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Data / Medical devices / Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass / United States

FDA-registered makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass in the United States: 36 establishments

36 establishments in the United States are registered with the FDA to make Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL). 22 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 2, 2026.

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Device
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Product code
DTL
Country
United States

Makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer6August 15, 1990010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler4December 17, 1996000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer4June 26, 1990000api.fda.gov
Novosci Corp.Conroe, TX, United StatesManufacturer, Repackager or relabeler, Specification developer4June 30, 1980010api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer3March 5, 2008010api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Specification developer2June 9, 1999020api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer2June 9, 1999000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler2July 5, 1994000api.fda.gov
Allwell Medical CorporationRaleigh, NC, United StatesManufacturer, Repackager or relabeler, Specification developer2January 22, 1993000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Manufacturer, Specification developer2October 18, 1984000api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer2January 12, 2012000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1June 21, 1995000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer1January 23, 1979000api.fda.gov
Galt Medical Corp.Garland, TX, United StatesContract manufacturer, Manufacturer1December 2, 2015000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1September 11, 1991000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer1December 16, 1983030api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1April 3, 2012042api.fda.gov
Medtronic VascularDanvers, MA, United StatesSpecification developer1February 3, 1995000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer1January 11, 2006010api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler1April 28, 2010030api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1July 17, 1986000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesSpecification developer1September 7, 2012032api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Excel Medical Products, Inc.Wixom, MI, United StatesManufacturer0000api.fda.gov
Insightra Medical, Inc.Clarksville, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Nexus Medical, LLCLenexa, KS, United StatesManufacturer0000api.fda.gov
Nventric, Inc.Arcadia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Trelleborg Sealing Solutions US, IncDelano, MN, United StatesContract manufacturer0000api.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.