Medical Device Manufacturer · US , Eden Prairie , MN

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

9 submissions · 9 cleared · Since 1996
9
Total
9
Cleared
0
Denied

Bernafon-Maico, Inc. has 9 FDA 510(k) cleared medical devices. Based in Eden Prairie, US.

Historical record: 9 cleared submissions from 1996 to 1998. Primary specialty: Ear, Nose, Throat.

Browse the FDA 510(k) cleared devices submitted by Bernafon-Maico, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Bernafon-Maico, Inc.

9 devices
1-9 of 9
Cleared Oct 28, 1998
MAICO MA42
K982723 · EWO
Ear, Nose, Throat · 84d
Cleared Apr 22, 1998
MAICO MA53
K981142 · EWO
Ear, Nose, Throat · 23d
Cleared Dec 15, 1997
OPUS 2 - CANAL SERIES (ITC)
K974069 · ESD
Ear, Nose, Throat · 48d
Cleared Dec 15, 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
K974152 · ESD
Ear, Nose, Throat · 41d
Cleared Dec 15, 1997
OPUS 2 - FULL CONCHA SERIES - ITE
K974211 · ESD
Ear, Nose, Throat · 35d
Cleared Oct 28, 1997
DUALINE 100 BTE
K973948 · ESD
Ear, Nose, Throat · 12d
Cleared Jun 13, 1997
DUALINE 400 CIC
K971158 · ESD
Ear, Nose, Throat · 77d
Cleared Jun 06, 1997
MAICO MA52
K971080 · EWO
Ear, Nose, Throat · 73d
Cleared Sep 05, 1996
MAICO MA25 SERIES II WITH SPEECH
K962275 · EWO
Ear, Nose, Throat · 84d
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