Medical Device Manufacturer · US , Golden Valley , MN

Miracle-Ear, Inc. - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 1990

Total

Cleared

Denied

Miracle-Ear, Inc. has 65 FDA 510(k) cleared ear, nose, throat devices. Based in Golden Valley, US.

Historical record: 65 cleared submissions from 1990 to 1997.

Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.

Miracle-Ear, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Miracle-Ear, Inc.

65 devices

1-12 of 65

Cleared Jul 23, 1997

MIRACLE-EAR DIGITAL BTE

K972344 · ESD

Ear, Nose, Throat · 29d

Cleared Jul 23, 1997

DAHLBERG/MIRACLE-EAR

K972345 · ESD

Ear, Nose, Throat · 29d

Cleared Jul 23, 1997

MIRACLE-EAR ITE DIGITAL

K972346 · ESD

Ear, Nose, Throat · 29d

Cleared Mar 31, 1997

MULTI-CHANNEL COMPRESSION BTE (SD)

K970262 · ESD

Ear, Nose, Throat · 67d

Cleared Feb 04, 1997

MIRACLE - EAR (ITE/ITC/CIC)

K964419 · ESD

Ear, Nose, Throat · 126d

Cleared Jan 27, 1997

DAHLBERG (A-554)

K965049 · ESD

Ear, Nose, Throat · 40d

Cleared Jan 27, 1997

AUDIOTONE (A554H)

K965057 · ESD

Ear, Nose, Throat · 40d

Cleared Jan 27, 1997

AUDIOTONE (A-552)

K965063 · ESD

Ear, Nose, Throat · 40d

Cleared Dec 26, 1996

MIRACLE-EAR OR AUDIOTONE

K964669 · ESD

Ear, Nose, Throat · 35d

Cleared Dec 23, 1996

DAHLBERG K-AMP BTE

K964794 · ESD

Ear, Nose, Throat · 24d

Cleared Nov 27, 1996

DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT

K964530 · ESD

Ear, Nose, Throat · 15d

Cleared Apr 05, 1996

MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC

K960804 · ESD

Ear, Nose, Throat · 37d

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Miracle-Ear, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Miracle-Ear, Inc.

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