Skip to the page

Data / Medical devices / Catheter, Urological / United States

FDA-registered makers of Catheter, Urological in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Catheter, Urological (product code KOD). 14 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 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
Catheter, Urological
Product code
KOD
Country
United States

Makers of Catheter, Urological in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer10June 28, 2018000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer9June 28, 2018010api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesComplaint file establishment, Contract sterilizer, Manufacturer, Specification developer8February 23, 2026080api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer8July 20, 2004000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer6May 24, 2019060api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer3April 10, 2018000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer2March 10, 1987000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2March 10, 1987000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer2January 9, 2004000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer2July 21, 1982000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer, Manufacturer for export1October 13, 2022000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer1August 10, 1983000api.fda.gov
HR PHARMACEUTICALS, INC d/b/a HR HealthCareYork, PA, United StatesComplaint file establishment, Specification developer1July 17, 2008000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer1March 17, 1983020api.fda.gov
A+ Secure PackagingLa Vergne, TN, United StatesContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Cook Medical LLCBloomington, IN, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Xeridiem Medical DevicesTucson, AZ, 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.