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)
Top companies in EZL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Jun 21, 2018 | Degania 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 |
EZL | K063442 |
| Sep 15, 2016 | C.R. Bard, Inc. Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. Terminated |
EZL | K041983 |
| Sep 15, 2016 | C.R. Bard, Inc. Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. Terminated |
EZL | K023090 |
| Mar 22, 2016 | Coloplast 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 |
EZL | None listed |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +1 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 +2 |
| Mar 21, 2016 | Covidien 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 |
EZL | K030813 K063442 |
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