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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer59January 20, 20260212api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer41January 20, 2026000api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer30February 5, 2024000api.fda.gov
Med Michigan Holdings LLCLake Odessa, MI, United StatesManufacturer9August 10, 2017000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesContract manufacturer, Contract sterilizer, Manufacturer, Manufacturer for export, Specification developer6September 7, 20000120api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer4October 24, 2025000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer4October 24, 2025000api.fda.gov
Novosci Corp.Conroe, TX, United StatesManufacturer, Repackager or relabeler, Specification developer4June 30, 1980000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer3October 18, 1984000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer3November 26, 2002000api.fda.gov
MC3, Inc.Dexter, MI, United StatesManufacturer2February 27, 2014000api.fda.gov
Quest Medical, Inc.Allen, TX, United StatesManufacturer2September 18, 2000010api.fda.gov
Cardiogard Usa, IncTyngsboro, MA, United StatesSpecification developer1May 17, 2019000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1September 27, 1993000api.fda.gov
Edwards Lifesciences LLCDraper, UT, United StatesManufacturer1January 14, 20100191api.fda.gov
Global Blood Resources, LLCWindsor, CT, United StatesSpecification developer1June 26, 2003000api.fda.gov
KDL Medical, Inc.Richardson, TX, United StatesComplaint file establishment, Manufacturer1August 22, 1997000api.fda.gov
Lemaitre Vascular, Inc.Burlington, MA, United StatesManufacturer1August 27, 2003000api.fda.gov
LeMaitre Vascular Inc.Billerica, MA, United StatesManufacturer1August 27, 2003000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1July 19, 2011000api.fda.gov
Vitalcor, Inc.Westmont, IL, United StatesManufacturer, Specification developer1April 18, 2003000api.fda.gov
voss medical productsSan Antonio, TX, United StatesManufacturer1May 17, 1990000api.fda.gov
Anodyne SurgicalO Fallon, MO, United StatesContract manufacturer0000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Breethe, Inc.Halethorpe, MD, United StatesManufacturer0000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesContract manufacturer0000api.fda.gov
Integra NeurosciencesAnasco, PR, United StatesManufacturer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Nordson MEDICAL (CA), LLCHuntingtn Bch, CA, United StatesContract manufacturer0000api.fda.gov
Pemco, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Putnam Medical Corp.Dayville, CT, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Rose MedicalGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Sterilization Services Of VirginiaRichmond, VA, United StatesContract manufacturer0000api.fda.gov
Specialty Manufacturing, Inc.Saginaw, MI, United StatesContract manufacturer0000api.fda.gov
Thoratec Corp.Pleasanton, CA, United StatesManufacturer0000api.fda.gov
Viant Medical, Inc.Grand Rapids, MI, United StatesContract manufacturer0000api.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.