Adept Medical Ltd
FDA Regulatory Profile
Adept Medical Ltd appears in FDA public data with 8 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0966-2025, Class II) was initiated on November 24, 2024. Its most recent 510(k) clearance was granted on July 12, 2006.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0966-2025 | Class II | Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; | November 24, 2024 |
| Z-0969-2025 | Class II | Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; | November 24, 2024 |
| Z-0968-2025 | Class II | Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2; | November 24, 2024 |
| Z-0965-2025 | Class II | Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2; | November 24, 2024 |
| Z-0970-2025 | Class II | Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; | November 24, 2024 |
| Z-0964-2025 | Class II | Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2; | November 24, 2024 |
| Z-0967-2025 | Class II | Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312; | November 24, 2024 |
| Z-0963-2025 | Class II | Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2; | November 24, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K061058 | NEOZOLINE VENTILATION TUBES | July 12, 2006 |