Data / Medical devices / Cerebral Oximeter

Cerebral Oximeter (QEM): 18 FDA-registered makers in 9 countries

Name: FDA-registered makers of Cerebral Oximeter
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 9 countries are registered with the FDA to make Cerebral Oximeter (product code QEM, Class 2, 21 CFR 870.2700). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on December 26, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: QEM
Device class: 2
Regulation: 870.2700
Medical specialty: Cardiovascular

Makers by country

Country	Makers
United States	9
China	2
Canada	1
Dominican Republic	1
Singapore	1
Ireland	1
Finland	1
Mexico	1
Malaysia	1

Makers of Cerebral Oximeter

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	Source
Mespere Lifesciences Inc.	Waterloo Ontario, Canada	Manufacturer	1	December 26, 2018	api.fda.gov
Advantech Corporation	Milpitas, CA, United States	Contract manufacturer	0		api.fda.gov
Avnet, Inc. (Avnet Logistics)	Chandler, AZ, United States	Contract manufacturer	0		api.fda.gov
Becton, Dickinson And Company	Irvine, CA, United States	Specification developer	0		api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0		api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG	HAINA San Cristobal, Dominican Republic	Manufacturer	0		api.fda.gov
Celestica Electronics (S) Pte Ltd.	Singapore Central Singapore, Singapore	Contract manufacturer	0		api.fda.gov
Covidien	Lafayette, CO, United States	Specification developer	0		api.fda.gov
Covidien	- Galway(County), Ireland	Manufacturer	0		api.fda.gov
Ge Healthcare Finland OY	HELSINKI Uusimaa, Finland	Manufacturer	0		api.fda.gov
Ge Medical Systems (china) Co., Ltd.	WUXI Jiangsu, China	Specification developer	0		api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, Mexico	Manufacturer	0		api.fda.gov
GE Medical Systems Information Technologies, Inc.	Waukesha, WI, United States	Specification developer	0		api.fda.gov
GE Medical Systems Information Technologies, Inc.	Wauwatosa, WI, United States	Specification developer	0		api.fda.gov
Jiangyin Sinbon Electronics Co Ltd	Jiangyin Jiangsu, China	Contract manufacturer	0		api.fda.gov
Plexus Corp.	Buffalo Grove, IL, United States	Contract manufacturer	0		api.fda.gov
Repair Operations Center	Oak Creek, WI, United States	Remanufacturer	0		api.fda.gov
Supercomal Medical Products, Sdn Bhd	SUNGAI PETANI Kedah, Malaysia	Contract manufacturer	0		api.fda.gov

Updated December 26, 2018. 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.