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Data / Medical devices / Oximeter, Ear

Oximeter, Ear (DPZ): 39 FDA-registered makers in 14 countries

39 establishments in 14 countries are registered with the FDA to make Oximeter, Ear (product code DPZ, Class 2, 21 CFR 870.2710). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on December 6, 2004, and lists 4 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
DPZ
Device class
2
Regulation
870.2710
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States14
China5
Mexico4
India3
Germany2
Switzerland2
Poland2
Ireland1
Finland1
Vietnam1
Malaysia1
Brazil1
Denmark1
Taiwan1

Makers of Oximeter, Ear

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
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer1October 17, 1994000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Boyd Corporation GmbHSyke Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Buffalo OfficeBuffalo, NY, United StatesManufacturer0000api.fda.gov
CovidienPlainfield, IN, United StatesManufacturer0000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer0000api.fda.gov
Covidien- Galway(County), IrelandManufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Repackager or relabeler, Specification developer0011api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.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
Given Imaging Vietnam Co., Ltd.Ho Chi Minh City, VietnamManufacturer0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHDPasir Gudang Johor, MalaysiaComplaint file establishment, Manufacturer0000api.fda.gov
Measurement Specialties ChengduChengdu Sichuan, ChinaContract manufacturer0000api.fda.gov
Murata Vios, Inc.Woodbury, MN, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Murata Vios, Private LimitedKodihalli, Bangalore Karnataka, IndiaManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Nonin Medical, Inc.Plymouth, MN, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Osi Optoelectronics (medical Division)Hawthorne, CA, United StatesContract manufacturer0000api.fda.gov
Osi Systems Pvt Ltd(optoelectronics Division)HYDERABAD Telangana, IndiaContract manufacturer0000api.fda.gov
Oxiwear IncArlington, VA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Radiometer Basel AGBASEL Basel-Stadt, SwitzerlandContract manufacturer0000api.fda.gov
Radiometer Medical ApsBROENSHOEJ Hovedstaden, DenmarkComplaint file establishment, Manufacturer0000api.fda.gov
Radiometer Solutions Sp. z o.o.Stargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Radiometer Sp. z o.oStargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Sentec AGTHERWIL Basel-Landschaft, SwitzerlandContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaSpecification developer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov

Updated December 6, 2004. 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.