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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Set, Administration, Intravascular
- Product code
- FPA
- Country
- United States
Makers of Set, Administration, Intravascular in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 29 | July 24, 2025 | 0 | 3 | 0 | api.fda.gov |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 27 | January 6, 2017 | 0 | 12 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 26 | March 14, 2025 | 0 | 24 | 1 | api.fda.gov |
| Carefusion | San Diego, CA, United States | Specification developer | 23 | October 30, 2025 | 0 | 3 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 22 | June 5, 2025 | 0 | 12 | 1 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 17 | August 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Multi-Med, Inc. | Keene, NH, United States | Contract manufacturer, Manufacturer | 16 | July 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 13 | August 18, 2016 | 0 | 4 | 0 | api.fda.gov |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 13 | May 2, 2012 | 0 | 1 | 0 | api.fda.gov |
| Nexus Medical, LLC | Lenexa, KS, United States | Contract manufacturer, Manufacturer, Specification developer | 12 | July 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| Vygon MFG | Dover, NH, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 12 | May 2, 2012 | 0 | 9 | 0 | api.fda.gov |
| Douglas Medical Products, Inc | Mundelein, IL, United States | Complaint file establishment, Specification developer | 11 | July 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Exelint International, Co. | Redondo Beach, CA, United States | Manufacturer, Specification developer | 10 | October 17, 2012 | 0 | 1 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 10 | December 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 10 | August 22, 2024 | 0 | 4 | 1 | api.fda.gov |
| Quest Medical, Inc. | Allen, TX, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 9 | December 18, 2024 | 0 | 2 | 0 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer for export, Specification developer | 8 | August 10, 2016 | 0 | 7 | 1 | api.fda.gov |
| Baxter Healthcare of Puerto Rico LLC | Aibonito, PR, United States | Manufacturer | 7 | October 8, 2013 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 6 | September 21, 1995 | 0 | 1 | 0 | api.fda.gov |
| Codan Us Corp. | Santa Ana, CA, United States | Contract manufacturer, Manufacturer | 5 | October 21, 2004 | 0 | 2 | 0 | api.fda.gov |
| MPS Pharma & Medical, Inc. | Brea, CA, United States | Manufacturer | 5 | November 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| NP Medical | Clinton, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | December 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Emed Technologies Corporation | El Dorado Hills, CA, United States | Specification developer | 4 | May 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer, Repackager or relabeler | 3 | June 9, 2011 | 0 | 19 | 2 | api.fda.gov |
| Primrose Medical, Inc. | East Walpole, MA, United States | Manufacturer | 3 | September 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| 410 Medical Inc. | Durham, NC, United States | Complaint file establishment, Specification developer | 2 | May 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 2 | March 29, 2002 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 2 | September 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 2 | June 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 2 | March 29, 2002 | 0 | 1 | 0 | api.fda.gov |
| Becton Dickinson Infusion Therapy Systems Inc. | Sandy, UT, United States | Contract sterilizer, Manufacturer, Specification developer | 2 | February 23, 2021 | 0 | 1 | 0 | api.fda.gov |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Repackager or relabeler | 2 | February 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Indianola, PA, United States | Complaint file establishment, Manufacturer | 2 | June 5, 2009 | 0 | 2 | 0 | api.fda.gov |
| Dragon Heart Medical, Inc. | Elmhurst, IL, United States | Specification developer | 2 | November 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Health Line International Corporation | Salt Lake City, UT, United States | Specification developer | 2 | August 31, 2007 | 0 | 0 | 0 | api.fda.gov |
| Innovative Health Sciences | Chester, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | March 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Koru Medical Systems, Inc. | Mahwah, NJ, United States | Manufacturer, Manufacturer for export, Specification developer | 2 | May 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | January 8, 2014 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 2 | December 23, 2008 | 0 | 2 | 0 | api.fda.gov |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 2 | August 16, 1993 | 0 | 2 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Manufacturer, Repackager or relabeler | 2 | August 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| RyMed Technologies, LLC | Austin, TX, United States | Specification developer | 2 | July 29, 2010 | 0 | 2 | 0 | api.fda.gov |
| Us Infusion LLC. D/B/A Truecare Biomedix-Usa | South Miami, FL, United States | Complaint file establishment, Specification developer | 2 | June 8, 2012 | 0 | 1 | 0 | api.fda.gov |
| Yukon Medical, LLC | Durham, NC, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | June 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zyno Medical LLC. | Natick, MA, United States | Manufacturer, Specification developer | 2 | January 23, 2014 | 0 | 2 | 0 | api.fda.gov |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 1 | May 1, 1990 | 0 | 0 | 0 | api.fda.gov |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | July 14, 1995 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer, Manufacturer | 1 | June 29, 1998 | 0 | 0 | 0 | api.fda.gov |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | Morrisville, NC, United States | Specification developer | 1 | July 10, 2006 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | January 26, 1996 | 0 | 2 | 0 | api.fda.gov |
| Biomedix Wai | Chanhassen, MN, United States | Complaint file establishment, Specification developer | 1 | August 29, 2014 | 0 | 1 | 0 | api.fda.gov |
| BiometerPlus USA, Inc. | Fremont, CA, United States | Specification developer | 1 | August 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 1 | June 23, 2011 | 0 | 1 | 0 | api.fda.gov |
| Custom Assemblies, Inc. | Pine Level, NC, United States | Manufacturer | 1 | January 4, 2000 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | March 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 1 | August 20, 1981 | 0 | 0 | 0 | api.fda.gov |
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 1 | August 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Directmed, Inc. | Glen Cove, NY, United States | Complaint file establishment, Specification developer | 1 | May 28, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ecomed Solutions, LLC | Lindenhurst, IL, United States | Complaint file establishment, Specification developer | 1 | June 11, 2009 | 0 | 0 | 0 | api.fda.gov |
| Epimed International, Inc. | Johnstown, NY, United States | Manufacturer | 1 | July 12, 2002 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Kabi USA, LLC | North Andover, MA, United States | Manufacturer, Specification developer | 1 | November 10, 2021 | 0 | 2 | 2 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 1 | May 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Genesisbps LLC | Mahwah, NJ, United States | Specification developer | 1 | February 13, 2009 | 0 | 0 | 0 | api.fda.gov |
| Haolang Medical Usa Corporation | Clyde Hill, WA, United States | Specification developer | 1 | May 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Intl. Medical Industries | Pompano Beach, FL, United States | Manufacturer | 1 | January 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Mcguff Company, Inc. | Santa Ana, CA, United States | Specification developer | 1 | August 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Manufacturer | 1 | October 6, 1989 | 0 | 2 | 0 | api.fda.gov |
| Medsafety Solutions LLC | Centennial, CO, United States | Complaint file establishment, Specification developer | 1 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 1 | August 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer, Repackager or relabeler | 1 | May 30, 1985 | 0 | 0 | 0 | api.fda.gov |
| Neochild, LLC | Oklahoma City, OK, United States | Specification developer | 1 | February 5, 2001 | 0 | 0 | 0 | api.fda.gov |
| Norfolk Medical Products, Inc. | Skokie, IL, United States | Manufacturer | 1 | February 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| Procedure Products, Inc. | Vancouver, WA, United States | Manufacturer | 1 | May 21, 1981 | 0 | 0 | 0 | api.fda.gov |
| Spectra Medical Devices, LLC | Wilmington, MA, United States | Specification developer | 1 | May 30, 1989 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | December 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Tandem Diabetes Care, Inc. | Irvine, CA, United States | Specification developer | 1 | August 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Takeda Pharmaceuticals U.S.A., Inc. | Lexington, MA, United States | Specification developer | 1 | June 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Wall Medical, Inc. | Buford, GA, United States | Specification developer | 1 | March 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Cleveland, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 9 | 2 | api.fda.gov | |
| Becton, Dickinson & Co., (BD) | Sumter, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CODAN US Corporation | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.) | Washington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| EPIC MedTec OEM Catheter & Wire LLC | Plymouth, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesee Biomedical, Inc. | Denver, CO, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Halkey-Roberts Corporation | Saint Petersburg, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc. | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Medical Technologies, Inc | Overland Park, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Chester, NY, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| IntriCon Corporation VH | Vadnais Heights, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Chester, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc | Ontario, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kurin, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnolia Medical Technologies, Inc. | Seattle, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mannkind Corporation | Danbury, CT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MFG One, LLC | Chantilly, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Needle Specialty Products | Boyle, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piccguard, LLC | Sheboygan, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract 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 | |
| Retractable Technologies, Inc. | Little Elm, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Amery, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smisson-Cartledge Biomedical LLC | Macon, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sol-Millennium Medical, Inc. | Chicago, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics US LLC | Fort Worth, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergy Health AST, LLC | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergy Health AST, LLC | Saxonburg, PA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zevex, Inc. | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 1 | 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.