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
| Country | Makers |
|---|---|
| United States | 14 |
| United Kingdom | 3 |
| China | 3 |
| Norway | 2 |
| Germany | 2 |
| Japan | 1 |
| Sweden | 1 |
| Taiwan | 1 |
| Switzerland | 1 |
| Canada | 1 |
| Dominican Republic | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hadeco, Inc. | KAWASAKI Kanagawa, Japan | Manufacturer | 5 | January 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Perimed AB | JARFALLA Stockholm, Sweden | Complaint file establishment, Manufacturer | 3 | May 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 3 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 3 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Deltex Medical Limited | CHICHESTER West Sussex, United Kingdom | Manufacturer | 2 | October 10, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medistim Asa | HORTEN Vestfold, Norway | Manufacturer | 2 | December 27, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medistim Asa | Oslo, Norway | Specification developer | 2 | December 27, 2010 | 0 | 2 | 0 | api.fda.gov |
| Microlife Corp. | Taipei, Taiwan | Manufacturer | 2 | April 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Microlife Intellectual Property GMBH | Widnau Sankt Gallen, Switzerland | Specification developer | 2 | April 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Onbo Electronic (shenzhen) Co. Ltd. | SHENZHEN Guangdong, China | Manufacturer | 2 | April 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Transonic Systems, Inc. | Ithaca, NY, United States | Manufacturer | 2 | December 21, 2011 | 0 | 1 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 1 | March 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | March 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan City Guangdong, China | Manufacturer | 1 | March 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Flosonics Medical (r/A 1929803 Ontario Corp.) | Toronto Ontario, Canada | Exporter to the US, Manufacturer, Reprocessor | 1 | March 24, 2020 | 0 | 1 | 0 | api.fda.gov |
| Hemedex Incorporated | North Waltham, MA, United States | Manufacturer | 1 | May 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| Huntleigh Healthcare Ltd. | Cardiff, South Glamorgan, United Kingdom | Complaint file establishment, Manufacturer | 1 | September 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| MAQUET CARDIOPULMONARY GmbH | Rastatt Baden-Wurttemberg, Germany | Specification developer | 1 | August 19, 1999 | 0 | 0 | 0 | api.fda.gov |
| Moor Instruments Ltd. | AXMINSTER Devon, United Kingdom | Manufacturer | 1 | November 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, S.A. | Santo Domingo Este, Dominican Republic | Contract manufacturer, Manufacturer | 1 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Manufacturer, Specification developer | 1 | October 28, 2008 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 1 | May 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Vascular Technology Incorporated | Nashua, NH, United States | Manufacturer | 1 | October 28, 2008 | 0 | 2 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Specification developer | 1 | January 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Ellettsville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medikomp GMBH | Rastatt Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parks Medical Electronics, Inc. | Aloha, OR, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Plastics Group | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.