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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Viscot Medical LLCDenville, NJ, United StatesManufacturer, Repackager or relabeler5February 3, 1994000api.fda.gov
American Surgical Company, LLCBeverly, MA, United StatesManufacturer1December 17, 1985010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler1June 14, 1978041api.fda.gov
Carefree Surgical Specialties, Inc.Nampa, ID, United StatesSpecification developer1August 3, 1988010api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Manufacturer, Specification developer1August 7, 1981000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1February 22, 1996000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1July 23, 1992000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1July 23, 1992000api.fda.gov
A Plus International, IncChino, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer, Specification developer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal HealthAugusta, GA, United StatesManufacturer0010api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
Hydrofera, LLC.Manchester, CT, United StatesContract manufacturer0000api.fda.gov
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Mcneil Healthcare LLCFairfield, NJ, United StatesContract manufacturer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesManufacturer, Repackager or relabeler0030api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
North American Rescue, LLC.Greer, SC, United StatesSpecification developer0000api.fda.gov
Omt, LLCFort Lauderdale, FL, United StatesSpecification developer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Tally Surgical, Inc.Aliso Viejo, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
U.S. Surgitech, Inc.Carol Stream, IL, United StatesSpecification developer0000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesSpecification developer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer0000api.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.