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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer3December 2, 1991000api.fda.gov
Wells Lamont Industrial, LLCPhiladelphia, MS, United StatesManufacturer3April 10, 1995000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1July 19, 1994000api.fda.gov
Embrace Healthcare LLCNashua, NH, United StatesManufacturer1July 19, 1994000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer1December 2, 1991000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1June 22, 2001000api.fda.gov
A-dec, Inc.Newberg, OR, United StatesManufacturer0000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesSpecification developer0000api.fda.gov
American Dawn Inc.Compton, CA, United StatesSpecification developer0000api.fda.gov
American Hospital SupplySanta Monica, CA, United StatesSpecification developer0000api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesManufacturer, Specification developer0000api.fda.gov
Arbill Industries, Inc.Phila, PA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer, Specification developer0000api.fda.gov
Astute Choice PackagingHenrico, VA, United StatesManufacturer0000api.fda.gov
Apex Aseptic ProductsVoorhees, NJ, United StatesSpecification developer0000api.fda.gov
Bags And Wraps Etc., Inc.Honolulu, HI, United StatesSpecification developer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesManufacturer, Specification developer0000api.fda.gov
BrownmedSpirit Lake, IA, United StatesManufacturer0000api.fda.gov
Cellucap Manufacturing Co.Phila, PA, United StatesSpecification developer0000api.fda.gov
Cliktech, LLC.Scottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Curt G. Joa, Inc.Sheboygan Falls, WI, United StatesContract manufacturer0000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
DOMA Patient Safety Products, LLCSanta Paula, CA, United StatesSpecification developer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DeRoyal Industries, Inc.Powell, TN, United StatesContract manufacturer0000api.fda.gov
DeRoyal Industries, Inc.Powell, TN, United StatesContract manufacturer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Evans ManufacturingGarden Grove, CA, United StatesManufacturer0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
Gilero, IncPittsboro, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
HPK IndustriesFrankfort, NY, United StatesManufacturer0000api.fda.gov
Halyard North Carolina, LLCLinwood, NC, United StatesManufacturer0000api.fda.gov
Intec Industries, Inc.Birmingham, AL, United StatesContract manufacturer0000api.fda.gov
Inventive Resources, IncSalida, CA, United StatesManufacturer, Specification developer0000api.fda.gov
ItechSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc.Auburn Hills, MI, United StatesContract manufacturer0000api.fda.gov
K2 Health ProductsBrooklyn, NY, United StatesSpecification developer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0020api.fda.gov
Molded Products Inc.Harlan, IA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Oakley, Inc.Foothill Ranch, CA, United StatesManufacturer0000api.fda.gov
Ouachita Contract Manufacturing, LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Polyconversions, Inc.Champaign, IL, United StatesManufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Primex Design & FabricationRichmond, IN, United StatesManufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer0000api.fda.gov
Quality Aspirators, Inc.Dallas, TX, United StatesManufacturer0000api.fda.gov
Quality Aspirators, Inc.Duncanville, TX, United StatesManufacturer0000api.fda.gov
R.H. Cross Enterprises, Inc.Portage, MI, United StatesContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Rosemarie Products Company, LLCMason, OH, United StatesSpecification developer0000api.fda.gov
Rapid Aid Corp.Moberly, MO, United StatesManufacturer0000api.fda.gov
Safer Medical ProductsFircrest, WA, United StatesSpecification developer0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sloan MedicalOmaha, NE, United StatesManufacturer, Specification developer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
TC Dental & Medical Supplies, Inc.Anaheim, CA, United StatesSpecification developer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesManufacturer0000api.fda.gov
U.S. Surgitech, Inc.Carol Stream, IL, United StatesSpecification developer0000api.fda.gov
Ultralight Optics Inc.Westminster, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Western Industries CorporationOklahoma City, OK, United StatesManufacturer0000api.fda.gov
Wolf X-Ray CorpBattleboro, NC, United StatesManufacturer0000api.fda.gov
WPT CorporationBeaver Dam, KY, United StatesManufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesSpecification developer0000api.fda.gov
Zinnanti Surgical Design Group IncSanta Cruz, CA, United StatesSpecification developer0000api.fda.gov
Zurich Medical IncPlymouth, MN, United StatesManufacturer0000api.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.