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Data / Medical devices / Catheter, Retention Type, Balloon / United States

FDA-registered makers of Catheter, Retention Type, Balloon in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Catheter, Retention Type, Balloon (product code EZL). 16 have a 510(k) clearance or PMA approval on file and 3 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.

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Device
Catheter, Retention Type, Balloon
Product code
EZL
Country
United States

Makers of Catheter, Retention Type, Balloon in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
C.R. Bard, Inc.Covington, GA, United StatesComplaint file establishment, Contract sterilizer, Manufacturer, Specification developer8September 19, 2018050api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer6October 16, 2007000api.fda.gov
HR PHARMACEUTICALS, INC d/b/a HR HealthCareYork, PA, United StatesComplaint file establishment, Manufacturer, Specification developer6April 8, 2021000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer5August 1, 2024000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer4January 9, 2015010api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer2October 9, 2009000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer2October 9, 2009000api.fda.gov
Emmy Medical, LLCWeston, MA, United StatesSpecification developer2August 6, 2018000api.fda.gov
Greystone Medical, LLCWaterford, MI, United StatesSpecification developer2October 3, 2013000api.fda.gov
Potrero Medical, Inc.Hayward, CA, United StatesManufacturer2January 13, 2023000api.fda.gov
Sentinel Medical Technologies, LLCJacksonville, FL, United StatesComplaint file establishment, Manufacturer, Specification developer2September 4, 2026000api.fda.gov
Ablexan CorporationRaleigh, NC, United StatesManufacturer, Repackager or relabeler1March 26, 2007000api.fda.gov
Edm Imaging Usa LLCDavie, FL, United StatesSpecification developer1October 8, 2008000api.fda.gov
InnoCare UrologicsMiami, FL, United StatesComplaint file establishment, Specification developer1September 18, 2024000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer1May 30, 2003011api.fda.gov
Silq Technologies CorporationSunny Isles Beach, FL, United StatesManufacturer1April 21, 2020000api.fda.gov
Cathtek LLCWalkertown, NC, United StatesContract manufacturer0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Tecan Cdmo Solutions MH, Corp.Morgan Hill, CA, 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.