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Data / Medical devices / Oximeter, Tissue Saturation

Oximeter, Tissue Saturation (MUD): 47 FDA-registered makers in 16 countries

47 establishments in 16 countries are registered with the FDA to make Oximeter, Tissue Saturation (product code MUD, Class 2, 21 CFR 870.2700). 19 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 74 510(k) clearances under this code, the latest on May 22, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MUD
Device class
2
Regulation
870.2700
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States22
China6
Japan3
Mexico3
Canada2
Ireland1
Dominican Republic1
United Kingdom1
Sweden1
Singapore1
Finland1
Poland1
Netherlands1
India1
Germany1
Malaysia1

Makers of Oximeter, Tissue Saturation

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

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
Kent Imaging IncCalgary Alberta, CanadaManufacturer4April 2, 2024010api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer4August 4, 2014000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer3November 17, 2023010api.fda.gov
Covidien- Galway(County), IrelandManufacturer3December 5, 2021000api.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
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer1April 10, 2015000api.fda.gov
Hamamatsu Photonics K.K., Systems DivisionHAMAMATSU CITY Shizuoka, JapanComplaint file establishment, Manufacturer1July 31, 2015000api.fda.gov
HyperMed Technologies Corp.Grand Forks, ND, United StatesManufacturer, Specification developer1December 16, 2016000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer1May 6, 2022000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1May 6, 2022000api.fda.gov
Mimosa Diagnostics Inc.Toronto Ontario, CanadaComplaint file establishment, Manufacturer1November 1, 2019000api.fda.gov
Modulated Imaging, Inc.Costa Mesa, CA, United StatesComplaint file establishment, Manufacturer1July 19, 2018000api.fda.gov
Moor Instruments Ltd.AXMINSTER Devon, United KingdomManufacturer1October 10, 2012000api.fda.gov
Neko Health ABSolna, SwedenExporter to the US, Manufacturer1May 22, 2026000api.fda.gov
Advantech CorporationMilpitas, CA, United StatesContract manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
BENCHMARK ELECTRONICS San JorgeTlajomulco de Zuniga Jalisco, MexicoContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Celestica Electronics (S) Pte Ltd.Singapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanContract manufacturer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.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
Jiangyin Sinbon Electronics Co LtdJiangyin Jiangsu, ChinaContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Lode B.V.Groningen, NetherlandsManufacturer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Measurement Specialties ChengduChengdu Sichuan, ChinaContract manufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer0000api.fda.gov
Osi Systems Pvt Ltd(optoelectronics Division)HYDERABAD Telangana, IndiaContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov

Updated May 22, 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.