Medical Device Manufacturer · US , Golden Valley , MN

Miracle-Ear, Inc.

65 submissions · 65 cleared · Since 1990
65
Total
65
Cleared
0
Denied

Miracle-Ear, Inc. — FDA 510(k) Submissions

Miracle-Ear, Inc. has submitted 65 FDA 510(k) premarket notifications since 1990, of which 65 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Latex Patient Examination Glove . Use the specialty filter in the sidebar to narrow results.

65 devices
1–25 of 65
MIRACLE-EAR DIGITAL BTE
K972344 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1997 29d
DAHLBERG/MIRACLE-EAR
K972345 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1997 29d
MIRACLE-EAR ITE DIGITAL
K972346 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1997 29d
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1997 67d
MIRACLE - EAR (ITE/ITC/CIC)
K964419 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1997 126d
DAHLBERG (A-554)
K965049 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1997 40d
AUDIOTONE (A554H)
K965057 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1997 40d
AUDIOTONE (A-552)
K965063 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1997 40d
MIRACLE-EAR OR AUDIOTONE
K964669 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1996 35d
DAHLBERG K-AMP BTE
K964794 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1996 24d
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
K964530 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 15d
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
K960804 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1996 37d
MIRACLE EAR MIRAGE
K954119 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1996 145d
MIRACLE EAR AND AUDIOTONE
K954941 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1995 53d
MIRACLE - EAR MODEL PBP
K954528 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1995 8d
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
K950691 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 45d
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
K950692 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 45d
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
K950693 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 45d
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
K943960 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1994 66d
MIRACLE-EAR IMPRESSION MATERIAL KIT
K942523 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1994 161d
MIRACLE-EAR MIRAGE
K943826 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1994 49d
MIRACLE EAR CONFIDANTE
K943825 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1994 47d
SHARP II HELIX HEARING AID
K941295 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1994 92d
WAX GUARD OPTION
K941039 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 70d
AUDIOTONE MODEL A-54
K941121 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 64d
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