FDA-Device2025-01-29Class II
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Adept Medical Ltd
Hazard
Lack of 510(k) clearance.
Sold states
US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
Affected count
13,070 units (9090 US, 3980 OUS)
Manufactured in
2-6 Mc Donald Street, Morningside, Po Box 10075 Dominion Rd, Auckland, New Zealand
Products
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2025Don't want to check this manually?
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