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Data / Medical devices / Ventilator, Continuous, Facility Use / United States

FDA-registered makers of Ventilator, Continuous, Facility Use in the United States: 48 establishments

48 establishments in the United States are registered with the FDA to make Ventilator, Continuous, Facility Use (product code CBK). 32 have a 510(k) clearance or PMA approval on file and 12 have a recall event. FDA data exported November 2, 2026.

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Device
Ventilator, Continuous, Facility Use
Product code
CBK
Country
United States

Makers of Ventilator, Continuous, Facility Use in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienCarlsbad, CA, United StatesComplaint file establishment, Specification developer15November 20, 2020022api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer14December 30, 202403415api.fda.gov
Datex-Ohmeda, Inc.Madison, WI, United StatesManufacturer, Specification developer11November 4, 2021000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer7December 13, 2024031api.fda.gov
Respironics, Inc.Mount Pleasant, PA, United StatesManufacturer, Repackager or relabeler6July 18, 2019000api.fda.gov
Zoll Medical CorporationWilmington, MA, United StatesManufacturer, Repackager or relabeler6December 13, 2024000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer5May 4, 2020000api.fda.gov
Nihon Kohden Orangemed, LLCSanta Ana, CA, United StatesManufacturer4March 1, 2024010api.fda.gov
Resmed CorpSan Diego, CA, United StatesComplaint file establishment, Manufacturer4April 26, 2018010api.fda.gov
Airon CorporationMelbourne, FL, United StatesManufacturer3October 11, 2012000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer2June 14, 1988000api.fda.gov
Bio-Med Devices, Inc.Guilford, CT, United StatesManufacturer2July 20, 2018020api.fda.gov
Event Medical, Ltd.Lake Forest, CA, United StatesManufacturer2December 18, 2012021api.fda.gov
Sleepnet CorporationHampton, NH, United StatesManufacturer, Manufacturer for export2August 28, 2024000api.fda.gov
Breas Medical, Inc.N Billerica, MA, United StatesComplaint file establishment, Specification developer1December 19, 2025010api.fda.gov
Corvent Medical Inc.Fargo, ND, United StatesManufacturer1November 13, 2024000api.fda.gov
Hans Rudolph, Inc.Shawnee, KS, United StatesManufacturer1May 2, 2003000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1April 28, 1998000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer1September 17, 1999000api.fda.gov
International Biomedical, Ltd.Austin, TX, United StatesComplaint file establishment, Manufacturer1June 13, 1991000api.fda.gov
Lung Assist Ii IncBoulder, CO, United StatesSpecification developer1May 28, 1980000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer1August 28, 2025000api.fda.gov
Origin Medical Devices IncNewport Beach, CA, United StatesSpecification developer1July 20, 2023000api.fda.gov
Oricare Inc.Quakertown, PA, United StatesSpecification developer1June 6, 2013000api.fda.gov
Percussionaire Corp.Sandpoint, ID, United StatesManufacturer1May 3, 1991043api.fda.gov
Salter LabsEl Paso, TX, United StatesComplaint file establishment, Specification developer1August 17, 2006000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1August 12, 2011000api.fda.gov
Telesair, Inc.Irvine, CA, United StatesManufacturer1May 8, 2025000api.fda.gov
Ventec Life Systems, Inc.Woodinville, WA, United StatesManufacturer1April 7, 2017000api.fda.gov
Ventec Life Systems, Inc.Bothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1April 7, 2017053api.fda.gov
Ventis Medical IncPrinceton, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1August 13, 2024000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer1August 11, 2017000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer for export0000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer0000api.fda.gov
Hamilton Medical, Inc.Reno, NV, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
ResMed CorpLithia Spgs, GA, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Sechrist Industries, Inc.Anaheim, CA, United StatesManufacturer0010api.fda.gov
Sanmina CorporationCarrollton, TX, United StatesContract manufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
TD SynnexGroveport, OH, United StatesContract manufacturer0000api.fda.gov
Tecme CorporationNorcross, GA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
TreyMed, Inc.Sussex, WI, United StatesContract manufacturer0000api.fda.gov
ZOLL Medical CorporationPawtucket, RI, United StatesContract manufacturer0000api.fda.gov
ZOLL Medical CorporationDeerfield, WI, United StatesContract manufacturer0000api.fda.gov
ZOLL Palm SpringsPalm Springs, CA, United StatesManufacturer for export0030api.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.