Miracle-Ear/Dahlberg, Inc.
Golden Valley, MN, US
Miracle-Ear/Dahlberg, Inc. appears in FDA device records in Golden Valley, MN. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Miracle-Ear/Dahlberg, Inc. between 1985 and 1994. The busiest year on record is 1985, with 10. The most recent is 1994, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 10 |
| 1986 | 9 |
| 1994 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942895 | MIRACLE EAR MODEL PGM | ESD | Substantially Equivalent | |
| K942894 | MIRACLE-EAR MODEL PGC | ESD | Substantially Equivalent | |
| K942893 | MIRACLE-EAR MODEL PGF + REMOTE | ESD | Substantially Equivalent | |
| K941859 | MIRACLE-EAR EAR IMPRESSION MATERIAL | ESD | Substantially Equivalent | |
| K862104 | MODEL UC SPECTRUM IN-THE-CANAL HEARING AID | ESD | Substantially Equivalent | |
| K862103 | MODEL UC IN-THE-CANAL HEARING AID | ESD | Substantially Equivalent | |
| K862102 | MODEL KM IN-THE-CANAL HEARING AID | ESD | Substantially Equivalent | |
| K862101 | MODEL UM IN-THE-CANAL HEARING AID | ESD | Substantially Equivalent | |
| K862100 | MODEL ED BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K862099 | DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K860671 | DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K854835 | DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER | EWO | Substantially Equivalent | |
| K854834 | DAHLBERG MODEL KC IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K853325 | DAHLBERG EC BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K853324 | DAHLBERG EB BEHING-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K853323 | DAHLBERG EA BEHING-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K852486 | DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K852098 | DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID | ESD | Substantially Equivalent for Some Indications | |
| K851869 | DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K851867 | DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K851866 | DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K851810 | MODEL DA BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K851868 | DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID | ESD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Miracle-Ear/Dahlberg, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Miracle-Ear/Dahlberg, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain