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Data / Medical devices / Respirator, Surgical / United States

FDA-registered makers of Respirator, Surgical in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Respirator, Surgical (product code MSH). 11 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
Respirator, Surgical
Product code
MSH
Country
United States

Makers of Respirator, Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Moldex/Metric, Inc.Culver City, CA, United StatesManufacturer4September 13, 2010020api.fda.gov
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer2August 10, 2017000api.fda.gov
3M CompanyAberdeen, SD, United StatesManufacturer2August 10, 2017000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer2October 21, 2009000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2January 12, 2024000api.fda.gov
O&M Halyard, Inc. (La Ada de Acuna)Del Rio, TX, United StatesManufacturer2January 12, 2024000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesManufacturer1October 21, 2009000api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesManufacturer, Specification developer1May 4, 2010000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1July 23, 2002000api.fda.gov
Louis M. Gerson Co., Inc.Middleboro, MA, United StatesManufacturer1November 17, 2006000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesContract manufacturer, Manufacturer1October 6, 2010000api.fda.gov
Advanced Concept Innovations LLCLakeland, FL, United StatesManufacturer0000api.fda.gov
BNX Converting, LLCHouston, TX, United StatesManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer0000api.fda.gov
Healthplus, LLCAsheville, NC, United StatesManufacturer0000api.fda.gov
Laguna ScientificAliso Viejo, CA, United StatesSpecification developer0000api.fda.gov
LWS Health & SafetyWhite City, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Mid-America Safety CorpElk Grove Village, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Obbomed Group LLCPomona, CA, United StatesSpecification developer0000api.fda.gov
Ouachita Contract Manufacturing, LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Riskwise Supplies LLCLorton, VA, United StatesManufacturer0000api.fda.gov
Secure Personal Care Products, LLCSouth San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Splashblocker Distribution Company, LLCYardley, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.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.