Data / Medical devices / Accessory Equipment, Cardiopulmonary Bypass / United States
FDA-registered makers of Accessory Equipment, Cardiopulmonary Bypass in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Accessory Equipment, Cardiopulmonary Bypass (product code KRI). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Accessory Equipment, Cardiopulmonary Bypass
- Product code
- KRI
- Country
- United States
Makers of Accessory Equipment, Cardiopulmonary Bypass in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Repackager or relabeler | 2 | January 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Med Michigan Holdings LLC | Lake Odessa, MI, United States | Manufacturer, Specification developer | 1 | May 3, 2002 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 1 | January 30, 1981 | 0 | 0 | 0 | api.fda.gov |
| CardioQuip | College Station, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kluge Design Inc. | Rogers, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MC3, Inc. | Dexter, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Santa Barbara Imaging Systems | Goleta, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.