Catheter, Retention Type, Balloon

FDA product code EZL · 125 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5130
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-10-18 – 2026-09-04

EZL 2026-09-04

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

Applicant Sentinel Medical Technologies,

K number K260756

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EZL 2026-08-05

Rusch Latex Gold Foley Catheter

Applicant Teleflex Medical Sdn. Bhd.

K number K262056

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EZL 2026-01-20

Rusch SoftSimplastic Foley Catheters

Applicant Teleflex Medical Sdn. Bhd.

K number K252537

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EZL 2025-06-16

Silicone Urethral Catheter (Silicone Urethral Catheter)

Applicant Guangdong Ecan Medical Co., Ltd.

K number K243011

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EZL 2024-09-18

InnoCare Specialty Foley Catheter

Applicant Innocare Urologics, LLC

K number K241424

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EZL 2024-08-01

Rüsch Latex Gold Foley Catheter

Applicant Teleflexmedical, Inc.

K number K232469

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EZL 2024-04-17

TraumaGuard Intra-abdominal Pressure Sensing System

Applicant Sentinel Medical Technologies, LLC

K number K240057

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EZL 2024-04-15

Folysil Silicone Catheter

Applicant Coloplast Corp.

K number K233411

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EZL 2024-01-23

2-Way 100% Silicone Cleartract Catheter

Applicant Silq Technologies Corporation

K number K233013

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EZL 2023-07-27

Teleflex Rusch SoftSimplastic Foley Catheters

Applicant Teleflexmedical, Inc.

K number K212077

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EZL 2023-06-29

Flume Catheter

Applicant Flume Catheter Company, Ltd.

K number K231101

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EZL 2023-01-13

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F

Applicant Potrero Medical, Inc.

K number K221020

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EZL 2022-12-01

2-Way 100% Silicone Cleartract Catheter

Applicant Silq Technologies, Corp.

K number K222118

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EZL 2022-07-01

2-Way 100% Silicone ClearTract Catheter

Applicant Silq Technologies Corporation

K number K221625

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EZL 2021-11-03

FLUME catheter

Applicant The Flume Catheter Company, Ltd.

K number K212151

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EZL 2021-04-08

Well Lead All Silicone Foley Catheter with Temperature Sensor

Applicant Well Lead Medical Co., Ltd.

K number K202134

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EZL 2020-12-30

Foley Balloon Catheter for Urology

Applicant Apollon Co., Ltd.

K number K201776

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EZL 2020-12-15

Prefilled Syringe

Applicant Hangzhou Primecare Medical Co., Ltd.

K number K202698

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EZL 2020-04-21

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Applicant Pathway, LLC

K number K192034

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EZL 2020-03-31

AquaFlate Pre-Filled Sterile Water Syringe 10mL

Applicant H R Pharmaceuticals, Inc.

K number K200556

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EZL 2019-11-06

Silicone Foley Catheter

Applicant Biosensors International Pte, Ltd.

K number K182463

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EZL 2019-10-04

Urethrotech UCD

Applicant Urethrotech

K number K190060

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EZL 2019-01-10

Signal Catheter

Applicant Safe Medical Design

K number K182635

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EZL 2018-09-21

PSM 3-Way Silicone Foley Catheter

Applicant Pathway, LLC

K number K181616

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EZL 2018-09-19

Bard Vertus Foley Catheter

Applicant C.R. Bard, Inc.

K number K180781

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EZL 2018-09-04

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

Applicant Amsino International, Inc.

K number K181814

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EZL 2018-08-23

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

Applicant Cook Incorporated

K number K173657

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EZL 2018-08-06

CystoSure Plus Catheter

Applicant Emmy Medical, LLC

K number K181346

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EZL 2018-07-13

Yikang Latex Foley Catheter

Applicant Jiangxi Yikang Medical Instrument Group Co., Ltd.

K number K173340

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EZL 2018-06-04

Silicone Foley Catheter for single use

Applicant Changzhou Rongxin Medicine Minimal Invasion Technology

K number K172807

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EZL 2018-03-29

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter

Applicant Poiesis Medical, LLC

K number K173533

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EZL 2018-02-09

Kohli Urinary Drainage Catheter

Applicant Nellie Medical, LLC

K number K172422

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EZL 2017-05-05

Rusch Silicone Foley Catheter

Applicant Teleflexmedical, Inc.

K number K161770

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EZL 2017-02-24

Rusch Simplastic Foley Catheters

Applicant Teleflexmedical, Inc.

K number K162989

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EZL 2016-04-15

Accuryn Monitoring System

Applicant Potrero Medical, Inc.

K number K153655

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EZL 2013-11-04

LIGHTHOUSE(TM) URINARY CATHETER

Applicant Seedings Life Science Ventures, LLC

K number K131655

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EZL 2013-10-03

DISPOSABLE SILICONE FOLEY CATHETER

Applicant Guangdong Baihe Medical Technology Co., Ltd.

K number K130908

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EZL 2013-05-09

TEMPERATURE SENSOR CATHETER

Applicant Degania Silicone , Ltd.

K number K131020

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EZL 2011-05-27

DIRECTVISION CATHETER, UNCOATED

Applicant Percuvision

K number K110214

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EZL 2011-03-11

COUDE/ OR TIEMANN

Applicant Degania Silicone , Ltd.

K number K103371

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EZL 2010-09-13

AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

Applicant Amsino International, Inc.

K number K101824

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EZL 2009-10-16

WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR

Applicant Well Lead Medical Co., Ltd.

K number K091516

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EZL 2009-10-09

3 WAY SILICONE FOLEY BALLOON CATHETER

Applicant Cook Urological, Inc.

K number K091767

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EZL 2009-08-10

AMSURE HYDROPHILIC LATEX FOLEY CATHETER

Applicant Amsino International, Inc.

K number K091699

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EZL 2009-05-28

PERCUCATH URINARY CATHETER

Applicant Percuvision, LLC

K number K090262

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EZL 2008-10-27

UC-CARE POSITIONING SYSTEM

Applicant Uc-Care Medical Systems, Ltd.

K number K082919

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EZL 2008-10-08

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS

Applicant Well Lead Medical Instruments

K number K082815

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EZL 2007-12-07

BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS

Applicant C.R. Bard, Inc.

K number K070582

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EZL 2007-12-07

BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS

Applicant C.R. Bard, Inc.

K number K070558

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EZL 2007-10-16

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR

Applicant Tyco Healthcare

K number K071049

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EZL 2007-07-18

MEDLINE LATEX FOLEY CATHETER

Applicant Medline Industries, Inc.

K number K071423

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EZL 2007-06-04

SUNMED FOLEY CATHETERS

Applicant Sunmed, Inc.

K number K062112

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EZL 2007-03-26

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

Applicant Degania Silicone , Ltd.

K number K063442

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EZL 2007-03-09

BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR

Applicant C.R. Bard, Inc.

K number K070508

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EZL 2006-02-16

MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.

Applicant Medline Industries, Inc.

K number K052168

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EZL 2006-02-08

ADVANCED UROLOGICAL CATHETER

Applicant Entracare, LLC

K number K053429

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EZL 2005-06-28

AMSURE 100% SILICONE FOLEY CATHETER

Applicant Amsino International, Inc.

K number K051059

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EZL 2005-02-25

BEAMCATH

Applicant Beampoint AB

K number K042110

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EZL 2005-01-18

DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER

Applicant Tyco Healthcare

K number K042709

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EZL 2004-11-17

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016

Applicant Opticon Medical

K number K041983

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EZL 2004-05-14

BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS

Applicant C.R. Bard, Inc.

K number K040504

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EZL 2004-01-09

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000

Applicant Opticon Medical, Inc.

K number K033830

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EZL 2003-10-29

AMSURE FOLEY CATHETER

Applicant Amsino International, Inc.

K number K030120

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EZL 2003-08-27

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES

Applicant Vitalcare Group, Inc.

K number K031748

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EZL 2003-06-11

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

Applicant The Kendall Company Div. of Tyco Healthcare Group

K number K024010

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EZL 2003-05-30

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

Applicant Primary Care Solutions, Inc.

K number K030813

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EZL 2003-04-22

VITALCARE FOLEY CATHETER

Applicant Vitalcare, Inc.

K number K021939

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EZL 2003-03-19

OPTION-VF URINARY CATHETER, FV14218

Applicant Opticon Medical, Inc.

K number K023090

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EZL 2002-10-01

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

Applicant Fortune Medical Instrument Corp.

K number K021142

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EZL 2002-09-23

3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

Applicant 3t Medical Systems, LLC

K number K022287

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EZL 2002-09-03

BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON

Applicant C.R. Bard, Inc.

K number K002612

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EZL 2002-02-15

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

Applicant Sewoon Medical Co., Ltd.

K number K013276

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EZL 2002-01-04

PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,

Applicant Porges S.A.

K number K013174

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EZL 2001-12-20

PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

Applicant Porges S.A.

K number K013172

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EZL 2001-07-25

DRAINAGE CATHETER OR FOLEY CATHETER

Applicant Applied Medical Resources Corp.

K number K010006

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EZL 2001-03-05

MENTOR SELF-CATH PLUS

Applicant Mentor Corp.

K number K003784

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EZL 2001-01-05

BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU

Applicant C.R. Bard, Inc.

K number K003289

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EZL 2000-12-08

BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER

Applicant C.R. Bard, Inc.

K number K002868

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EZL 1999-12-09

RUSCH BRILLANT SILICONE FOLEY

Applicant Rusch Intl.

K number K993063

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EZL 1999-09-28

KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C

Applicant The Kendal Co.

K number K990500

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EZL 1999-05-18

OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818

Applicant Implemed, Inc.

K number K990509

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EZL 1999-02-01

BARDEX LUBRI-SIL FOLEY CATHETER

Applicant Bard Medical Div.

K number K984084

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EZL 1998-10-28

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER

Applicant Mri Manufacturing and Research, Inc.

K number K982970

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EZL 1998-09-16

EUROMEDICAL HAEMATURIA FOLEY CATHETER

Applicant Unomedical Sdn Bhd

K number K973076

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EZL 1998-08-20

URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0

Applicant Medworks Corp.

K number K982626

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EZL 1998-07-08

ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER

Applicant Rochester Medical Corp.

K number K981612

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EZL 1998-06-09

RUSCH SILICONE FOLEY CATHETER

Applicant Rusch, Inc.

K number K980870

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EZL 1998-03-31

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

Applicant Fortune Medical Instrument Corp.

K number K980919

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EZL 1998-01-27

RUSCH SIMPLASTIC COUNCILL TIP CATHETER

Applicant Rusch, Inc.

K number K974419

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EZL 1998-01-08

RUSCH BRILLANT SILICONE FOLEY CATHETER

Applicant Rusch Intl.

K number K972184

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EZL 1997-10-07

RUSCH BRILLANT BALLOON CATHETER

Applicant Rusch Intl.

K number K971643

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EZL 1997-08-12

LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS

Applicant Louisville Laboratories, Inc.

K number K971796

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EZL 1997-07-22

LAPAROTOMY BLADDER NECK SUSPENSION KIT

Applicant Louisville Laboratories, Inc.

K number K971801

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EZL 1997-06-25

CONTIDRAIN CATHETER

Applicant Contimed, Inc.

K number K964757

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EZL 1997-05-16

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE

Applicant Opticon Medical, Inc.

K number K970716

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EZL 1997-02-04

SYMPACATH HYDROGEL COATED FOLEY

Applicant Rusch Intl.

K number K964575

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EZL 1996-08-30

OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE

Applicant Medical Device Intl., Inc.

K number K961697

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EZL 1996-04-10

MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

Applicant Regulatory & Marketing Services, Inc.

K number K944673

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EZL 1996-04-05

MRI'S ALL SILICONE FOLEY CATHETER

Applicant Mri Manufacturing and Research, Inc.

K number K944676

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EZL 1995-10-30

PEDIATRIC EUROPHYLIC FOLEY CATHETER

Applicant Regulatory & Marketing Services, Inc.

K number K954752

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