FDA-Device2025-01-29Class II
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
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
5,120 units (2190 US, 2930 OUS)
Manufactured in
2-6 Mc Donald Street, Morningside, Po Box 10075 Dominion Rd, Auckland, New Zealand
Products
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0967-2025Don't want to check this manually?
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