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)
Get daily alerts for EZLSample briefCSV

Top companies in EZL

DateFirm and productCodeLinked 510(k)
Sep 4, 2026C.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
EZLK040504
K070508 +2
May 21, 2026C.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
EZLK951103
Aug 28, 2025C.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
EZLK070582
Jan 10, 2025Coloplast 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
EZLK013172
Jan 10, 2025Coloplast 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
EZLK233411
Feb 16, 2024Cardinal 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
EZLK024010
K780062 +1
Dec 20, 2023Nurse 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
EZLK030813
Sep 23, 2021C.R. Bard Inc
Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
Open, Classified
EZLK040504
Sep 23, 2021C.R. Bard Inc
Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
Open, Classified
EZLK040504
Sep 23, 2021C.R. Bard Inc
Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
Open, Classified
EZLK040504
Sep 23, 2021C.R. Bard Inc
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Open, Classified
EZLK040504
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
May 28, 2019Medline 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
EZLNone listed
May 28, 2019Medline 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
EZLNone listed
May 28, 2019Medline 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
EZLK142635
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.