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Data / Medical devices / Set, Administration, Intravascular / United States

FDA-registered makers of Set, Administration, Intravascular in the United States: 117 establishments

117 establishments in the United States are registered with the FDA to make Set, Administration, Intravascular (product code FPA). 78 have a 510(k) clearance or PMA approval on file and 30 have a recall event. FDA data exported November 3, 2026.

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Device
Set, Administration, Intravascular
Product code
FPA
Country
United States

Makers of Set, Administration, Intravascular in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer29July 24, 2025030api.fda.gov
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer27January 6, 20170120api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer26March 14, 20250241api.fda.gov
CarefusionSan Diego, CA, United StatesSpecification developer23October 30, 2025030api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer22June 5, 20250121api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler17August 18, 2014000api.fda.gov
Multi-Med, Inc.Keene, NH, United StatesContract manufacturer, Manufacturer16July 6, 2012000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer13August 18, 2016040api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer13May 2, 2012010api.fda.gov
Nexus Medical, LLCLenexa, KS, United StatesContract manufacturer, Manufacturer, Specification developer12July 9, 2013000api.fda.gov
Vygon MFGDover, NH, United StatesContract manufacturer, Contract sterilizer, Manufacturer12May 2, 2012090api.fda.gov
Douglas Medical Products, IncMundelein, IL, United StatesComplaint file establishment, Specification developer11July 28, 2017000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer10October 17, 2012010api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer10December 17, 2010000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer10August 22, 2024041api.fda.gov
Quest Medical, Inc.Allen, TX, United StatesComplaint file establishment, Contract manufacturer, Manufacturer9December 18, 2024020api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer for export, Specification developer8August 10, 2016071api.fda.gov
Baxter Healthcare of Puerto Rico LLCAibonito, PR, United StatesManufacturer7October 8, 2013000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer6September 21, 1995010api.fda.gov
Codan Us Corp.Santa Ana, CA, United StatesContract manufacturer, Manufacturer5October 21, 2004020api.fda.gov
MPS Pharma & Medical, Inc.Brea, CA, United StatesManufacturer5November 10, 2010000api.fda.gov
NP MedicalClinton, MA, United StatesComplaint file establishment, Manufacturer, Specification developer5December 4, 2025000api.fda.gov
Emed Technologies CorporationEl Dorado Hills, CA, United StatesSpecification developer4May 15, 2014000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Repackager or relabeler3June 9, 20110192api.fda.gov
Primrose Medical, Inc.East Walpole, MA, United StatesManufacturer3September 8, 2003000api.fda.gov
410 Medical Inc.Durham, NC, United StatesComplaint file establishment, Specification developer2May 20, 2020000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer2March 29, 2002000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler2September 7, 2000000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler2June 21, 1996000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer2March 29, 2002010api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesContract sterilizer, Manufacturer, Specification developer2February 23, 2021010api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler2February 19, 2015000api.fda.gov
Bayer Medical Care Inc.Indianola, PA, United StatesComplaint file establishment, Manufacturer2June 5, 2009020api.fda.gov
Dragon Heart Medical, Inc.Elmhurst, IL, United StatesSpecification developer2November 18, 2010000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesSpecification developer2August 31, 2007000api.fda.gov
Innovative Health SciencesChester, NY, United StatesComplaint file establishment, Manufacturer, Specification developer2March 1, 2024000api.fda.gov
Koru Medical Systems, Inc.Mahwah, NJ, United StatesManufacturer, Manufacturer for export, Specification developer2May 6, 2013000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2January 8, 2014000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer2December 23, 2008020api.fda.gov
Molded Products Inc.Harlan, IA, United StatesManufacturer2August 16, 1993020api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesManufacturer, Repackager or relabeler2August 1, 2025000api.fda.gov
RyMed Technologies, LLCAustin, TX, United StatesSpecification developer2July 29, 2010020api.fda.gov
Us Infusion LLC. D/B/A Truecare Biomedix-UsaSouth Miami, FL, United StatesComplaint file establishment, Specification developer2June 8, 2012010api.fda.gov
Yukon Medical, LLCDurham, NC, United StatesComplaint file establishment, Manufacturer, Specification developer2June 2, 2017000api.fda.gov
Zyno Medical LLC.Natick, MA, United StatesManufacturer, Specification developer2January 23, 2014020api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler1May 1, 1990000api.fda.gov
Allergan Sales, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer1July 14, 1995000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1June 29, 1998000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer1July 10, 2006000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1January 26, 1996020api.fda.gov
Biomedix WaiChanhassen, MN, United StatesComplaint file establishment, Specification developer1August 29, 2014010api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesSpecification developer1August 26, 2020000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer1June 23, 2011010api.fda.gov
Custom Assemblies, Inc.Pine Level, NC, United StatesManufacturer1January 4, 2000000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1March 24, 1997000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer1August 20, 1981000api.fda.gov
Deka Research & Development Corp.Manchester, NH, United StatesSpecification developer1August 1, 2025000api.fda.gov
Directmed, Inc.Glen Cove, NY, United StatesComplaint file establishment, Specification developer1May 28, 2015000api.fda.gov
Ecomed Solutions, LLCLindenhurst, IL, United StatesComplaint file establishment, Specification developer1June 11, 2009000api.fda.gov
Epimed International, Inc.Johnstown, NY, United StatesManufacturer1July 12, 2002000api.fda.gov
Fresenius Kabi USA, LLCNorth Andover, MA, United StatesManufacturer, Specification developer1November 10, 2021022api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler1May 31, 2017000api.fda.gov
Genesisbps LLCMahwah, NJ, United StatesSpecification developer1February 13, 2009000api.fda.gov
Haolang Medical Usa CorporationClyde Hill, WA, United StatesSpecification developer1May 4, 2012000api.fda.gov
Intl. Medical IndustriesPompano Beach, FL, United StatesManufacturer1January 11, 2019000api.fda.gov
Mcguff Company, Inc.Santa Ana, CA, United StatesSpecification developer1August 14, 2021000api.fda.gov
Medela LLCMchenry, IL, United StatesManufacturer1October 6, 1989020api.fda.gov
Medsafety Solutions LLCCentennial, CO, United StatesComplaint file establishment, Specification developer1October 29, 2020000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesComplaint file establishment, Manufacturer1August 1, 2025000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer, Repackager or relabeler1May 30, 1985000api.fda.gov
Neochild, LLCOklahoma City, OK, United StatesSpecification developer1February 5, 2001000api.fda.gov
Norfolk Medical Products, Inc.Skokie, IL, United StatesManufacturer1February 10, 1987000api.fda.gov
Procedure Products, Inc.Vancouver, WA, United StatesManufacturer1May 21, 1981000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer1May 30, 1989000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1December 30, 2008000api.fda.gov
Tandem Diabetes Care, Inc.Irvine, CA, United StatesSpecification developer1August 6, 2025000api.fda.gov
Takeda Pharmaceuticals U.S.A., Inc.Lexington, MA, United StatesSpecification developer1June 29, 2012000api.fda.gov
Wall Medical, Inc.Buford, GA, United StatesSpecification developer1March 22, 1994000api.fda.gov
Baxter Healthcare CorporationCleveland, MS, United StatesContract manufacturer0000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer0092api.fda.gov
Becton, Dickinson & Co., (BD)Sumter, SC, United StatesManufacturer0000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
CODAN US CorporationSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.)Washington, NC, United StatesManufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesManufacturer for export0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
Fresenius Kabi WarrendaleWarrendale, PA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesManufacturer, Specification developer0000api.fda.gov
Halkey-Roberts CorporationSaint Petersburg, FL, United StatesContract manufacturer0000api.fda.gov
Icu Medical, Inc.San Diego, CA, United StatesSpecification developer0000api.fda.gov
Innovative Medical Technologies, IncOverland Park, KS, United StatesSpecification developer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations Inc.Spartanburg, SC, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations Inc.Chester, NY, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
IntriCon Corporation VHVadnais Heights, MN, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations Inc.Chester, NY, United StatesManufacturer for export0000api.fda.gov
Isomedix Operations, IncOntario, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Kurin, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Magnolia Medical Technologies, Inc.Seattle, WA, United StatesManufacturer0000api.fda.gov
Mannkind CorporationDanbury, CT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov
MFG One, LLCChantilly, VA, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Piccguard, LLCSheboygan, WI, United StatesManufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Retractable Technologies, Inc.Little Elm, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Amery, WI, United StatesContract manufacturer0000api.fda.gov
Smisson-Cartledge Biomedical LLCMacon, GA, United StatesSpecification developer0000api.fda.gov
Sol-Millennium Medical, Inc.Chicago, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sterigenics US LLCFort Worth, TX, United StatesContract manufacturer0000api.fda.gov
Synergy Health AST, LLCSan Diego, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Synergy Health AST, LLCSaxonburg, PA, United StatesManufacturer for export0000api.fda.gov
Zevex, Inc.Salt Lake City, UT, United StatesManufacturer0010api.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.