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Data / Medical devices / Attachment, Breathing, Positive End Expiratory Pressure / United States

FDA-registered makers of Attachment, Breathing, Positive End Expiratory Pressure in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Attachment, Breathing, Positive End Expiratory Pressure (product code BYE). 12 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Attachment, Breathing, Positive End Expiratory Pressure
Product code
BYE
Country
United States

Makers of Attachment, Breathing, Positive End Expiratory Pressure in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer8September 12, 2011000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer3March 9, 1999000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer3September 12, 2011010api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesManufacturer, Repackager or relabeler, Specification developer2May 9, 2008000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer2August 20, 2009000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2July 14, 1998000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesSpecification developer1August 30, 1988000api.fda.gov
B & B Medical Technologies, Inc.Carlsbad, CA, United StatesComplaint file establishment, Specification developer1March 28, 2014000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer1August 22, 1991000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer1March 19, 1997000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer1January 21, 2003000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer1January 21, 2003000api.fda.gov
Airon CorporationMelbourne, FL, United StatesManufacturer0000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer0000api.fda.gov
MDL Solutions IncorporatedHamel, MN, 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.