Data / Medical devices / Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass / United States
FDA-registered makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (product code DRY). 5 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
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Product code
- DRY
- Country
- United States
Makers of Monitor, Blood-Gas, On-Line, 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 | 4 | April 25, 2024 | 0 | 15 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | November 2, 2018 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 2 | October 23, 2014 | 0 | 1 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 1 | July 31, 1990 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Specification developer | 1 | July 31, 1990 | 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.