Data / Medical devices / Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type / United States
FDA-registered makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (product code KFM). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. 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.
- Device
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Product code
- KFM
- Country
- United States
Makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 7 | August 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 2 | November 18, 2021 | 0 | 3 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer | 2 | July 13, 1990 | 0 | 5 | 0 | api.fda.gov |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 2 | October 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| Thoratec Corporation | San Ramon, CA, United States | Manufacturer | 1 | March 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| Breethe, Inc. | Halethorpe, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kluge Design Inc. | Rogers, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterilization Services Of Virginia | Richmond, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.