Oticon, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
68
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K133308TINNITUS SOUNDSUPPORTMarch 18, 2014
K973886OTICON DIGISOUND COMPACTNovember 4, 1997
K973885OTICON DIGISOUND ITENovember 4, 1997
K964683DIGIFOCUS ITEDecember 12, 1996
K963788PRIMOFOCUS COMPACTNovember 27, 1996
K961059DIGIFOCUS COMPACTMay 7, 1996
K960284OTICON /PRIMOFOCUS (PF)March 7, 1996
K954794OTICONNovember 13, 1995
K951002AMENDMENTS TO MULTIFOCUSSeptember 18, 1995
K950381OTICON/LOGICFebruary 27, 1995
K946045OTICONJanuary 30, 1995
K933307MULTIFOCUS COMPACT BTE HEARING AIDAugust 23, 1993
K932670OTICON MFAugust 5, 1993
K923491BTE HEARING AID PERSONIC 425August 6, 1992
K923490BTE HEARING AID PERSONIC 410August 6, 1992
K923388BTE HEARING AID OTICON MODEL: MULTIFOCUS POWERAugust 6, 1992
K905555A-ZILICONEJuly 6, 1992
K904673OTICAON BTE MODEL E34PNovember 1, 1990
K902559CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: PJuly 9, 1990
K902353CUSTOM ITE HEARING AID MODELS F AND LJune 14, 1990