Starkey Laboratories, Inc.
Medical device manufacturer in Eden Prairie, MN.
61510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | 06/19/2020SE |
| K122876 | Multiflex Tinnitus TechnologyKLW · Traditional | 10/31/2012SE |
| K030180 | Crescent Tinnitus Retaining Sound GeneratorKLW · Traditional | 09/17/2003SE |
| K970952 | Precise Impression KitESD · Traditional | 05/02/1997SE |
| K964245 | Precise, Tynmpanette, and Xacto Impression KitsESD · Traditional | 02/04/1997SE |
| K964340 | PORTAREM-3000, PFS-6000EWO · Traditional | 01/10/1997SE |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerKLW · Traditional | 12/06/1996SE |
| K964244 | Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K964214 | Starkey A-13 Sequel Programmable, A-13 K-Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K963995 | Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus MaskerKLW · Traditional | 11/26/1996SE |
| K963838 | Starkey TM Air Conduction Tinnitus MaskerKLW · Traditional | 11/26/1996SE |
| K963519 | Euroline A-675 SerisESD · Traditional | 09/27/1996SE |
| K960494 | Euroline A312 Series of Behind the Ear Air Conduction Hearing AidsESD · Traditional | 03/01/1996SE |
| K943460 | Portarem 2000ETW · Traditional | 10/21/1994SE |
| K943459 | DESKREM-1000ETW · Traditional | 10/21/1994SE |
| K943687 | Fedelity F495, Viennatone Alpp IIESD · Traditional | 10/20/1994SE |
| K943682 | Sm-Vega, Sm-Pc, Sm-Agc, Sm-Agc-HESD · Traditional | 08/17/1994SE |
| K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidESD · Traditional | 08/09/1994SE |
| K942594 | Star 42 PP SP Star 42 Digitally Programmable Hearing AidESD · Traditional | 07/05/1994SE |
| K942036 | Eurostar Super, Eurostar VFCESD · Traditional | 06/24/1994SE |
| K932269 | Pro-ConnectESD · Traditional | 05/13/1994SE |
| K935701 | Viennatone an, Viennatone AS Fidelity F228, Fidelity F229LXB · Traditional | 05/10/1994SE |
| K941636 | Mini PakESD · Traditional | 05/04/1994SE |
| K941635 | Intra S, Intra SHESD · Traditional | 05/04/1994SE |
| K940978 | Starkey Euroline a SeriesESD · Traditional | 05/04/1994SE |
| K934417 | Omni 2000 Series Itc Hearing AidESD · Traditional | 11/29/1993SE |
| K934416 | Omni 2000 Series Ite Hearing AidESD · Traditional | 11/29/1993SE |
| K933989 | Resolution Itc Hearing AidESD · Traditional | 10/07/1993SE |
| K933988 | Bosch EurostarESD · Traditional | 10/07/1993SE |
| K933407 | Starkey Tympanette Hearing AidESD · Traditional | 10/07/1993SE |
| K933113 | Starkey Trilogy II Programmable Hearing AidESD · Traditional | 07/27/1993SE |
| K930853 | Intra V and Secret Ear IIIESD · Traditional | 03/18/1993SE |
| K930805 | CE-9 In-The-Ear Hearing AidESD · Traditional | 03/18/1993SE |
| K922752 | Starkey Laboratories OtoscopeERA · Traditional | 09/04/1992SE |
| K923784 | Starkey SM Series Bte Hearing AidsESD · Traditional | 08/26/1992SE |
| K911579 | Starkey Trilogy Program Hear Aid Cc/Ce ModelsESD · Traditional | 05/07/1991SE |
| K903145 | Hearset Telephone Hearing SystemESD · Traditional | 12/21/1990SE |
| K901833 | CE-8 Custom In-The-Ear Hearing AidsESD · Traditional | 08/09/1990SE |
| K902068 | Hearing Ambassador-Hear Pen Screening AudiometerEWO · Traditional | 08/06/1990SE |
| K901860 | Intra III and Intra IV Hearing AidsESD · Traditional | 07/20/1990SE |
| K880969 | Star 22,33,66 Series & Starkey H. and SM SeriesESD · Traditional | 04/11/1988SE |
| K880335 | Intra II Secret Ear Hearing Aids IseESD · Traditional | 03/18/1988SE |
| K880334 | Custom Canal Hearing Aids Intra II CC-5, 6 & 7ESD · Traditional | 03/18/1988SE |
| K880333 | Custom I.T.E. Hearing Aids CE-5, CE-6, CE-7ESD · Traditional | 03/18/1988SE |
| K873031 | Starkey Model P1 ModuleLRB · Traditional | 02/08/1988SE |
| K844275 | Starket Model HMSETW · Traditional | 12/03/1984SE |
| K821908 | Starkey Model HAL-1ETW · Traditional | 08/03/1982SE |
| K802560 | Tinnitus Research AudiometerEWO · Traditional | 11/12/1980SE |
| K792214 | Model TM2-BEHIND-THE-EAR TinnitusBWF · Traditional | 11/27/1979SE |
| K791790 | Model TM5 Behind Ear Tinnitus MaskerKLW · Traditional | 10/26/1979SE |
| K791142 | Hearing Aid, Model MA-1KLW · Traditional | 09/28/1979SE |
| K791203 | Model SE-1 Eyeglass Hearing AidESD · Traditional | 08/10/1979SE |
| K791071 | Model MA3 Behind-The-Ear Masker/HearingKLW · Traditional | 07/03/1979SE |
| K790745 | _Model WC-1 Behind-The-Ear Hearing AidESD · Traditional | 05/01/1979SE |
| K790651 | Model WC-3 Hearing AidESD · Traditional | 04/10/1979SE |
| K790482 | Model 4107-2S, Hearing AidESD · Traditional | 04/03/1979SE |
| K790481 | Model FS1KHL · Traditional | 04/03/1979SE |
| K781798 | Tinnitus MaskerKLW · Traditional | 11/03/1978SE |
| K780309 | In-The-Ear Hearing Aid, Model CE-3ESD · Traditional | 02/28/1978SE |
| K772101 | Hearing Aid-Model PE-1ESD · Traditional | 11/21/1977SE |
| K772100 | Hearing Aid-Model CE-2ESD · Traditional | 11/21/1977SE |