Data / Medical devices / Accessories, Catheter / United States

FDA-registered makers of Accessories, Catheter in the United States: 63 establishments

Name: FDA-registered makers of Accessories, Catheter in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

63 establishments in the United States are registered with the FDA to make Accessories, Catheter (product code KGZ). 9 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device: Accessories, Catheter
Product code: KGZ
Country: United States

Makers of Accessories, Catheter in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, United States	Specification developer	2	October 23, 1980	4	api.fda.gov
B. Braun Medical Inc.	Bethlehem, PA, United States	Specification developer	1	November 2, 1976	1	api.fda.gov
B. Braun Us Device Manufacturing LLC	Allentown, PA, United States	Contract manufacturer, Contract sterilizer, Repackager or relabeler	1	November 2, 1976	0	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	Specification developer	1	March 24, 1981	0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Specification developer	1	November 2, 1976	0	api.fda.gov
Deroyal Industries, Inc.	New Tazewell, TN, United States	Contract manufacturer, Repackager or relabeler	1	November 2, 1976	0	api.fda.gov
Implantech Associates, Inc.	Ventura, CA, United States	Manufacturer	1	January 26, 1996	0	api.fda.gov
Mentor	Irving, TX, United States	Specification developer	1	February 10, 1998	0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	1	October 23, 1980	0	api.fda.gov
2G Medical	Belleair, FL, United States	Specification developer	0		0	api.fda.gov
Advanced Vascular Dynamics	Tigard, OR, United States	Manufacturer	0		0	api.fda.gov
Alira Medical Devices LLC	Rancho Cucamonga, CA, United States	Specification developer	0		0	api.fda.gov
Argon Medical Devices Inc.	Athens, TX, United States	Manufacturer	0		0	api.fda.gov
Argon Medical Devices, Inc.	Wheeling, IL, United States	Contract manufacturer	0		0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Atrium Medical Corporation	Merrimack, NH, United States	Specification developer	0		0	api.fda.gov
Baxter Healthcare Corporation	Round Lake, IL, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
Baxter Healthcare Corporation	Cleveland, MS, United States	Manufacturer	0		0	api.fda.gov
Becton Dickinson And Company	Columbus, NE, United States	Manufacturer	0		0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Biotex, Inc.	Houston, TX, United States	Manufacturer	0		0	api.fda.gov
Black & Black Surgical, Inc.	Tucker, GA, United States	Specification developer	0		0	api.fda.gov
Boston Scientific Corporation	Spencer, IN, United States	Manufacturer	0		0	api.fda.gov
Bound Tree Medical, LLC	Grand Prairie, TX, United States	Manufacturer	0		0	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	0		0	api.fda.gov
Cole Instruments	Alpharetta, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Coloplast Manufacturing Us, LLC	Minneapolis, MN, United States	Specification developer	0		0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	0		3	api.fda.gov
Cook Incorporated	Spencer, IN, United States	Manufacturer	0		0	api.fda.gov
Djo, LLC	Carlsbad, CA, United States	Specification developer	0		0	api.fda.gov
Ethicon, Inc.	Raritan, NJ, United States	Manufacturer	0		0	api.fda.gov
Galt Medical Corp.	Garland, TX, United States	Complaint file establishment, Manufacturer	0		3	api.fda.gov
Genesee Biomedical, Inc.	Denver, CO, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Hart Enterprises, Inc.	Sparta, MI, United States	Contract manufacturer	0		0	api.fda.gov
Health Line International Corporation	Salt Lake City, UT, United States	Specification developer	0		0	api.fda.gov
Hemedex Incorporated	North Waltham, MA, United States	Manufacturer	0		0	api.fda.gov
HK Surgical, Inc.	San Clemente, CA, United States	Specification developer	0		0	api.fda.gov
Icu Medical, Inc	Salt Lake City, UT, United States	Specification developer	0		0	api.fda.gov
Insightra Medical, Inc.	Clarksville, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Jigsaw Medical, LLC	Saint Charles, IL, United States	Specification developer	0		0	api.fda.gov
Kahlo Sciences, LLC	Cambridge, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Kmi Imi Group / Dba: Innovative Med, Inc.	Irvine, CA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Marina Medical Instruments, Inc.	Davie, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Marpac, Inc.	Albuquerque, NM, United States	Manufacturer	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Laredo	Laredo, TX, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Medline Industries, LP - SPT	Waukegan, IL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Medtronic Navigation, Inc.	Lafayette, CO, United States	Manufacturer	0		0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Contract manufacturer, Manufacturer	0		1	api.fda.gov
Micromedics, Inc.	Saint Paul, MN, United States	Manufacturer	0		1	api.fda.gov
MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Mozarc Medical Us LLC	Mansfield, MA, United States	Specification developer	0		0	api.fda.gov
NDH Medical, Inc.	Saint Petersburg, FL, United States	Contract manufacturer	0		0	api.fda.gov
Nolato GW BETHEL	Bethel, VT, United States	Contract manufacturer	0		0	api.fda.gov
Pathway Medtech, LLC.	Santee, CA, United States	Manufacturer	0		0	api.fda.gov
PFM Medical, Inc	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
PMT Corp.	Chanhassen, MN, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Paragon Medical - Mansfield, Bridgemedica	Mansfield, MA, United States	Contract manufacturer	0		0	api.fda.gov
Somavac Medical Solutions, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Summit Medical LLC	Saint Paul, MN, United States	Specification developer	0		0	api.fda.gov
Trinity Sterile, Inc.	Salisbury, MD, United States	Manufacturer	0		0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Uresil, LLC	Skokie, IL, United States	Manufacturer	0		0	api.fda.gov
Viant Medical, Inc.	Grand Rapids, MI, United States	Contract manufacturer	0		0	api.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.