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Data / Medical devices / Ventilator, Non-Continuous (Respirator) / United States

FDA-registered makers of Ventilator, Non-Continuous (Respirator) in the United States: 38 establishments

38 establishments in the United States are registered with the FDA to make Ventilator, Non-Continuous (Respirator) (product code BZD). 24 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Ventilator, Non-Continuous (Respirator)
Product code
BZD
Country
United States

Makers of Ventilator, Non-Continuous (Respirator) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Resmed CorpSan Diego, CA, United StatesComplaint file establishment, Manufacturer52June 4, 2026020api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer35September 25, 2026064api.fda.gov
3B Medical IncDublin, OH, United StatesComplaint file establishment, Manufacturer, Specification developer13March 25, 2022010api.fda.gov
Respironics, Inc.Mount Pleasant, PA, United StatesManufacturer, Repackager or relabeler10July 12, 2021000api.fda.gov
Sleepnet CorporationHampton, NH, United StatesManufacturer, Manufacturer for export9January 15, 2026011api.fda.gov
Salter LabsEl Paso, TX, United StatesComplaint file establishment, Specification developer7August 5, 2015000api.fda.gov
3B Medical IncW Jefferson, OH, United StatesManufacturer6March 25, 2022000api.fda.gov
CircadianceExport, PA, United StatesSpecification developer6March 15, 2017000api.fda.gov
Respironics, Inc.New Kensington, PA, United StatesManufacturer5July 10, 2020000api.fda.gov
Somnetics International, IncFridley, MN, United StatesManufacturer, Specification developer4April 17, 2026000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer4February 23, 2007000api.fda.gov
Breas Medical, Inc.N Billerica, MA, United StatesComplaint file establishment, Manufacturer2October 17, 2014000api.fda.gov
Genadyne Biotechnologies, Inc.Bohemia, NY, United StatesSpecification developer2December 31, 2024000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesManufacturer2December 1, 2003000api.fda.gov
Remsleep Holdings IncBlackshear, GA, United StatesSpecification developer2January 7, 2026000api.fda.gov
Airway Management Inc.Farmers Branch, TX, United StatesComplaint file establishment, Manufacturer1November 1, 2012000api.fda.gov
Bleep, LLCChapel Hill, NC, United StatesManufacturer1March 30, 2018000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1June 24, 1991011api.fda.gov
CovidienCarlsbad, CA, United StatesSpecification developer1September 6, 2000000api.fda.gov
Genadyne Biotechnologies, Inc.Hicksville, NY, United StatesSpecification developer1December 31, 2024000api.fda.gov
Hans Rudolph, Inc.Shawnee, KS, United StatesManufacturer1June 3, 2003000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1April 21, 1987000api.fda.gov
Sleepres, IncFremont, CA, United StatesSpecification developer1December 15, 2025000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer1August 3, 2005000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Exceleron Medical, LLCSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Gilero, IncPittsboro, NC, United StatesContract manufacturer0000api.fda.gov
ResMed CorpLithia Spgs, GA, United StatesContract manufacturer0000api.fda.gov
ResMed Motor Technologies IncCalabasas, CA, United StatesContract manufacturer0000api.fda.gov
ResMed West Coast WarehouseMoreno Valley, CA, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Superior Felt & Filtration, LLCMcHenry, IL, United StatesContract manufacturer0000api.fda.gov
Springboard ManufacturingRancho Cordova, CA, United StatesContract manufacturer0000api.fda.gov
Wise Plastics TechnologiesWest Chicago, IL, 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.