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
| Country | Makers |
|---|---|
| United States | 22 |
| China | 6 |
| Japan | 3 |
| Mexico | 3 |
| Canada | 2 |
| Ireland | 1 |
| Dominican Republic | 1 |
| United Kingdom | 1 |
| Sweden | 1 |
| Singapore | 1 |
| Finland | 1 |
| Poland | 1 |
| Netherlands | 1 |
| India | 1 |
| Germany | 1 |
| Malaysia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vioptix, Inc. | Newark, CA, United States | Manufacturer | 6 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 4 | December 5, 2021 | 0 | 1 | 0 | api.fda.gov |
| Kent Imaging Inc | Calgary Alberta, Canada | Manufacturer | 4 | April 2, 2024 | 0 | 1 | 0 | api.fda.gov |
| Sotera Wireless | Carlsbad, CA, United States | Manufacturer | 4 | August 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 3 | November 17, 2023 | 0 | 1 | 0 | api.fda.gov |
| Covidien | - Galway(County), Ireland | Manufacturer | 3 | December 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nonin Medical, Inc. | Plymouth, MN, United States | Contract manufacturer, Manufacturer | 3 | May 2, 2019 | 0 | 1 | 0 | api.fda.gov |
| Spectros Medical Devices Inc | Houston, TX, United States | Complaint file establishment, Manufacturer | 3 | September 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Qostronics Inc | San Jose, CA, United States | Manufacturer | 2 | September 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Biowound Solutions | Las Vegas, NV, United States | Manufacturer | 1 | April 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 1 | April 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Hamamatsu Photonics K.K., Systems Division | HAMAMATSU CITY Shizuoka, Japan | Complaint file establishment, Manufacturer | 1 | July 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| HyperMed Technologies Corp. | Grand Forks, ND, United States | Manufacturer, Specification developer | 1 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mimosa Diagnostics Inc. | Toronto Ontario, Canada | Complaint file establishment, Manufacturer | 1 | November 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Modulated Imaging, Inc. | Costa Mesa, CA, United States | Complaint file establishment, Manufacturer | 1 | July 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Moor Instruments Ltd. | AXMINSTER Devon, United Kingdom | Manufacturer | 1 | October 10, 2012 | 0 | 0 | 0 | api.fda.gov |
| Neko Health AB | Solna, Sweden | Exporter to the US, Manufacturer | 1 | May 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Advantech Corporation | Milpitas, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avnet, Inc. (Avnet Logistics) | Chandler, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BENCHMARK ELECTRONICS San Jorge | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Celestica Electronics (S) Pte Ltd. | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lode B.V. | Groningen, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Measurement Specialties Chengdu | Chengdu Sichuan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osi Systems Pvt Ltd(optoelectronics Division) | HYDERABAD Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supercomal Medical Products, Sdn Bhd | SUNGAI PETANI Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.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.