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Data / Medical devices / Flowmeter, Blood, Cardiovascular

Flowmeter, Blood, Cardiovascular (DPW): 30 FDA-registered makers in 11 countries

30 establishments in 11 countries are registered with the FDA to make Flowmeter, Blood, Cardiovascular (product code DPW, Class 2, 21 CFR 870.2100). 24 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 138 510(k) clearances under this code, the latest on July 8, 2026, and lists 15 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DPW
Device class
2
Regulation
870.2100
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States14
United Kingdom3
China3
Norway2
Germany2
Japan1
Sweden1
Taiwan1
Switzerland1
Canada1
Dominican Republic1

Makers of Flowmeter, Blood, Cardiovascular

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
Hadeco, Inc.KAWASAKI Kanagawa, JapanManufacturer5January 5, 2021000api.fda.gov
Perimed ABJARFALLA Stockholm, SwedenComplaint file establishment, Manufacturer3May 5, 2016000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer3November 20, 2025000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer3November 20, 2025000api.fda.gov
Deltex Medical LimitedCHICHESTER West Sussex, United KingdomManufacturer2October 10, 2013000api.fda.gov
Medistim AsaHORTEN Vestfold, NorwayManufacturer2December 27, 2010000api.fda.gov
Medistim AsaOslo, NorwaySpecification developer2December 27, 2010020api.fda.gov
Microlife Corp.Taipei, TaiwanManufacturer2April 30, 1998000api.fda.gov
Microlife Intellectual Property GMBHWidnau Sankt Gallen, SwitzerlandSpecification developer2April 30, 1998000api.fda.gov
Onbo Electronic (shenzhen) Co. Ltd.SHENZHEN Guangdong, ChinaManufacturer2April 30, 1998000api.fda.gov
Transonic Systems, Inc.Ithaca, NY, United StatesManufacturer2December 21, 2011010api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer, Specification developer1March 16, 2011000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1March 16, 2011000api.fda.gov
Dongguan Mars Medical Products Co., Ltd.Dongguan City Guangdong, ChinaManufacturer1March 13, 1998000api.fda.gov
Flosonics Medical (r/A 1929803 Ontario Corp.)Toronto Ontario, CanadaExporter to the US, Manufacturer, Reprocessor1March 24, 2020010api.fda.gov
Hemedex IncorporatedNorth Waltham, MA, United StatesManufacturer1May 8, 2002000api.fda.gov
Huntleigh Healthcare Ltd.Cardiff, South Glamorgan, United KingdomComplaint file establishment, Manufacturer1September 6, 2019000api.fda.gov
MAQUET CARDIOPULMONARY GmbHRastatt Baden-Wurttemberg, GermanySpecification developer1August 19, 1999000api.fda.gov
Moor Instruments Ltd.AXMINSTER Devon, United KingdomManufacturer1November 18, 2010000api.fda.gov
Remington Medical, S.A.Santo Domingo Este, Dominican RepublicContract manufacturer, Manufacturer1November 20, 2025000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesManufacturer, Specification developer1October 28, 2008000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer1May 14, 2003000api.fda.gov
Vascular Technology IncorporatedNashua, NH, United StatesManufacturer1October 28, 2008020api.fda.gov
ev3, Inc.Plymouth, MN, United StatesSpecification developer1January 10, 2020000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Medikomp GMBHRastatt Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Parks Medical Electronics, Inc.Aloha, OR, United StatesManufacturer0020api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
Spectrum Plastics GroupSaint Louis Park, MN, United StatesContract manufacturer0000api.fda.gov

Updated July 8, 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.