Miracle-Ear, Inc.
Golden Valley, MN, US
Miracle-Ear, Inc. appears in FDA device records in Golden Valley, MN. FDA records list 65 510(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
- 65
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 65FDA records hold 65 510(k) clearances for Miracle-Ear, Inc. between 1990 and 1997. The busiest year on record is 1990, with 20. The most recent is 1997, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 20 |
| 1991 | 6 |
| 1992 | 2 |
| 1993 | 5 |
| 1994 | 14 |
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972346 | MIRACLE-EAR ITE DIGITAL | ESD | Substantially Equivalent | |
| K972345 | DAHLBERG/MIRACLE-EAR | ESD | Substantially Equivalent | |
| K972344 | MIRACLE-EAR DIGITAL BTE | ESD | Substantially Equivalent | |
| K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) | ESD | Substantially Equivalent | |
| K964419 | MIRACLE - EAR (ITE/ITC/CIC) | ESD | Substantially Equivalent | |
| K965063 | AUDIOTONE (A-552) | ESD | Substantially Equivalent | |
| K965057 | AUDIOTONE (A554H) | ESD | Substantially Equivalent | |
| K965049 | DAHLBERG (A-554) | ESD | Substantially Equivalent | |
| K964669 | MIRACLE-EAR OR AUDIOTONE | ESD | Substantially Equivalent | |
| K964794 | DAHLBERG K-AMP BTE | ESD | Substantially Equivalent | |
| K964530 | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT | ESD | Substantially Equivalent | |
| K960804 | MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC | ESD | Substantially Equivalent | |
| K954119 | MIRACLE EAR MIRAGE | ESD | Substantially Equivalent | |
| K954941 | MIRACLE EAR AND AUDIOTONE | ESD | Substantially Equivalent | |
| K954528 | MIRACLE - EAR MODEL PBP | ESD | Substantially Equivalent | |
| K950693 | MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID | ESD | Substantially Equivalent | |
| K950692 | MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID | ESD | Substantially Equivalent | |
| K950691 | MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID | ESD | Substantially Equivalent | |
| K943960 | UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS | ESD | Substantially Equivalent | |
| K943826 | MIRACLE-EAR MIRAGE | ESD | Substantially Equivalent | |
| K942523 | MIRACLE-EAR IMPRESSION MATERIAL KIT | ESD | Substantially Equivalent | |
| K943825 | MIRACLE EAR CONFIDANTE | ESD | Substantially Equivalent | |
| K941295 | SHARP II HELIX HEARING AID | ESD | Substantially Equivalent | |
| K941294 | SHARP II LOW PROFILE HEARING AID | ESD | Substantially Equivalent | |
| K941293 | SHARP II SEMI CONTOUR HEARING AID | ESD | Substantially Equivalent | |
| K941292 | SHARP II FULL CONTOUR | ESD | Substantially Equivalent | |
| K941122 | AUDIOTONE MODEL A-54SR | ESD | Substantially Equivalent | |
| K941121 | AUDIOTONE MODEL A-54 | ESD | Substantially Equivalent | |
| K941039 | WAX GUARD OPTION | ESD | Substantially Equivalent | |
| K935962 | MIRACLE-EAR WITH POWER CIRCUIT OPTION | ESD | Substantially Equivalent | |
| K940458 | MIRACLE-EAR CONFIDANTE | ESD | Substantially Equivalent | |
| K934940 | MIRACLE-EAR ENTRE | ESD | Substantially Equivalent | |
| K935266 | MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID | ESD | Substantially Equivalent | |
| K935265 | MIRACLE EAR MODEL SHARP II CANAL | ESD | Substantially Equivalent | |
| K934597 | CLARIFIER II CIRCUIT OPTION | ESD | Substantially Equivalent | |
| K926092 | MIRACLE-EAR MODEL HL | ESD | Substantially Equivalent | |
| K926091 | AUDIOTONE MODEL A-98 | ESD | Substantially Equivalent | |
| K920093 | AUDIOTONE MODEL A-96 | ESD | Substantially Equivalent | |
| K920092 | AUDIOTONE MODEL A97 | LYY | Substantially Equivalent | |
| K914477 | AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K911096 | DAHLBERG MODEL LZ BTE HEARING AID | ESD | Substantially Equivalent | |
| K911064 | DAHLBERG MODEL LG BTE HEARING AID | ESD | Substantially Equivalent | |
| K911063 | DAHLBERG MODEL LU BTE HEARING AID | ESD | Substantially Equivalent | |
| K910979 | DAHLBERG MODEL LT BTE HEARING AID | ESD | Substantially Equivalent | |
| K910809 | DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K901783 | AUDIOTONE ITE HEARING AID MODEL ZA (MICRO) | ESD | Substantially Equivalent | |
| K901747 | AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE) | ESD | Substantially Equivalent | |
| K901746 | AUDIOTONE ITE HEARING AID MODEL ZD (XT) | ESD | Substantially Equivalent | |
| K901745 | AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST. | ESD | Substantially Equivalent | |
| K897035 | MIRACLE EAR MODEL PC PROG. IN-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
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Data as of , FDA export datePage updated Source: openFDA, public domain