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Data / Medical devices / Spirometer, Diagnostic / United States

FDA-registered makers of Spirometer, Diagnostic in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Spirometer, Diagnostic (product code BZG). 14 have 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
Spirometer, Diagnostic
Product code
BZG
Country
United States

Makers of Spirometer, Diagnostic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Sdi Diagnostics, Inc.South Easton, MA, United StatesManufacturer, Specification developer4January 12, 2016000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer3October 14, 1994000api.fda.gov
Monitored Therapeutics, Inc.Dublin, OH, United StatesComplaint file establishment, Specification developer2December 4, 2020000api.fda.gov
PULMONX, Corp.Redwood City, CA, United StatesComplaint file establishment, Manufacturer2July 13, 2018000api.fda.gov
Strados Labs Inc.Marietta, GA, United StatesSpecification developer2January 18, 2024000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer, Specification developer2September 10, 2019000api.fda.gov
CovidienCarlsbad, CA, United StatesSpecification developer1September 27, 2002000api.fda.gov
Global Life Sciences Solutions USA LLCMarlborough, MA, United StatesComplaint file establishment, Specification developer1November 7, 1985000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesSpecification developer1March 14, 2002000api.fda.gov
Polytechnic Resources, Inc.Seaford, DE, United StatesManufacturer1August 29, 2005000api.fda.gov
RemetricHealth Inc.Allentown, PA, United StatesSpecification developer1November 9, 2011000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer1October 6, 1986000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1August 10, 1979000api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesSpecification developer1April 19, 2012000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Diagnostic Group LLCEden Prairie, MN, United StatesContract manufacturer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Pulmone Usa IncCarrollton, TX, United StatesSpecification developer0000api.fda.gov
Sanbor MedicalAllentown, PA, 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.