Data / Medical devices / Gauze/Sponge, Internal / United States
FDA-registered makers of Gauze/Sponge, Internal in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Gauze/Sponge, Internal (product code EFQ). 9 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
- Gauze/Sponge, Internal
- Product code
- EFQ
- Country
- United States
Makers of Gauze/Sponge, Internal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mcneil Healthcare LLC | Fairfield, NJ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | January 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| A Plus International, Inc | Chino, CA, United States | Repackager or relabeler, Specification developer | 1 | April 28, 1988 | 0 | 0 | 0 | api.fda.gov |
| Carwild Corp. | New London, CT, United States | Specification developer | 1 | November 5, 1979 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | December 31, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Augusta, GA, United States | Manufacturer | 1 | December 31, 1997 | 0 | 0 | 0 | api.fda.gov |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 1 | April 15, 1986 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | August 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | November 5, 1979 | 0 | 2 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Specification developer | 1 | February 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Hydrofera, LLC. | Manchester, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Mystic, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omt, LLC | Fort Lauderdale, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 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.