FDA applicant
Ear Tech, Inc.
FDA records 2 decisions for Ear Tech, Inc. (Bradenton, FL) from 1988 to 1993: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and JYG (Curette, Ear). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ear Tech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ear Tech, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ear Tech, Inc.’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) Report