Data / Medical devices / Gauze/Sponge, Internal
Gauze/Sponge, Internal (EFQ): 25 FDA-registered makers in 7 countries
25 establishments in 7 countries are registered with the FDA to make Gauze/Sponge, Internal (product code EFQ, Class U). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 271 510(k) clearances under this code, the latest on August 12, 1999, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EFQ
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| China | 6 |
| Canada | 2 |
| Israel | 1 |
| Cambodia | 1 |
| Guatemala | 1 |
| Dominican Republic | 1 |
Makers of Gauze/Sponge, Internal
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Derma Sciences Canada, Inc | TORONTO Ontario, Canada | Manufacturer | 3 | April 29, 1998 | 0 | 0 | 0 | api.fda.gov |
| Mcneil Healthcare LLC | Fairfield, NJ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | January 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| Derma Sciences Nantong Incorporation | DEVELOPMENT Jiangsu, China | Contract manufacturer, Manufacturer | 2 | April 29, 1998 | 0 | 0 | 0 | api.fda.gov |
| Euroband Bioline LTD. | INDUSTRIAL PARK EMEK HEFER Central, Israel | Specification developer | 2 | September 16, 1980 | 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 |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | June 2, 1983 | 0 | 1 | 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 |
| Allmed Medical Products Co., Ltd. | Zhijiang City Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmed Medical Products Co., Ltd. | ZHIJIANG CITY Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Aijing Textile Co., Ltd. | AnQing City Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cam A P I Medical Co., Ltd. | Angsnuol District Kandal, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hydrofera, LLC. | Manchester, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jianerkang Medical Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | 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 | |
| Suzhou Avon Textile Co., Ltd. | Suzhou City Jiangsu, China | Contract manufacturer | 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 August 12, 1999. 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.