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Data / Medical devices / Mouthpiece, Breathing / United States

FDA-registered makers of Mouthpiece, Breathing in the United States: 26 establishments

26 establishments in the United States are registered with the FDA to make Mouthpiece, Breathing (product code BYP). 1 has 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
Mouthpiece, Breathing
Product code
BYP
Country
United States

Makers of Mouthpiece, Breathing in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medi Nuclear Corp., Inc.Baldwin Park, CA, United StatesManufacturer1January 15, 1987000api.fda.gov
A-M SystemsSequim, WA, United StatesManufacturer0000api.fda.gov
Airway Management Inc.Farmers Branch, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Alliance Tech Medical, Inc.Granbury, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
D R Burton Healthcare, LLCFarmville, NC, United StatesSpecification developer0000api.fda.gov
ForwardonticsSan Mateo, CA, United StatesComplaint file establishment, Specification developer0000api.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
LG Medical Design, LLCSalt Lake City, UT, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Monitored Therapeutics, Inc.Dublin, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Polytechnic Resources, Inc.Seaford, DE, United StatesManufacturer0000api.fda.gov
Precision Fluidics Division Parker Hannifin Corp.Hatfield, PA, United StatesManufacturer0000api.fda.gov
Respiratory Delivery Systems, Inc.Chelmsford, MA, United StatesManufacturer0000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sdi Diagnostics, Inc.South Easton, MA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Sontek Medical, LLCRochester, NH, United StatesSpecification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer0000api.fda.gov
TechNH, INC.Merrimack, NH, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
VectraCor, Inc.Maple Grove, MN, United StatesSpecification developer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Contract sterilizer, 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.