510(k) Report

FDA applicant

Adept Medical, Ltd.

Auckland, NZ1 decision2006–20067 recalls

FDA records 1 decision for Adept Medical, Ltd. (Auckland, NZ) in 2006: 1 510(k) clearance. All are in product code ETD (Tube, Tympanostomy). 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Adept Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adept Medical, Ltd. since 2007.

Recalls per year

7in 2024

2024: 7
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Adept Medical, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Adept”

FDA records each applicant name separately; these may or may not be the same firm.