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) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter
REF:
947314
947316
947318
UDI codes:
00801741024924 10801741024921
00801741024931 10801741024938
0 Open, Classified |
EZL | K040504 K070508 +2 |
| May 21, 2026 | C.R. Bard Inc Silastic Foley Catheters
Silastic Brand Foley Catheter 30cc
REF:
33416
33418
33420
33422
33424
Silastic Brand Foley Catheter 5cc
REF:
33614
33616
33618
33620
33622
33624 Open, Classified |
EZL | K951103 |
| Aug 28, 2025 | C.R. Bard Inc Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314;
SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514 Open, Classified |
EZL | K070582 |
| Jan 10, 2025 | Coloplast Manufacturing US, LLC X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, Open, Classified |
EZL | K013172 |
| Jan 10, 2025 | Coloplast Manufacturing US, LLC Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA632 Open, Classified |
EZL | K233411 |
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" Open, Classified |
EZL | K024010 K780062 +1 |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/5163 Open, Classified |
EZL | K030813 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | K040504 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
EZL | K040504 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | K040504 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | K040504 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| May 28, 2019 | Medline Industries Inc SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine Terminated |
EZL | None listed |
| May 28, 2019 | Medline Industries Inc SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine Terminated |
EZL | None listed |
| May 28, 2019 | Medline Industries Inc SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urin Terminated |
EZL | K142635 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
| 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 | K063442 |
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