Bernafon-Maico, Inc. - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bernafon-Maico, Inc. Ear, Nose, Throat ✕
9 devices
Cleared
Oct 28, 1998
MAICO MA42
Ear, Nose, Throat
84d
Cleared
Apr 22, 1998
MAICO MA53
Ear, Nose, Throat
23d
Cleared
Dec 15, 1997
OPUS 2 - CANAL SERIES (ITC)
Ear, Nose, Throat
48d
Cleared
Dec 15, 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
Ear, Nose, Throat
41d
Cleared
Dec 15, 1997
OPUS 2 - FULL CONCHA SERIES - ITE
Ear, Nose, Throat
35d
Cleared
Oct 28, 1997
DUALINE 100 BTE
Ear, Nose, Throat
12d
Cleared
Jun 13, 1997
DUALINE 400 CIC
Ear, Nose, Throat
77d
Cleared
Jun 06, 1997
MAICO MA52
Ear, Nose, Throat
73d
Cleared
Sep 05, 1996
MAICO MA25 SERIES II WITH SPEECH
Ear, Nose, Throat
84d