Company
Degania Medical Devices Pvt. Ltd.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |