Company ยท US
Phonak, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2013. Name variants (Inc, Corp, punctuation) are merged.
39510(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 |
|---|---|---|---|
| Jun 27, 2013 | K130790 | LYRIC2 Phonak, LLC | ESD |
| Feb 11, 2013 | K123450 | PHONAK TINNITUS BALANCE Phonak, LLC | KLW |
| Aug 15, 1997 | K972106 | PHONAK NOVO FORTE E3 Phonak, Inc. | ESD |
| Aug 1, 1997 | K972105 | PHONAK EPICA Phonak, Inc. | ESD |
| Jul 30, 1997 | K972097 | PHONAK MICROZOOM P 2 Phonak, Inc. | ESD |
| Dec 4, 1996 | K964035 | PHONAK MICROLINK, PERSONAL FM RECEIVER Phonak, Inc. | ESD |
| May 29, 1996 | K961653 | PHONAK SONA P2 Phonak, Inc. | ESD |
| May 17, 1996 | K961622 | PHONAK PICONET2 P2 AZ Phonak, Inc. | ESD |
| Sep 18, 1995 | K953921 | PHONAK 9900 CIC Phonak, Inc. | ESD |
| Aug 23, 1995 | K945439 | PHONAK PICONET 232X-AZ HEARING INSTRUMENT Phonak, Inc. | ESD |
| Mar 21, 1995 | K950758 | DYNA 231X Phonak, Inc. | ESD |
| Jan 26, 1995 | K946294 | PHONAK SONO-FORTE 332X-AZ Phonak, Inc. | ESD |
| Jun 24, 1994 | K941768 | PHONAK MICROVOX RESONAL FM SYSTEM Phonak, Inc. | EPF |
| May 13, 1994 | K941734 | PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS Phonak, Inc. | ESD |
| Jan 26, 1994 | K935791 | PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Jul 27, 1993 | K932735 | PHONAK PICO-FORTE SC-D-2 Phonak, Inc. | ESD |
| Jul 27, 1993 | K932734 | PHONAK PICO-FORTE SC-2 Phonak, Inc. | ESD |
| Jul 8, 1993 | K932175 | PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT Phonak, Inc. | ESD |
| Feb 1, 1993 | K930145 | PHONAK PICONET 231-X Phonak, Inc. | ESD |
| Nov 4, 1992 | K924914 | PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Nov 4, 1992 | K924913 | PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR Phonak, Inc. | ESD |
| Nov 4, 1992 | K924911 | PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Nov 3, 1992 | K924912 | PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Sep 28, 1992 | K923743 | BTE WITH ACCESSORY ATTACHED Phonak, Inc. | ESD |
| Dec 30, 1991 | K915461 | PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES Phonak, Inc. | ESD |
| Sep 6, 1991 | K913503 | PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Sep 6, 1991 | K913502 | PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Jun 26, 1991 | K912571 | PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Jun 26, 1991 | K912570 | PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Apr 17, 1991 | K911211 | PHONAK 9100 SC-AF ITE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Apr 17, 1991 | K911210 | PHONAK 9800 SC-AF ITE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Apr 15, 1991 | K911209 | PHONAK 9300 SC-AF ITE HEARING INSTRUMENT Phonak, Inc. | ESD |
| Mar 8, 1991 | K910028 | POST AURICULAR HEARING AID MODEL PICO SC-H Phonak, Inc. | ESD |
| Feb 28, 1991 | K910018 | POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC Phonak, Inc. | ESD |
| Feb 28, 1991 | K910012 | PHONAK MODEL PICO C-S-H-T, BTE HEARING AID Phonak, Inc. | ESD |
| May 23, 1990 | K900831 | BTE PICO SCD, PICO SC Phonak, Inc. | ESD |
| May 23, 1990 | K900830 | BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4 Phonak, Inc. | ESD |
| May 23, 1990 | K900829 | BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC Phonak, Inc. | ESD |
| May 23, 1990 | K900675 | PHONAK ITE 8000, 7000, 6000 ITE HEARING AID Phonak, Inc. | ESD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||