ClearanceBrief
Company ยท IL

Degania Silicone, Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2026. Name variants (Inc, Corp, punctuation) are merged.

19510(k) clearances (1 in 12 months)
43recalls (0 in 12 months)
33recalls that name a 510(k)

Product codes

CodeDeviceRecords
EZLCatheter, Retention Type, Balloon36
GBXCatheter, Irrigation10
KNTTubes, Gastrointestinal (And Accessories)7
DXCClamp, Vascular2
FPKTubing, Fluid Delivery2
MDAElastomer, Silicone, For Scar Management2
PIFGastrointestinal Tubes With Enteral Specific Connectors2
GAXTourniquet, Nonpneumatic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 20, 2026K254170Percutaneous Endoscopic Gastrostomy (PEG) Kit
Degania Silicone , Ltd., IL
PIF
May 31, 2024K233591Stylus
Degania Silicone , Ltd., IL
KNT
Jun 21, 2016K152246Aquarius Stoma Measuring Device
Degania Silicone , Ltd., IL
KNT
Dec 29, 2014K143378AQUARIUS Gastrostomy Replacement Tube
Degania Silicone , Ltd., IL
KNT
Oct 16, 2014K141753AQUARIUS NASAL FEEDING TUBE
Degania Silicone , Ltd., IL
PIF
Jul 28, 2014K141631AQUARIUS EXTENSION FEEDING SET
Degania Silicone , Ltd., IL
KNT
May 12, 2014K132686AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
Degania Silicone , Ltd., IL
KNT
May 9, 2013K131020TEMPERATURE SENSOR CATHETER
Degania Silicone , Ltd., IL
EZL
Sep 5, 2012K122030LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
Degania Silicone , Ltd., IL
KNT
Mar 11, 2011K103371COUDE/ OR TIEMANN
Degania Silicone , Ltd., IL
EZL
May 23, 2007K070124GASTROSTOMY REPLACEMENT TUBE, MODEL 253
Degania Silicone , Ltd., IL
KNT
Mar 26, 2007K063442ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
Degania Silicone , Ltd., IL
EZL
Jul 9, 1998K981956DEGANIA SILICONE IDENTI LOOPS
Degania Silicone , Ltd., IL
DXC
Jun 24, 1997K971482DEGANIA SILICONE SIL-K
Degania Silicone , Ltd., IL
MDA
Jan 8, 1997K964547DEGANIA SILICONE INDENTI LOOPS
Degania Silicone , Ltd., IL
DXC
Nov 6, 1995K953864SILCLEAR TUBING (MODIFICATION)
Degania Silicone , Ltd., IL
FPK
Mar 16, 1995K943992SILCLEAR TUBING
Degania Silicone , Ltd., IL
FPK
Jan 31, 1992K914701SIL-K
Degania Silicone , Ltd., IL
MDA
Jan 7, 1988K875092DEGANIA SILICONE TOURNIQUET
Degania Silicone , Ltd., IL
GAX

Latest recalls

DateFirm and productCodeLinked 510(k)
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
Jun 28, 2019Degania Silicone, Ltd.
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to in
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fl
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube inten
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube inte
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be use
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube inten
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be u
Terminated
GBXNone listed
Jun 28, 2019Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce no
Terminated
GBXNone 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
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
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
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
EZLK063442
Feb 20, 2018Degania Silicone, Ltd.
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Terminated
GBXNone listed
Feb 22, 2017Degania Silicone, Ltd.
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
Terminated
GBXNone listed
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