Data / Medical devices / Gauze/Sponge, Internal, X-Ray Detectable / United States
FDA-registered makers of Gauze/Sponge, Internal, X-Ray Detectable in the United States: 36 establishments
36 establishments in the United States are registered with the FDA to make Gauze/Sponge, Internal, X-Ray Detectable (product code GDY). 8 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Gauze/Sponge, Internal, X-Ray Detectable
- Product code
- GDY
- Country
- United States
Makers of Gauze/Sponge, Internal, X-Ray Detectable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Viscot Medical LLC | Denville, NJ, United States | Manufacturer, Repackager or relabeler | 5 | February 3, 1994 | 0 | 0 | 0 | api.fda.gov |
| American Surgical Company, LLC | Beverly, MA, United States | Manufacturer | 1 | December 17, 1985 | 0 | 1 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 1 | June 14, 1978 | 0 | 4 | 1 | api.fda.gov |
| Carefree Surgical Specialties, Inc. | Nampa, ID, United States | Specification developer | 1 | August 3, 1988 | 0 | 1 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 7, 1981 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | February 22, 1996 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | July 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | July 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| A Plus International, Inc | Chino, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allcare, Inc. | St Charles, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Manufacturer, 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 | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer, 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 | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Augusta, GA, United States | Manufacturer | 0 | 0 | 1 | 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 | |
| GD Group USA Company | Bartlett, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hydrofera, LLC. | Manchester, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Sterling Industries LLC | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcneil Healthcare LLC | Fairfield, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 3 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| North American Rescue, LLC. | Greer, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omt, LLC | Fort Lauderdale, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, 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 | |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterling Medical Products | Prophetstown, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tally Surgical, Inc. | Aliso Viejo, CA, United States | Complaint file establishment, Manufacturer, 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 | |
| U.S. Surgitech, Inc. | Carol Stream, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xodus Medical, Inc. | New Kensington, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zien Medical Technologies LLC | Salt Lake City, UT, 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.