Degania Silicone, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
43
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0809-2020Class IIMedline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {MedlinDecember 2, 2019
Z-2261-2019Class IICardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An iJune 28, 2019
Z-2260-2019Class IICardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainagJune 28, 2019
Z-2263-2019Class IICardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An intJune 28, 2019
Z-2266-2019Class IIMedline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage cathetJune 28, 2019
Z-2267-2019Class IISmith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introductiJune 28, 2019
Z-2265-2019Class IICardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2June 28, 2019
Z-2264-2019Class IICardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-June 28, 2019
Z-2262-2019Class IICardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-21June 28, 2019
Z-2780-2018Class IIThermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is stJune 21, 2018
Z-2772-2018Class IITemperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD ProducJune 21, 2018
Z-2766-2018Class IIFoley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage:June 21, 2018
Z-2754-2018Class IITemperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sJune 21, 2018
Z-2782-2018Class IITemperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterilJune 21, 2018
Z-2758-2018Class IITemperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterileJune 21, 2018
Z-2755-2018Class IITemperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is stJune 21, 2018
Z-2765-2018Class IIFoley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage:June 21, 2018
Z-2785-2018Class IITemperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterilJune 21, 2018
Z-2759-2018Class IITemperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterileJune 21, 2018
Z-2779-2018Class IIThermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterJune 21, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K233591StylusMay 31, 2024
K152246Aquarius Stoma Measuring DeviceJune 21, 2016
K143378AQUARIUS Gastrostomy Replacement TubeDecember 29, 2014
K141753AQUARIUS NASAL FEEDING TUBEOctober 16, 2014
K141631AQUARIUS EXTENSION FEEDING SETJuly 28, 2014
K132686AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBEMay 12, 2014
K131020TEMPERATURE SENSOR CATHETERMay 9, 2013
K122030LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTONSeptember 5, 2012
K103371COUDE/ OR TIEMANNMarch 11, 2011
K070124GASTROSTOMY REPLACEMENT TUBE, MODEL 253May 23, 2007
K063442ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSORMarch 26, 2007
K981956DEGANIA SILICONE IDENTI LOOPSJuly 9, 1998
K971482DEGANIA SILICONE SIL-KJune 24, 1997
K964547DEGANIA SILICONE INDENTI LOOPSJanuary 8, 1997
K953864SILCLEAR TUBING (MODIFICATION)November 6, 1995
K943992SILCLEAR TUBINGMarch 16, 1995
K914701SIL-KJanuary 31, 1992
K875092DEGANIA SILICONE TOURNIQUETJanuary 7, 1988