Medical Device Manufacturer · US , Casselberry , FL

Audina Hearing Instrument - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1982
8
Total
8
Cleared
0
Denied

Audina Hearing Instrument has 8 FDA 510(k) cleared medical devices. Based in Casselberry, US.

Historical record: 8 cleared submissions from 1982 to 1997. Primary specialty: Ear, Nose, Throat.

Browse the FDA 510(k) cleared devices submitted by Audina Hearing Instrument Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Audina Hearing Instrument

8 devices
1-8 of 8
Cleared Jan 17, 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816 · ESD
Ear, Nose, Throat · 49d
Cleared Sep 12, 1995
HEARING AID (ALL-IN-THE-EAR)
K953960 · ESD
Ear, Nose, Throat · 21d
Cleared Jun 17, 1994
AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
K942236 · LRB
Ear, Nose, Throat · 39d
Cleared Apr 04, 1994
BEHIND THE EAR HEARING AID
K936190 · ESD
Ear, Nose, Throat · 98d
Cleared Mar 18, 1993
BEHIND-THE-EAR HEARING AID
K930271 · ESD
Ear, Nose, Throat · 58d
Cleared Apr 18, 1990
MODEL AUDINA ITE HEATING AID
K897024 · ESD
Ear, Nose, Throat · 120d
Cleared Mar 16, 1990
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
K897023 · LRB
Ear, Nose, Throat · 87d
Cleared Apr 09, 1982
AUDICRAFT VIP HEARING AID
K820833 · ESD
Ear, Nose, Throat · 14d
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