Data / Medical devices / Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass / United States
FDA-registered makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass in the United States: 41 establishments
41 establishments in the United States are registered with the FDA to make Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF). 22 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Product code
- DWF
- Country
- United States
Makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 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 | 59 | January 20, 2026 | 0 | 21 | 2 | api.fda.gov |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 41 | January 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Enablecv, LLC | Midvale, UT, United States | Specification developer | 30 | February 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Med Michigan Holdings LLC | Lake Odessa, MI, United States | Manufacturer | 9 | August 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Manufacturer for export, Specification developer | 6 | September 7, 2000 | 0 | 12 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 4 | October 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 4 | October 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | June 30, 1980 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 3 | October 18, 1984 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | November 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| MC3, Inc. | Dexter, MI, United States | Manufacturer | 2 | February 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 2 | September 18, 2000 | 0 | 1 | 0 | api.fda.gov |
| Cardiogard Usa, Inc | Tyngsboro, MA, United States | Specification developer | 1 | May 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | September 27, 1993 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 1 | January 14, 2010 | 0 | 19 | 1 | api.fda.gov |
| Global Blood Resources, LLC | Windsor, CT, United States | Specification developer | 1 | June 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| KDL Medical, Inc. | Richardson, TX, United States | Complaint file establishment, Manufacturer | 1 | August 22, 1997 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 1 | August 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 1 | August 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | July 19, 2011 | 0 | 0 | 0 | api.fda.gov |
| Vitalcor, Inc. | Westmont, IL, United States | Manufacturer, Specification developer | 1 | April 18, 2003 | 0 | 0 | 0 | api.fda.gov |
| voss medical products | San Antonio, TX, United States | Manufacturer | 1 | May 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| Anodyne Surgical | O Fallon, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breethe, Inc. | Halethorpe, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesee Biomedical, Inc. | Denver, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nordson MEDICAL (CA), LLC | Huntingtn Bch, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pemco, Inc. | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRO-TECH Design & Mfg, Inc. | Arlington, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Putnam Medical Corp. | Dayville, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rose Medical | Grand Rapids, MI, 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 | |
| Specialty Manufacturing, Inc. | Saginaw, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, Inc. | Grand Rapids, MI, United States | Contract manufacturer | 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.