Inc. | St Charles, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphaprotech, Inc. | Nogales, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Dawn Inc. | Compton, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Hospital Supply | Santa Monica, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Healthcare Products LLC | Reno, NV, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arbill Industries, Inc. | Phila, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Astute Choice Packaging | Henrico, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Aseptic Products | Voorhees, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bags And Wraps Etc., Inc. | Honolulu, HI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brownmed | Spirit Lake, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cellucap Manufacturing Co. | Phila, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cliktech, LLC. | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Haverhill, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curt G. Joa, Inc. | Sheboygan Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DOMA Patient Safety Products, LLC | Santa Paula, CA, 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 | |
| DeRoyal Industries, Inc. | Powell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | Powell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Group, LLC. | McDonough, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evans Manufacturing | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GD Group USA Company | Bartlett, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gilero, Inc | Pittsboro, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HPK Industries | Frankfort, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Halyard North Carolina, LLC | Linwood, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intec Industries, Inc. | Birmingham, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventive Resources, Inc | Salida, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itech | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K2 Health Products | Brooklyn, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Molded Products Inc. | Harlan, IA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oakley, Inc. | Foothill Ranch, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ouachita Contract Manufacturing, LLC | Monroe, LA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polyconversions, Inc. | Champaign, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Practicon, Inc. | Greenville, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prestige Ameritech | North Richland Hills, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primex Design & Fabrication | Richmond, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Dallas, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Duncanville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.H. Cross Enterprises, Inc. | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rosemarie Products Company, LLC | Mason, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rapid Aid Corp. | Moberly, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safer Medical Products | Fircrest, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secured Ortho Manufacturing Of America, LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sloan Medical | Omaha, NE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TC Dental & Medical Supplies, Inc. | Anaheim, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Transparent Supply Solutions Ltd. | Dover, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Argen Corporation | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Surgitech, Inc. | Carol Stream, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultralight Optics Inc. | Westminster, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Western Industries Corporation | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wolf X-Ray Corp | Battleboro, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WPT Corporation | Beaver Dam, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welmed, Inc. | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xodus Medical, Inc. | New Kensington, PA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Innovations Inc. | Algonquin, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zinnanti Surgical Design Group Inc | Santa Cruz, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zurich Medical Inc | Plymouth, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.