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

DateFirm and productCodeLinked 510(k)
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inten
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is
Terminated
EZLK063442
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i
Terminated
EZLK063442
Sep 15, 2016C.R. Bard, Inc.
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Terminated
EZLK041983
Sep 15, 2016C.R. Bard, Inc.
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Terminated
EZLK023090
Mar 22, 2016Coloplast Manufacturing US, LLC
Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French ca
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +1
Mar 21, 2016Covidien LLC
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: PP14SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +1
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +1
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +1
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +1
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +1
Mar 21, 2016Covidien LLC
Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442 +2
Mar 21, 2016Covidien LLC
Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLK030813
K063442

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