510(k) K063442 ยท EZL Catheter, Retention Type, Balloon
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
| Applicant | Degania Silicone , Ltd., Emek Hayarden, IL |
| Decision | Substantially Equivalent, Mar 26, 2007 |
| Received | Nov 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Mar 17, 2020 | Degania 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 |
EZL | None listed |
| Dec 2, 2019 | Degania 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 |
EZL | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Jun 21, 2018 | Degania 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 |
EZL | None listed |
| Mar 21, 2016 | Covidien 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 |
KOY | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.