Degania Medical Devices Pvt. Ltd.

FDA Regulatory Profile

Degania Medical Devices Pvt. Ltd. appears in FDA public data with 11 recalls, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1788-2020, Class II) was initiated on March 17, 2020.

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1788-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3March 17, 2020
Z-1789-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3March 17, 2020
Z-1782-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3March 17, 2020
Z-1783-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3March 17, 2020
Z-1780-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3March 17, 2020
Z-1787-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3March 17, 2020
Z-1786-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3March 17, 2020
Z-1784-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3March 17, 2020
Z-1785-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3March 17, 2020
Z-1779-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3March 17, 2020
Z-1781-2020Class IITemperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3March 17, 2020