FDA applicant
Adept Medical, Ltd.
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
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
Class I Class II/III not classified
Planning a device like Adept Medical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Adept”
FDA records each applicant name separately; these may or may not be the same firm.