ClearanceBrief
510(k) K063442 ยท EZL Catheter, Retention Type, Balloon

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

ApplicantDegania Silicone , Ltd., Emek Hayarden, IL
DecisionSubstantially Equivalent, Mar 26, 2007
ReceivedNov 14, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K063442

DateFirm and productCodeLinked 510(k)
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Mar 17, 2020Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Terminated
EZLNone listed
Dec 2, 2019Degania Silicone, Ltd.
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drain
Terminated
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third l
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int
Terminated
EZLNone listed
Jun 21, 2018Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
KOYNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
EZLNone listed
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
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
EZLNone listed

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