Company ยท US
Oticon Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1997. Name variants (Inc, Corp, punctuation) are merged.
66510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 1997 | K973886 | OTICON DIGISOUND COMPACT Oticon, Inc. | ESD |
| Nov 4, 1997 | K973885 | OTICON DIGISOUND ITE Oticon, Inc. | ESD |
| Dec 12, 1996 | K964683 | DIGIFOCUS ITE Oticon, Inc. | ESD |
| Nov 27, 1996 | K963788 | PRIMOFOCUS COMPACT Oticon Corp. | ESD |
| May 7, 1996 | K961059 | DIGIFOCUS COMPACT Oticon, Inc. | ESD |
| Mar 7, 1996 | K960284 | OTICON /PRIMOFOCUS (PF) Oticon, Inc. | ESD |
| Nov 13, 1995 | K954794 | OTICON Oticon, Inc. | ESD |
| Feb 27, 1995 | K950381 | OTICON/LOGIC Oticon, Inc. | ESD |
| Jan 30, 1995 | K946045 | OTICON Oticon, Inc. | ESD |
| Aug 23, 1993 | K933307 | MULTIFOCUS COMPACT BTE HEARING AID Oticon, Inc. | ESD |
| Aug 5, 1993 | K932670 | OTICON MF Oticon Corp. | ESD |
| Aug 6, 1992 | K923491 | BTE HEARING AID PERSONIC 425 Oticon Corp. | ESD |
| Aug 6, 1992 | K923490 | BTE HEARING AID PERSONIC 410 Oticon Corp. | ESD |
| Aug 6, 1992 | K923388 | BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER Oticon Corp. | ESD |
| Jul 6, 1992 | K905555 | A-ZILICONE Oticon Corp. | ESD |
| Nov 1, 1990 | K904673 | OTICAON BTE MODEL E34P Oticon Corp. | ESD |
| Jul 9, 1990 | K902559 | CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P Oticon Corp. | ESD |
| Jun 14, 1990 | K902353 | CUSTOM ITE HEARING AID MODELS F AND L Oticon Corp. | ESD |
| Jun 14, 1990 | K902352 | CUSTOM ITE HEARING AID MODEL: H Oticon Corp. | ESD |
| Jun 14, 1990 | K902351 | CUSTOM ITE HEARING AID MODELS C AND M Oticon Corp. | ESD |
| Apr 10, 1990 | K901292 | OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44 Oticon Corp. | ESD |
| Oct 11, 1989 | K895140 | CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 Oticon Corp. | ESD |
| Aug 15, 1989 | K893528 | OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID Oticon Corp. | ESD |
| Mar 17, 1989 | K890703 | CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A Oticon Corp. | ESD |
| Mar 9, 1989 | K890704 | BTE HEARING AID OTICON MODEL: E42P Oticon Corp. | ESD |
| Jan 19, 1988 | K874651 | OTICON HEARING AID MODEL I52 Oticon Corp. | ESD |
| Dec 29, 1987 | K874380 | BTE HEARING AID OTICON MODEL E38P Oticon Corp. | ESD |
| Dec 23, 1987 | K874381 | BTE HEARING AID OTICON MODEL E39PL Oticon Corp. | ESD |
| Dec 10, 1987 | K874744 | OTICON MODEL I50 IN-THE-EAR HEARING AID Oticon Corp. | ESD |
| Jul 31, 1987 | K872372 | BEHIND-THE-EAR HEARING AID OTICON E40 Oticon Corp. | ESD |
| Jun 8, 1987 | K872017 | BTE HEARING AID OTICON MODEL E30P Oticon Corp. | ESD |
| Oct 15, 1986 | K862981 | OTICON I31 INITIALES HEARING AID Oticon Corp. | ESD |
| Aug 26, 1986 | K862980 | OTICON I31 CITE HEARING AID Oticon Corp. | ESD |
| Aug 7, 1986 | K862623 | I81 INITIALES Oticon Corp. | ESD |
| Aug 1, 1986 | K862624 | I81 CITE Oticon Corp. | ERA |
| Aug 1, 1986 | K862622 | I22 CITE Oticon Corp. | ESD |
| Aug 1, 1986 | K862621 | I22 INITIALES Oticon Corp. | ERA |
| Feb 20, 1986 | K854742 | OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE Oticon Corp. | ESD |
| May 29, 1985 | K851430 | EARETTE HEARING AID(BEHIND THE EAR OTICON E37F Oticon Corp. | ESD |
| May 29, 1985 | K851429 | EARETTE HEARING AID(BEHIND THE EAR OTICON E35F Oticon Corp. | ESD |
| Mar 25, 1985 | K850763 | EARETTE HEARING AID OTICON E32U Oticon Corp. | ESD |
| Mar 25, 1985 | K850762 | EARETTE HEARING AID OTICON MODEL E32S Oticon Corp. | ESD |
| Aug 23, 1984 | K842074 | EARETTE HEARING AID OTICON E30V Oticon Corp. | ESD |
| Aug 23, 1984 | K842073 | EARETTE HEARING AID OTICON E31V Oticon Corp. | ESD |
| Jun 27, 1984 | K841436 | OTICON E28A Oticon Corp. | ESD |
| Dec 8, 1983 | K833803 | OTICON, E26P Oticon Corp. | ESD |
| Aug 19, 1982 | K821987 | EARETTE HEARING AID OPTICON MODEL E28P Oticon Corp. | ESD |
| Jun 7, 1982 | K821325 | OTICON Oticon Corp. | ESD |
| May 5, 1981 | K810987 | EARETTE HEARING AID OTICON #E27F Oticon Corp. | ESD |
| May 5, 1981 | K810986 | EARETTE HEARING AID OTICON #E25F Oticon Corp. | ESD |
Newest 50 of 66.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||