ClearanceBrief
Panels › Gastroenterology, Urology › Product code EZL · Class 2

Catheter, Retention Type, Balloon

Regulation 876.5130

4510(k)s in 12 months (131 all time)
2recalls in 12 months (85 all time)
82recalls that name a 510(k)
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Top companies in EZL

Company510(k)sRecalls
Degania Silicone , Ltd.333
Covidien LLC024
C.R. Bard, Inc.109
Degania Medical Devices Pvt. Ltd.011
Medline Industries, Inc.33
Regulatory & Marketing Services, Inc.60
Amsino International, Inc.50
Opticon Medical40
Rusch Intl.40
Teleflexmedical, Inc.40
Decided510(k)Device and applicantCode
Oct 6, 2026K261141OpenFlo Urinary Catheter
Urolution Medical, Inc.
EZL
Sep 4, 2026K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Sentinel Medical Technologies,
EZL
Aug 5, 2026K262056Rusch Latex Gold Foley Catheter
Teleflex Medical Sdn. Bhd., MY
EZL
Jan 20, 2026K252537Rusch SoftSimplastic Foley Catheters
Teleflex Medical Sdn. Bhd., MY
EZL
Jun 16, 2025K243011Silicone Urethral Catheter (Silicone Urethral Catheter)
Guangdong Ecan Medical Co., Ltd., CN
EZL
Sep 18, 2024K241424InnoCare Specialty Foley Catheter
Innocare Urologics, LLC
EZL
Aug 1, 2024K232469Rüsch Latex Gold Foley Catheter
Teleflexmedical, Inc.
EZL
Apr 17, 2024K240057TraumaGuard Intra-abdominal Pressure Sensing System
Sentinel Medical Technologies, LLC
EZL
Apr 15, 2024K233411Folysil Silicone Catheter
Coloplast Corp.
EZL
Jan 23, 2024K2330132-Way 100% Silicone Cleartract Catheter
Silq Technologies Corporation
EZL
Jul 27, 2023K212077Teleflex Rusch SoftSimplastic Foley Catheters
Teleflexmedical, Inc.
EZL
Jun 29, 2023K231101Flume Catheter
Flume Catheter Company, Ltd., GB
EZL
Jan 13, 2023K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 1
Potrero Medical, Inc.
EZL
Dec 1, 2022K2221182-Way 100% Silicone Cleartract Catheter
Silq Technologies, Corp.
EZL
Jul 1, 2022K2216252-Way 100% Silicone ClearTract Catheter
Silq Technologies Corporation
EZL
Nov 3, 2021K212151FLUME catheter
The Flume Catheter Company, Ltd., GB
EZL
Apr 8, 2021K202134Well Lead All Silicone Foley Catheter with Temperature Sensor
Well Lead Medical Co., Ltd., CN
EZL
Dec 30, 2020K201776Foley Balloon Catheter for Urology
Apollon Co., Ltd., KR
EZL
Dec 15, 2020K202698Prefilled Syringe
Hangzhou Primecare Medical Co., Ltd., CN
EZL
Apr 21, 2020K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2
Pathway, LLC
EZL
Mar 31, 2020K200556AquaFlate Pre-Filled Sterile Water Syringe 10mL
H R Pharmaceuticals, Inc.
EZL
Nov 6, 2019K182463Silicone Foley Catheter
Biosensors International Pte, Ltd., SG
EZL
Oct 4, 2019K190060Urethrotech UCD
Urethrotech, GB
EZL
Jan 10, 2019K182635Signal Catheter
Safe Medical Design
EZL
Sep 21, 2018K181616PSM 3-Way Silicone Foley Catheter
Pathway, LLC
EZL
Sep 19, 2018K180781Bard Vertus Foley Catheter
C.R. Bard, Inc.
EZL
Sep 4, 2018K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
Amsino International, Inc.
EZL
Aug 23, 2018K173657Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
Cook Incorporated
EZL
Aug 6, 2018K181346CystoSure Plus Catheter
Emmy Medical, LLC
EZL
Jul 13, 2018K173340Yikang Latex Foley Catheter
Jiangxi Yikang Medical Instrument Group Co., Ltd., CN
EZL
Jun 4, 2018K172807Silicone Foley Catheter for single use
Changzhou Rongxin Medicine Minimal Invasion Technology, CN
EZL
Mar 29, 2018K173533Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Poiesis Medical, LLC
EZL
Feb 9, 2018K172422Kohli Urinary Drainage Catheter
Nellie Medical, LLC
EZL
May 5, 2017K161770Rusch Silicone Foley Catheter
Teleflexmedical, Inc.
EZL
Feb 24, 2017K162989Rusch Simplastic Foley Catheters
Teleflexmedical, Inc.
EZL
Apr 15, 2016K153655Accuryn Monitoring System
Potrero Medical, Inc.
EZL
Nov 24, 2015K150550SilverCoat Silicone Foley Catheter
Covalontechnologies, Inc., CA
EZL
Jul 28, 2015K150699Bard LubriGuard Foley Catheter
C.R. Bard, Inc.
EZL
Jan 9, 2015K142635Medline Silicone Foley Catheter
Medline Industries, Inc.
EZL
Dec 15, 2014K140667WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
Well Lead Medical Co., Ltd., CN
EZL
Mar 4, 2014K140099LIGHTHOUSE URINARY CATHETER
Seedings Life Science Ventures, LLC
EZL
Nov 4, 2013K131655LIGHTHOUSE(TM) URINARY CATHETER
Seedings Life Science Ventures, LLC
EZL
Oct 3, 2013K130908DISPOSABLE SILICONE FOLEY CATHETER
Guangdong Baihe Medical Technology Co., Ltd., CN
EZL
May 9, 2013K131020TEMPERATURE SENSOR CATHETER
Degania Silicone , Ltd., IL
EZL
May 27, 2011K110214DIRECTVISION CATHETER, UNCOATED
Percuvision
EZL
Mar 11, 2011K103371COUDE/ OR TIEMANN
Degania Silicone , Ltd., IL
EZL
Sep 13, 2010K101824AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
Amsino International, Inc.
EZL
Oct 16, 2009K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
Well Lead Medical Co., Ltd.
EZL
Oct 9, 2009K0917673 WAY SILICONE FOLEY BALLOON CATHETER
Cook Urological, Inc.
EZL
Aug 10, 2009K091699AMSURE HYDROPHILIC LATEX FOLEY CATHETER
Amsino International, Inc.
EZL

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