Audina Hearing Instrument

FDA Regulatory Profile

Audina Hearing Instrument appears in FDA public data with 0 recalls, 8 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 17, 1997.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARJanuary 17, 1997
K953960HEARING AID (ALL-IN-THE-EAR)September 12, 1995
K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)June 17, 1994
K936190BEHIND THE EAR HEARING AIDApril 4, 1994
K930271BEHIND-THE-EAR HEARING AIDMarch 18, 1993
K897024MODEL AUDINA ITE HEATING AIDApril 18, 1990
K897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AIDMarch 16, 1990
K820833AUDICRAFT VIP HEARING AIDApril 9, 1982