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Data / Medical devices / Oximeter, Tissue Saturation / United States

FDA-registered makers of Oximeter, Tissue Saturation in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Oximeter, Tissue Saturation (product code MUD). 11 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Oximeter, Tissue Saturation
Product code
MUD
Country
United States

Makers of Oximeter, Tissue Saturation in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Vioptix, Inc.Newark, CA, United StatesManufacturer6June 26, 2025000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer4December 5, 2021010api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer4August 4, 2014000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer3November 17, 2023010api.fda.gov
Nonin Medical, Inc.Plymouth, MN, United StatesContract manufacturer, Manufacturer3May 2, 2019010api.fda.gov
Spectros Medical Devices IncHouston, TX, United StatesComplaint file establishment, Manufacturer3September 23, 2019000api.fda.gov
Qostronics IncSan Jose, CA, United StatesManufacturer2September 23, 2019000api.fda.gov
Biowound SolutionsLas Vegas, NV, United StatesManufacturer1April 2, 2024000api.fda.gov
HyperMed Technologies Corp.Grand Forks, ND, United StatesManufacturer, Specification developer1December 16, 2016000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1May 6, 2022000api.fda.gov
Modulated Imaging, Inc.Costa Mesa, CA, United StatesComplaint file establishment, Manufacturer1July 19, 2018000api.fda.gov
Advantech CorporationMilpitas, CA, United StatesContract manufacturer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.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
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.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.