Data / Medical devices / Controller, Temperature, Cardiopulmonary Bypass / United States
FDA-registered makers of Controller, Temperature, Cardiopulmonary Bypass in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Controller, Temperature, Cardiopulmonary Bypass (product code DWC). 4 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Controller, Temperature, Cardiopulmonary Bypass
- Product code
- DWC
- Country
- United States
Makers of Controller, Temperature, Cardiopulmonary Bypass in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Complaint file establishment, Manufacturer | 2 | November 3, 1988 | 0 | 7 | 0 | api.fda.gov |
| CardioQuip | College Station, TX, United States | Manufacturer | 1 | November 19, 2010 | 0 | 4 | 0 | api.fda.gov |
| Genesee Biomedical, Inc. | Denver, CO, United States | Contract manufacturer, Manufacturer, Specification developer | 1 | January 29, 1988 | 0 | 0 | 0 | api.fda.gov |
| Gentherm Medical, LLC | Cincinnati, OH, United States | Manufacturer, Manufacturer for export | 1 | December 18, 2012 | 0 | 5 | 0 | api.fda.gov |
| Quest Medical, Inc. | Allen, TX, United States | 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.