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Data / Medical devices / Mask, Oxygen / United States

FDA-registered makers of Mask, Oxygen in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Mask, Oxygen (product code BYG). 3 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Mask, Oxygen
Product code
BYG
Country
United States

Makers of Mask, Oxygen in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienLafayette, CO, United StatesSpecification developer1March 14, 1989000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer1April 19, 1994000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer1July 19, 1991000api.fda.gov
Aqp One, Inc.Garden Grove, CA, United StatesSpecification developer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer, Specification developer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
CircadianceExport, PA, United StatesSpecification developer0000api.fda.gov
Doner Industries, Inc.Rogers, AR, United StatesSpecification developer0000api.fda.gov
DynastheticsSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Hans Rudolph, Inc.Shawnee, KS, United StatesManufacturer0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer0000api.fda.gov
Life CorporationOrlando, FL, United StatesManufacturer0000api.fda.gov
Mada Medical Products, Inc.Carlstadt, NJ, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MDL Solutions IncorporatedHamel, MN, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
Oricare Inc.Quakertown, PA, United StatesSpecification developer0000api.fda.gov
Pari Respiratory Equipment, Inc.Midlothian, VA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Trelleborg Sealing Solutions US, IncDelano, MN, United StatesContract manufacturer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, 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.