Data / Medical devices / Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (DRY): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (product code DRY, Class 2, 21 CFR 870.4330). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on April 25, 2024, and lists 18 recall events (0 Class I). 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.
- Product code
- DRY
- Device class
- 2
- Regulation
- 870.4330
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| United Kingdom | 1 |
| Germany | 1 |
| Mexico | 1 |
| Italy | 1 |
Makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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 |
|---|---|---|---|---|---|---|---|---|
| Spectrum Medical Ltd | GLOUCESTER Gloucestershire, United Kingdom | Manufacturer | 6 | October 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| LivaNova Deutschland GmbH | MUNCHEN Bavaria, Germany | Manufacturer | 2 | April 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 2 | October 23, 2014 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 1 | October 23, 2014 | 0 | 0 | 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 |
| Sorin Group Italia S.R.L | MIRANDOLA Modena, Italy | Manufacturer | 1 | April 1, 2021 | 0 | 0 | 0 | api.fda.gov |
Updated April 25, 2024. 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.