Data / Medical devices / Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days / United States
FDA-registered makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days in the United States: 39 establishments
39 establishments in the United States are registered with the FDA to make Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ). 34 have a 510(k) clearance or PMA approval on file and 12 have a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Product code
- FOZ
- Country
- United States
Makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton Dickinson Infusion Therapy Systems Inc. | Sandy, UT, United States | Manufacturer, Specification developer | 15 | April 2, 2026 | 0 | 11 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 10 | March 14, 2025 | 0 | 31 | 1 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 10 | July 29, 2024 | 0 | 2 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 10 | May 17, 2019 | 0 | 6 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 7 | February 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| MedSource Labs, LLC | Chanhassen, MN, United States | Complaint file establishment, Specification developer | 7 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 6 | June 30, 2016 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 6 | August 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 5 | July 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Vascular | Warren, NJ, United States | Manufacturer, Specification developer | 5 | May 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 5 | August 29, 2022 | 0 | 1 | 0 | api.fda.gov |
| ICU Medical, Inc. | Southington, CT, United States | Manufacturer | 4 | June 30, 2016 | 0 | 0 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 3 | March 22, 1995 | 0 | 0 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 3 | March 22, 1995 | 0 | 0 | 0 | api.fda.gov |
| Skydance Vascular, Inc. | Pleasant Grove, UT, United States | Complaint file establishment, Specification developer | 3 | May 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vygon MFG | Dover, NH, United States | Manufacturer | 3 | August 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 2 | January 23, 2002 | 0 | 5 | 0 | api.fda.gov |
| Haolang Medical Usa Corporation | Clyde Hill, WA, United States | Specification developer | 2 | August 20, 2014 | 0 | 0 | 0 | api.fda.gov |
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer, Manufacturer for export | 2 | March 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 2 | July 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | February 23, 2001 | 0 | 0 | 0 | api.fda.gov |
| Access Vascular, Inc | Billerica, MA, United States | Manufacturer | 1 | March 27, 2025 | 0 | 3 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 1 | December 30, 2003 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 1 | May 18, 2012 | 0 | 1 | 1 | api.fda.gov |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer, Repackager or relabeler | 1 | May 18, 2012 | 0 | 1 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | October 2, 1991 | 0 | 0 | 0 | api.fda.gov |
| Ecomed Solutions, LLC | Lindenhurst, IL, United States | Complaint file establishment, Specification developer | 1 | August 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Contract manufacturer, Manufacturer | 1 | December 30, 2003 | 0 | 2 | 0 | api.fda.gov |
| Exelint International, Co. | Redondo Beach, CA, United States | Manufacturer, Specification developer | 1 | February 16, 1990 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Luther Needlesafe Products LLC | Laguna Hills, CA, United States | Manufacturer | 1 | April 30, 2013 | 0 | 0 | 0 | api.fda.gov |
| Primrose Medical, Inc. | East Walpole, MA, United States | Manufacturer | 1 | August 4, 1988 | 0 | 0 | 0 | api.fda.gov |
| Retractable Technologies, Inc. | Little Elm, TX, United States | Complaint file establishment, Manufacturer | 1 | November 7, 2008 | 0 | 0 | 0 | api.fda.gov |
| Venocare, Inc. | Doral, FL, United States | Complaint file establishment, Specification developer | 1 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angiodynamics, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, 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.