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Data / Medical devices / Oxygenator, Cardiopulmonary Bypass

Oxygenator, Cardiopulmonary Bypass (DTZ): 15 FDA-registered makers in 7 countries

15 establishments in 7 countries are registered with the FDA to make Oxygenator, Cardiopulmonary Bypass (product code DTZ, Class 2, 21 CFR 870.4350). 15 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 255 510(k) clearances under this code, the latest on September 14, 2026, and lists 43 recall events (2 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
DTZ
Device class
2
Regulation
870.4350
Medical specialty
Cardiovascular
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States5
Italy3
Japan2
Germany2
Mexico1
United Kingdom1
China1

Makers of Oxygenator, Cardiopulmonary Bypass

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
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer19July 10, 2024080api.fda.gov
Sorin Group Italia S.R.LMIRANDOLA Modena, ItalyManufacturer18November 16, 2023000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer14June 12, 2024000api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer8March 13, 2013000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer8June 22, 2018030api.fda.gov
Terumo Corp.Shibuya-Ku, Tokyo, JapanExporter to the US, Manufacturer8March 13, 2013000api.fda.gov
Eurosets s.r.l.Medolla Modena, ItalyManufacturer7September 14, 2026000api.fda.gov
Spectrum Medical SRLMirandola Modena, ItalyManufacturer5March 12, 2026000api.fda.gov
MAQUET CARDIOPULMONARY GmbHHechingen Baden-Wurttemberg, GermanyManufacturer4May 7, 2015000api.fda.gov
Chalice Medical LtdWorksop Nottinghamshire, United KingdomManufacturer3November 1, 2023000api.fda.gov
Breethe, Inc.Halethorpe, MD, United StatesManufacturer1February 23, 2023000api.fda.gov
Lifemotion Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer1March 16, 2026000api.fda.gov
MAQUET CARDIOPULMONARY GmbHRastatt Baden-Wurttemberg, GermanySpecification developer1April 30, 2010000api.fda.gov
Novosci Corp.Conroe, TX, United StatesManufacturer, Repackager or relabeler1April 23, 1981000api.fda.gov
Thoratec Corp.Pleasanton, CA, United StatesManufacturer1December 1, 2022000api.fda.gov

Updated September 14, 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.