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Data / Medical devices / Oximeter / United States

FDA-registered makers of Oximeter in the United States: 90 establishments

90 establishments in the United States are registered with the FDA to make Oximeter (product code DQA). 41 have a 510(k) clearance or PMA approval on file and 10 have 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.

Get makers of this device in the United StatesWatch these makers
Device
Oximeter
Product code
DQA
Country
United States

Makers of Oximeter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer31December 15, 2023020api.fda.gov
Nonin Medical, Inc.Plymouth, MN, United StatesContract manufacturer, Manufacturer, Specification developer27June 29, 2020030api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer15May 6, 2022030api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer13May 1, 2009000api.fda.gov
Osi Optoelectronics (medical Division)Hawthorne, CA, United StatesContract manufacturer, Specification developer6June 15, 2006000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer5May 20, 2024000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler5July 9, 2010000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer4May 20, 2022000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer2November 26, 2008000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler2December 31, 2019000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer2July 27, 2017000api.fda.gov
Philips North America LLCAndover, MA, United StatesManufacturer, Specification developer2July 27, 2017050api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer2October 19, 1990010api.fda.gov
Waters Medical Systems, LLCRochester, MN, United StatesManufacturer2October 23, 1992000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer1September 14, 2011000api.fda.gov
Alc Enterprises IncBrooklyn, NY, United StatesSpecification developer1August 28, 2014000api.fda.gov
AnriwellRiverside, CA, United StatesRepackager or relabeler, Specification developer1July 1, 2024000api.fda.gov
Accriva Diagnostics, Inc.San Diego, CA, United StatesManufacturer1November 4, 1992010api.fda.gov
Allied Medical LLCEarth City, MO, United StatesSpecification developer1March 25, 1998000api.fda.gov
Buffalo OfficeBuffalo, NY, United StatesManufacturer1August 28, 2024000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer1March 5, 2007000api.fda.gov
Conmed CorporationUtica, NY, United StatesManufacturer1August 31, 2004000api.fda.gov
CareFusion 303, INCSan Diego, CA, United StatesComplaint file establishment, Specification developer1June 8, 2001000api.fda.gov
CovidienPlainfield, IN, United StatesManufacturer1March 7, 2002000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer1July 1, 2024000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler1December 31, 2019000api.fda.gov
Hinlab Inc.Lewes, DE, United StatesComplaint file establishment, Specification developer1December 21, 2023000api.fda.gov
Metene LimitedCity of Industry, CA, United StatesSpecification developer1September 13, 2019000api.fda.gov
Movano Inc. Dba Movano HealthPleasanton, CA, United StatesSpecification developer1November 29, 2024000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor1March 22, 2019000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer1September 12, 2008000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesSpecification developer1August 13, 2007000api.fda.gov
Owlet Baby CareLehi, UT, United StatesComplaint file establishment, Specification developer1June 16, 2023000api.fda.gov
Oxiwear IncArlington, VA, United StatesComplaint file establishment, Manufacturer1August 28, 2024000api.fda.gov
Prevounce Health, IncIndianapolis, IN, United StatesComplaint file establishment, Specification developer1August 28, 2014000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer1May 28, 2024000api.fda.gov
Spiracle TechnologyLos Alamitos, CA, United StatesSpecification developer1August 13, 2007000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer1March 8, 2022000api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesReprocessor1March 8, 2022000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer1June 15, 2006000api.fda.gov
usocmedicalIrvine, CA, United StatesSpecification developer1February 6, 2015000api.fda.gov
Aidar Health, IncColumbia, MD, United StatesManufacturer, Specification developer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Axcesor LLCMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
ActiGraph L.L.C.Pensacola, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Breas Medical, Inc.N Billerica, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
CircadianceExport, PA, United StatesSpecification developer0000api.fda.gov
CMI Health, Inc.Alpharetta, GA, United StatesSpecification developer0000api.fda.gov
Criticare Technologies, Inc.Warwick, RI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0010api.fda.gov
Ever Ppe IncSealy, TX, United StatesContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Flash GlobalLockbourne, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Happy HealthAustin, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
LifeSignals, Inc.Milpitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medipines CorporationYorba Linda, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Medwand Solutions, IncRsm, CA, United StatesSpecification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0010api.fda.gov
Medtronic Care Management ServicesLafayette, CO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Murata Vios, Inc.Woodbury, MN, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Neurotronics, LLCAlachua, FL, United StatesManufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Prosomnus Sleep TechnologiesPleasanton, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
REMwareTampa, FL, United StatesManufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0010api.fda.gov
Radiometer MinneapolisNew Brighton, MN, United StatesManufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Suntech Medical, Inc.Morrisville, NC, United StatesManufacturer0000api.fda.gov
TD SynnexGroveport, OH, United StatesContract manufacturer0000api.fda.gov
Wellvii IncPalm Beach Gardens, FL, United StatesSpecification developer0000api.fda.gov
Zoe Medical, Inc.Topsfield, MA, United StatesManufacturer0010api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
ZOLL Medical CorporationPawtucket, RI, United StatesContract manufacturer0000api.fda.gov
ZOLL Medical CorporationDeerfield, WI, 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.