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Data / Medical devices / Drape, Surgical, Exempt / United States

FDA-registered makers of Drape, Surgical, Exempt in the United States: 80 establishments

80 establishments in the United States are registered with the FDA to make Drape, Surgical, Exempt (product code PUI). 0 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Drape, Surgical, Exempt
Product code
PUI
Country
United States

Makers of Drape, Surgical, Exempt in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
ADDEV Materials HealthcareMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Adroit Medical Systems, Inc.Loudon, TN, United StatesContract manufacturer0000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aerobiotix UsaMiamisburg, OH, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Atlanta Healthcare ServicesLawrenceville, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer0000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Auris Health, IncSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Auris Health, Inc.San Jose, CA, United StatesManufacturer0000api.fda.gov
Austin Medical, Inc.Waynesville, NC, United StatesManufacturer, Specification developer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Clear Guide MedicalBaltimore, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
CovidienNorth Haven, CT, United StatesSpecification developer0000api.fda.gov
Currie Medical, Inc.Franklin, TN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Currie Medical, Inc.Norfolk, VA, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Devicor Medical Products, Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Egg Medical, Inc.Roseville, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesManufacturer, Specification developer0000api.fda.gov
Flex Operating Room, IncFarmington, NY, United StatesSpecification developer0000api.fda.gov
Foothills Industries, Inc.Marion, NC, United StatesContract manufacturer0000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Hilo Industries LLCMesa, AZ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ig Holdings LLCEttrick, WI, United StatesContract manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Kent Elastomer Products, Inc.Kent, OH, United StatesContract manufacturer0000api.fda.gov
Kent Elastomer Products, Inc.Dundee, OH, United StatesContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesSpecification developer0000api.fda.gov
Medicalock CorporationEttrick, WI, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0050api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer0000api.fda.gov
MEDTRONIC NAVIGATION, INC. (Boxborough)Boxborough, MA, United StatesSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Mizuho Orthopedic Systems, Inc.Union City, CA, United StatesSpecification developer0000api.fda.gov
Manus Medical, LLCHenrico, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesManufacturer0000api.fda.gov
Microtek Medical LLCNorthfield, IL, United StatesSpecification developer0040api.fda.gov
Microtek Medical LLCAlpharetta, GA, United StatesSpecification developer0010api.fda.gov
Microtek Medical LLCTyler, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nexus CMFSalt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Operating Room Innovations, IncLa Jolla, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Or Specific, Inc.Vancouver, WA, United StatesSpecification developer0000api.fda.gov
Pedigo Products, Inc.Vancouver, WA, United StatesSpecification developer0000api.fda.gov
Polk Vocational ServicesColumbus, NC, United StatesContract manufacturer0000api.fda.gov
Protech Leaded Eyewear, Inc.West Palm Beach, FL, United StatesSpecification developer0000api.fda.gov
Rac Medical SolutionsBruceton, TN, United StatesManufacturer0000api.fda.gov
Radux Devices IncFridley, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Surgibox IncCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer0000api.fda.gov
Strukmyer MedicalMesquite, TX, United StatesContract manufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesSpecification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
Uroviu CorporationLos Altos, CA, United StatesSpecification developer0000api.fda.gov
Variamed, L.L.C.Chattanooga, TN, United StatesSpecification developer0000api.fda.gov
Viscot Medical LLCDenville, NJ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Vital Care Industries, LLC.Tinley Park, IL, United StatesSpecification developer0000api.fda.gov
Viant San Antonio, Inc.San Antonio, TX, United StatesContract manufacturer0000api.fda.gov
WEG Surgical SolutionsGreensboro, NC, United StatesSpecification developer0000api.fda.gov
Worldwide Innovations & Technologies, Inc.Lenexa, KS, United StatesManufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.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.