Medical Device Manufacturer · US , Mchenry , IL

Bernafon, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1983
16
Total
16
Cleared
0
Denied

FDA 510(k) Regulatory Record - Bernafon, Inc. Ear, Nose, Throat

16 devices
1-16 of 16
Cleared Mar 07, 1988
MODEL 759 CUSTOM IN-THE-EAR HEARING AID
K880349 · ESD
Ear, Nose, Throat · 41d
Cleared Dec 04, 1987
BERNAFON COLIBRI, C-2H HEARING AIDS
K874589 · ESD
Ear, Nose, Throat · 25d
Cleared Jan 06, 1987
BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1
K864823 · ESD
Ear, Nose, Throat · 28d
Cleared Nov 05, 1986
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
K864180 · ESD
Ear, Nose, Throat · 9d
Cleared Apr 11, 1986
CHARISMA HEARING AID
K860759 · ESD
Ear, Nose, Throat · 42d
Cleared Mar 12, 1986
BEHIND THE EAR HEARING AIDS MODEL
K855240 · ESD
Ear, Nose, Throat · 71d
Cleared May 29, 1985
BEHIND THE EAR HEARING AID MODEL BERNAFON T-82
K851547 · ESD
Ear, Nose, Throat · 43d
Cleared Jan 23, 1985
IN THE EAR MODEL X-ITE 84
K844985 · ESD
Ear, Nose, Throat · 28d
Cleared Jan 07, 1985
BEHIND THE EAR HEARING AID BERNAFON T-88P
K844621 · ESD
Ear, Nose, Throat · 41d
Cleared Jan 04, 1985
BEHIND THE EAR HEARING AIDS BERNAFON X-13
K844425 · ESD
Ear, Nose, Throat · 50d
Cleared Sep 05, 1984
CUSTOM CANAL HEARING AID X-CITE 84
K842546 · ESD
Ear, Nose, Throat · 65d
Cleared Aug 23, 1984
BEHING THE EAR HEARING AID T-98
K842434 · ESD
Ear, Nose, Throat · 64d
Cleared Mar 30, 1984
BEHING-THE-EAR HEARING AID T-85D
K840479 · ESD
Ear, Nose, Throat · 56d
Cleared Mar 30, 1984
BEHIND THE EAR HEARING AID T-97
K840480 · ESD
Ear, Nose, Throat · 56d
Cleared Dec 08, 1983
BEHIND-THE-EAR HEARING AIDS T-87 &
K833775 · ESD
Ear, Nose, Throat · 42d
Cleared May 09, 1983
MODEL BERNAFON T-86
K831217 · ESD
Ear, Nose, Throat · 24d
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