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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

CountryMakers
United States13
China6
Canada2
Israel1
Cambodia1
Guatemala1
Dominican Republic1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Derma Sciences Canada, IncTORONTO Ontario, CanadaManufacturer3April 29, 1998000api.fda.gov
Mcneil Healthcare LLCFairfield, NJ, United StatesContract manufacturer, Manufacturer, Repackager or relabeler3January 31, 1994000api.fda.gov
Derma Sciences Nantong IncorporationDEVELOPMENT Jiangsu, ChinaContract manufacturer, Manufacturer2April 29, 1998000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelSpecification developer2September 16, 1980000api.fda.gov
A Plus International, IncChino, CA, United StatesRepackager or relabeler, Specification developer1April 28, 1988000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Repackager or relabeler, Specification developer1June 2, 1983010api.fda.gov
Carwild Corp.New London, CT, United StatesSpecification developer1November 5, 1979000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1December 31, 1997000api.fda.gov
Cardinal HealthAugusta, GA, United StatesManufacturer1December 31, 1997000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer1April 15, 1986000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1August 12, 1999000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1November 5, 1979020api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesSpecification developer1February 13, 1998000api.fda.gov
Allmed Medical Products Co., Ltd.Zhijiang City Hubei, ChinaContract manufacturer0000api.fda.gov
Allmed Medical Products Co., Ltd.ZHIJIANG CITY Hubei, ChinaContract manufacturer0000api.fda.gov
Anqing Aijing Textile Co., Ltd.AnQing City Anhui, ChinaContract manufacturer0000api.fda.gov
Cam A P I Medical Co., Ltd.Angsnuol District Kandal, CambodiaContract manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hydrofera, LLC.Manchester, CT, United StatesContract manufacturer0000api.fda.gov
Jianerkang Medical Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Medtronic Xomed, Inc.Mystic, CT, United StatesManufacturer0000api.fda.gov
Omt, LLCFort Lauderdale, FL, United StatesSpecification developer0000api.fda.gov
Suzhou Avon Textile Co., Ltd.Suzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.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.