Adept Medical Ltd

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0966-2025Class IIOtological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;November 24, 2024
Z-0969-2025Class IIOtological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;November 24, 2024
Z-0970-2025Class IIOtological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;November 24, 2024
Z-0965-2025Class IIOtological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;November 24, 2024
Z-0964-2025Class IIOtological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;November 24, 2024
Z-0967-2025Class IIOtological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;November 24, 2024
Z-0963-2025Class IIOtological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;November 24, 2024
Z-0968-2025Class IIOtological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;November 24, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K061058NEOZOLINE VENTILATION TUBESJuly 12, 2006