FDA applicant
Danavox, Inc.
FDA records 26 decisions for Danavox, Inc. (Mchenry, IL) from 1977 to 1994: 26 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and KLW (Masker, Tinnitus). 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 Danavox, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Danavox, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Danavox, 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