510(k) K061058 ยท ETD Tube, Tympanostomy
NEOZOLINE VENTILATION TUBES
| Applicant | Adept Medical, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jul 12, 2006 |
| Received | Apr 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2; Open, Classified |
ETD | None listed |
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2; Open, Classified |
ETD | None listed |
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; Open, Classified |
ETD | None listed |
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312; Open, Classified |
ETD | None listed |
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2; Open, Classified |
ETD | None listed |
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; Open, Classified |
ETD | None listed |
| Jan 17, 2025 | Adept Medical Ltd Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; Open, Classified |
ETD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.