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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ADDEV Materials Healthcare | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Adroit Medical Systems, Inc. | Loudon, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aerobiotix Usa | Miamisburg, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atlanta Healthcare Services | Lawrenceville, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auris Health, Inc | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auris Health, Inc. | San Jose, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Austin Medical, Inc. | Waynesville, NC, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Repackager or relabeler, Specification developer | 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 | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clear Guide Medical | Baltimore, MD, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | North Haven, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currie Medical, Inc. | Franklin, TN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currie Medical, Inc. | Norfolk, VA, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Devicor Medical Products, Inc. | Cincinnati, OH, 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. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Egg Medical, Inc. | Roseville, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Group, LLC. | McDonough, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex Operating Room, Inc | Farmington, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foothills Industries, Inc. | Marion, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Footprint Medical Inc. | San Antonio, TX, 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 | |
| Grace Medical, Inc. | Memphis, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilo Industries LLC | Mesa, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ig Holdings LLC | Ettrick, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Elastomer Products, Inc. | Kent, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Elastomer Products, Inc. | Dundee, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicalock Corporation | Ettrick, WI, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 5 | 0 | api.fda.gov | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDTRONIC NAVIGATION, INC. (Boxborough) | Boxborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mizuho Orthopedic Systems, Inc. | Union City, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manus Medical, LLC | Henrico, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Eagan, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Northfield, IL, United States | Specification developer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Microtek Medical LLC | Alpharetta, GA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Microtek Medical LLC | Tyler, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus CMF | Salt Lake City, UT, United States | Complaint file establishment, 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 | |
| Operating Room Innovations, Inc | La Jolla, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Or Specific, Inc. | Vancouver, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pedigo Products, Inc. | Vancouver, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polk Vocational Services | Columbus, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protech Leaded Eyewear, Inc. | West Palm Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rac Medical Solutions | Bruceton, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radux Devices Inc | Fridley, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Standard Textile Co., Inc. | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgibox Inc | Cambridge, MA, United States | Complaint file establishment, Specification developer | 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 | |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strukmyer Medical | Mesquite, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, 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 | |
| Uroviu Corporation | Los Altos, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Variamed, L.L.C. | Chattanooga, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viscot Medical LLC | Denville, NJ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vital Care Industries, LLC. | Tinley Park, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant San Antonio, Inc. | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WEG Surgical Solutions | Greensboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Worldwide Innovations & Technologies, Inc. | Lenexa, KS, 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 |
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.