Degania Silicone, Ltd.
Medical device manufacturer in Degania Bet, IL.
19510(k) clearances
0PMA approvals
43recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) KitPIF · Traditional | 03/20/2026SE |
| K233591 | StylusKNT · Traditional | 05/31/2024SE |
| K152246 | Aquarius Stoma Measuring DeviceKNT · Traditional | 06/21/2016SE |
| K143378 | AQUARIUS Gastrostomy Replacement TubeKNT · Special | 12/29/2014SE |
| K141753 | Aquarius Nasal Feeding TubePIF · Traditional | 10/16/2014SE |
| K141631 | Aquarius Extension Feeding SetKNT · Special | 07/28/2014SESK |
| K132686 | Aquarius Low Profile Gastrostomy Feeding TubeKNT · Traditional | 05/12/2014SESK |
| K131020 | Temperature Sensor CatheterEZL · Special | 05/09/2013SE |
| K122030 | Low Profile Gastrostomy Feeding Tube or Gastrotomey ButtonKNT · Traditional | 09/05/2012SE |
| K103371 | Coude/ or TiemannEZL · Traditional | 03/11/2011SE |
| K070124 | Gastrostomy Replacement Tube, Model 253KNT · Traditional | 05/23/2007SE |
| K063442 | All Silicone Foley Catheter, 2-WAY, 3-WAY, with Temperature SensorEZL · Traditional | 03/26/2007SE |
| K981956 | Degania Silicone Identi LoopsDXC · Traditional | 07/09/1998SE |
| K971482 | Degania Silicone Sil-KMDA · Traditional | 06/24/1997SE |
| K964547 | Degania Silicone Indenti LoopsDXC · Traditional | 01/08/1997SE |
| K953864 | Silclear Tubing (Modification)FPK · Traditional | 11/06/1995SE |
| K943992 | Silclear TubingFPK · Traditional | 03/16/1995SE |
| K914701 | Sil-KMDA · Traditional | 01/31/1992SE |
| K875092 | Degania Silicone TourniquetGAX · Traditional | 01/07/1988SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0809-2020 Class II | Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number:…Temperature deviation did not meet release specifications | 12/02/2019Terminated |
| Z-2267-2019 Class II | Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2266-2019 Class II | Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2265-2019 Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2264-2019 Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2263-2019 Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2262-2019 Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2261-2019 Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN:…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2260-2019 Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An…15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection… | 06/28/2019Terminated |
| Z-2785-2018 Class II | Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2784-2018 Class II | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2783-2018 Class II | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2782-2018 Class II | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2781-2018 Class II | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2780-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2779-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2778-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2777-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2776-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2775-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2774-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2773-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2772-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2771-2018 Class II | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2770-2018 Class II | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2769-2018 Class II | Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2768-2018 Class II | Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2767-2018 Class II | Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2766-2018 Class II | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2765-2018 Class II | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2764-2018 Class II | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2763-2018 Class II | Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2762-2018 Class II | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2761-2018 Class II | Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2760-2018 Class II | Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2759-2018 Class II | Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2758-2018 Class II | Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2757-2018 Class II | Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2756-2018 Class II | Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2755-2018 Class II | Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2754-2018 Class II | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-0899-2018 Class III | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234.…Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related… | 10/03/2017Terminated |
| Z-1233-2017 Class II | Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx…Product sterility compromised due to breach of sterile barrier | 01/31/2017Terminated |