FDA applicant

Miracle-Ear/Dahlberg, Inc.

Golden Valley, MN23 decisions1985–19940 recalls

FDA records 23 decisions for Miracle-Ear/Dahlberg, Inc. (Golden Valley, MN) from 1985 to 1994: 23 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). No recall is 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 Miracle-Ear/Dahlberg, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Miracle-Ear/Dahlberg, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Miracle-Ear/Dahlberg, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Miracle-Ear/Dahlberg, 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

Other applicant names beginning “Miracle-Ear/Dahlberg”

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

Miracle-Ear, Inc. 65 Miracle Clean, Inc. 1

Miracle-Ear/Dahlberg, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Miracle-Ear/Dahlberg”