Medical Device Manufacturer · US , Mchenry , IL

Oticon Corp.

57 submissions · 57 cleared · Since 1978
57
Total
57
Cleared
0
Denied

Oticon Corp. — FDA 510(k) Submissions

Oticon Corp. has submitted 57 FDA 510(k) premarket notifications since 1978, of which 57 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Otoscope, Binder, Abdominal . Use the specialty filter in the sidebar to narrow results.

57 devices
1–25 of 57
PRIMOFOCUS COMPACT
K963788 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 68d
OTICON MF
K932670 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1993 64d
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
K923388 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1992 30d
BTE HEARING AID PERSONIC 410
K923490 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1992 22d
BTE HEARING AID PERSONIC 425
K923491 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1992 23d
A-ZILICONE
K905555 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1992 573d
OTICAON BTE MODEL E34P
K904673 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1990 20d
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
K902559 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1990 28d
CUSTOM ITE HEARING AID MODELS C AND M
K902351 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1990 16d
CUSTOM ITE HEARING AID MODEL: H
K902352 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1990 16d
CUSTOM ITE HEARING AID MODELS F AND L
K902353 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1990 16d
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
K901292 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1990 21d
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
K895140 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1989 56d
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1989 99d
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
K890703 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1989 35d
BTE HEARING AID OTICON MODEL: E42P
K890704 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1989 27d
OTICON HEARING AID MODEL I52
K874651 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1988 67d
BTE HEARING AID OTICON MODEL E38P
K874380 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1987 64d
BTE HEARING AID OTICON MODEL E39PL
K874381 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1987 58d
OTICON MODEL I50 IN-THE-EAR HEARING AID
K874744 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1987 22d
BEHIND-THE-EAR HEARING AID OTICON E40
K872372 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1987 42d
BTE HEARING AID OTICON MODEL E30P
K872017 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1987 13d
OTICON I31 INITIALES HEARING AID
K862981 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1986 69d
OTICON I31 CITE HEARING AID
K862980 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1986 19d
I81 INITIALES
K862623 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1986 28d
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