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Data / Medical devices / Ventilator, Continuous, Non-Life-Supporting / United States

FDA-registered makers of Ventilator, Continuous, Non-Life-Supporting in the United States: 8 establishments

8 establishments in the United States are registered with the FDA to make Ventilator, Continuous, Non-Life-Supporting (product code MNS). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Ventilator, Continuous, Non-Life-Supporting
Product code
MNS
Country
United States

Makers of Ventilator, Continuous, Non-Life-Supporting in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Resmed CorpSan Diego, CA, United StatesComplaint file establishment, Manufacturer10April 8, 2026000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer6February 1, 2012096api.fda.gov
Respironics, Inc.Mount Pleasant, PA, United StatesManufacturer3February 1, 2012000api.fda.gov
Respironics, Inc.New Kensington, PA, United StatesManufacturer2January 22, 2010000api.fda.gov
SMD Manufacturing LLCSalt Lake City, UT, United StatesComplaint file establishment, Specification developer2July 13, 2023000api.fda.gov
3B Medical IncW Jefferson, OH, United StatesManufacturer1December 5, 2022000api.fda.gov
Salter LabsEl Paso, TX, United StatesComplaint file establishment, Specification developer1January 14, 2004000api.fda.gov
ResMed CorpLithia Spgs, GA, 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.