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Data / Medical devices / Catheter, Oximeter, Fiber-Optic

Catheter, Oximeter, Fiber-Optic (DQE): 15 FDA-registered makers in 7 countries

15 establishments in 7 countries are registered with the FDA to make Catheter, Oximeter, Fiber-Optic (product code DQE, Class 2, 21 CFR 870.1230). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on February 20, 2018, and lists 3 recall events (0 Class I). 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 every maker of this deviceMakers in the United StatesWatch this device
Product code
DQE
Device class
2
Regulation
870.1230
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States7
Mexico3
Finland1
China1
Dominican Republic1
Malaysia1
Taiwan1

Makers of Catheter, Oximeter, Fiber-Optic

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
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer8February 20, 2018000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer8February 20, 2018000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer, Specification developer5July 2, 2014000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesSpecification developer2July 2, 2014010api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoManufacturer, Repackager or relabeler1July 2, 2014000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1December 29, 1992000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandContract manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
BENCHMARK ELECTRONICS San JorgeTlajomulco de Zuniga Jalisco, MexicoContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Maquilas Teta Kawi S.A. De C.V.NOGALES KM2 EMPALME Sonora, MexicoContract manufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov

Updated February 20, 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.