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Data / Medical devices / Mask, Surgical / United States

FDA-registered makers of Mask, Surgical in the United States: 51 establishments

51 establishments in the United States are registered with the FDA to make Mask, Surgical (product code FXX). 49 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Mask, Surgical
Product code
FXX
Country
United States

Makers of Mask, Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer30March 18, 2026000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer7July 3, 2023000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesManufacturer, Specification developer4February 14, 1989000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesSpecification developer4March 28, 1994000api.fda.gov
Crosstex InternationalRush, NY, United StatesManufacturer, Repackager or relabeler4June 22, 2015000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer4August 17, 2022000api.fda.gov
Armbrust Inc.Elgin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3January 26, 2022000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer3February 16, 2021000api.fda.gov
O&M Halyard, Inc. (La Ada de Acuna)Del Rio, TX, United StatesManufacturer3May 30, 2025000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesContract manufacturer, Manufacturer3August 15, 2017000api.fda.gov
A Plus International, IncChino, CA, United StatesSpecification developer2May 11, 2022000api.fda.gov
Altor SafetyValley Cottage, NY, United StatesManufacturer2September 3, 2021000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer2August 14, 2006000api.fda.gov
PremiumEStore LLC, d.b.a. Premium-PPEVirginia Beach, VA, United StatesManufacturer2June 15, 2021000api.fda.gov
Safesource DirectBroussard, LA, United StatesManufacturer2March 8, 2023000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer2September 11, 2019000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer2September 11, 2019000api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesRepackager or relabeler, Specification developer2March 24, 2022000api.fda.gov
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer1May 1, 1996000api.fda.gov
3M CompanyValley, NE, United StatesManufacturer1May 1, 1996000api.fda.gov
3M CompanyAberdeen, SD, United StatesManufacturer1May 1, 1996000api.fda.gov
Angstrom MFG., Inc.Sainte Genevieve, MO, United StatesContract manufacturer, Manufacturer1March 25, 2021000api.fda.gov
Anzen HealthChicago, IL, United StatesSpecification developer1January 24, 2019000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1November 3, 1989000api.fda.gov
Apex Aseptic ProductsVoorhees, NJ, United StatesSpecification developer1June 7, 2004000api.fda.gov
Baylab UsaDallas, TX, United StatesManufacturer1December 7, 2021000api.fda.gov
Berkley Medical Resources, Inc.Smithfield, PA, United StatesContract manufacturer, Manufacturer1October 23, 1992000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler1November 2, 1994000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer1November 30, 1993000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer1July 24, 2020000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer1August 14, 2006000api.fda.gov
Ecoguard IncGrover, NC, United StatesManufacturer1February 2, 2021000api.fda.gov
Efofex, Inc.Rogers, AR, United StatesManufacturer1March 27, 2023000api.fda.gov
Hygenix Health Solutions LLCTorrance, CA, United StatesManufacturer1December 11, 2023000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer1August 16, 2010000api.fda.gov
Iris Usa IncPleasant Prairie, WI, United StatesManufacturer1August 3, 2023000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1March 24, 2023000api.fda.gov
Mexpo International, Inc.Union City, CA, United StatesContract manufacturer, Specification developer1April 23, 2020000api.fda.gov
Mid-America Safety CorpElk Grove Village, IL, United StatesManufacturer1July 25, 2021000api.fda.gov
Magicare Tech CorpOntario, CA, United StatesManufacturer1August 11, 2021000api.fda.gov
Medline Industries, LP - Lithia SpringsLithia Springs, GA, United StatesManufacturer1March 24, 2023000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer1June 22, 2015000api.fda.gov
New York Embroidery StudioBrooklyn, NY, United StatesContract manufacturer, Manufacturer1May 13, 2021000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer1January 24, 2019000api.fda.gov
Proguard Health Inc.Los Angeles, CA, United StatesSpecification developer1November 4, 2022000api.fda.gov
ReMadeUSA - BakersfieldBakersfield, CA, United StatesManufacturer1September 10, 2021000api.fda.gov
Syntech, Int'l Inc.Irvine, CA, United StatesContract manufacturer, Manufacturer1July 8, 1988000api.fda.gov
StringKingCarson, CA, United StatesManufacturer1April 23, 2021000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1July 8, 1988000api.fda.gov
Healthplus, LLCAsheville, NC, United StatesContract manufacturer0000api.fda.gov
United Medical Enterprise, Inc.Thomson, GA, United StatesContract manufacturer0000api.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.