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
May 28, 2009K090262PERCUCATH URINARY CATHETER
Percuvision, LLC
EZL
Oct 27, 2008K082919UC-CARE POSITIONING SYSTEM
Uc-Care Medical Systems, Ltd.
EZL
Oct 8, 2008K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
Well Lead Medical Instruments, CN
EZL
Dec 7, 2007K070582BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
C.R. Bard, Inc.
EZL
Dec 7, 2007K070558BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
C.R. Bard, Inc.
EZL
Oct 16, 2007K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
Tyco Healthcare
EZL
Jul 18, 2007K071423MEDLINE LATEX FOLEY CATHETER
Medline Industries, Inc.
EZL
Jun 4, 2007K062112SUNMED FOLEY CATHETERS
Sunmed, Inc.
EZL
Mar 26, 2007K063442ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
Degania Silicone , Ltd., IL
EZL
Mar 9, 2007K070508BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
C.R. Bard, Inc.
EZL
Feb 16, 2006K052168MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
Medline Industries, Inc.
EZL
Feb 8, 2006K053429ADVANCED UROLOGICAL CATHETER
Entracare, LLC
EZL
Jun 28, 2005K051059AMSURE 100% SILICONE FOLEY CATHETER
Amsino International, Inc.
EZL
Feb 25, 2005K042110BEAMCATH
Beampoint AB
EZL
Jan 18, 2005K042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
Tyco Healthcare
EZL
Nov 17, 2004K041983OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
Opticon Medical
EZL
May 14, 2004K040504BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
C.R. Bard, Inc.
EZL
Jan 9, 2004K033830OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
Opticon Medical, Inc.
EZL
Oct 29, 2003K030120AMSURE FOLEY CATHETER
Amsino International, Inc.
EZL
Aug 27, 2003K031748VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
Vitalcare Group, Inc.
EZL
Jun 11, 2003K024010DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
The Kendall Company Div. of Tyco Healthcare Group
EZL
May 30, 2003K030813PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
Primary Care Solutions, Inc.
EZL
Apr 22, 2003K021939VITALCARE FOLEY CATHETER
Vitalcare, Inc.
EZL
Mar 19, 2003K023090OPTION-VF URINARY CATHETER, FV14218
Opticon Medical, Inc.
EZL
Oct 1, 2002K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
Fortune Medical Instrument Corp., TW
EZL
Sep 23, 2002K0222873T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
3t Medical Systems, LLC
EZL
Sep 3, 2002K002612BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
C.R. Bard, Inc.
EZL
Feb 15, 2002K013276ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
Sewoon Medical Co., Ltd.
EZL
Jan 4, 2002K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
Porges S.A., FR
EZL
Dec 20, 2001K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
Porges S.A., FR
EZL
Jul 25, 2001K010006DRAINAGE CATHETER OR FOLEY CATHETER
Applied Medical Resources Corp.
EZL
Mar 5, 2001K003784MENTOR SELF-CATH PLUS
Mentor Corp.
EZL
Jan 5, 2001K003289BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
C.R. Bard, Inc.
EZL
Dec 8, 2000K002868BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER
C.R. Bard, Inc.
EZL
Dec 9, 1999K993063RUSCH BRILLANT SILICONE FOLEY
Rusch Intl.
EZL
Sep 28, 1999K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
The Kendal Co.
EZL
May 18, 1999K990509OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
Implemed, Inc.
EZL
Feb 1, 1999K984084BARDEX LUBRI-SIL FOLEY CATHETER
Bard Medical Div.
EZL
Oct 28, 1998K982970MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
Mri Manufacturing and Research, Inc.
EZL
Sep 16, 1998K973076EUROMEDICAL HAEMATURIA FOLEY CATHETER
Unomedical Sdn Bhd
EZL
Aug 20, 1998K982626URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
Medworks Corp.
EZL
Jul 8, 1998K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
Rochester Medical Corp.
EZL
Jun 9, 1998K980870RUSCH SILICONE FOLEY CATHETER
Rusch, Inc.
EZL
Mar 31, 1998K980919ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
Fortune Medical Instrument Corp.
EZL
Jan 27, 1998K974419RUSCH SIMPLASTIC COUNCILL TIP CATHETER
Rusch, Inc.
EZL
Jan 8, 1998K972184RUSCH BRILLANT SILICONE FOLEY CATHETER
Rusch Intl.
EZL
Oct 7, 1997K971643RUSCH BRILLANT BALLOON CATHETER
Rusch Intl.
EZL
Aug 12, 1997K971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
Louisville Laboratories, Inc.
EZL
Jul 22, 1997K971801LAPAROTOMY BLADDER NECK SUSPENSION KIT
Louisville Laboratories, Inc.
EZL
Jun 25, 1997K964757CONTIDRAIN CATHETER
Contimed, Inc.
EZL

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