Company ยท US
Starkey Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2020. Name variants (Inc, Corp, punctuation) are merged.
61510(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 19, 2020 | K201370 | Multiflex Tinnitus Technology Starkey Laboratories, Inc. | KLW |
| Oct 31, 2012 | K122876 | MULTIFLEX TINNITUS TECHNOLOGY Starkey Laboratories | KLW |
| Sep 17, 2003 | K030180 | CRESCENT TINNITUS RETAINING SOUND GENERATOR Starkey Laboratories, Inc. | KLW |
| May 2, 1997 | K970952 | PRECISE IMPRESSION KIT Starkey Laboratories, Inc. | ESD |
| Feb 4, 1997 | K964245 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS Starkey Laboratories, Inc. | ESD |
| Jan 10, 1997 | K964340 | PORTAREM-3000, PFS-6000 Starkey Laboratories, Inc. | EWO |
| Dec 6, 1996 | K964216 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Nov 27, 1996 | K964244 | STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS Starkey Laboratories, Inc. | ESD |
| Nov 27, 1996 | K964214 | STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS Starkey Laboratories, Inc. | ESD |
| Nov 26, 1996 | K963995 | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Nov 26, 1996 | K963838 | STARKEY TM AIR CONDUCTION TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Sep 27, 1996 | K963519 | EUROLINE A-675 SERIS Starkey Laboratories, Inc. | ESD |
| Mar 1, 1996 | K960494 | EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS Starkey Laboratories, Inc. | ESD |
| Oct 21, 1994 | K943460 | PORTAREM 2000 Starkey Laboratories, Inc. | ETW |
| Oct 21, 1994 | K943459 | DESKREM-1000 Starkey Laboratories, Inc. | ETW |
| Oct 20, 1994 | K943687 | FEDELITY F495, VIENNATONE ALPP II Starkey Laboratories, Inc. | ESD |
| Aug 17, 1994 | K943682 | SM-VEGA, SM-PC, SM-AGC, SM-AGC-H Starkey Laboratories, Inc. | ESD |
| Aug 9, 1994 | K940667 | STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID Starkey Laboratories, Inc. | ESD |
| Jul 5, 1994 | K942594 | STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID Starkey Laboratories, Inc. | ESD |
| Jun 24, 1994 | K942036 | EUROSTAR SUPER, EUROSTAR VFC Starkey Laboratories, Inc. | ESD |
| May 13, 1994 | K932269 | PRO-CONNECT Starkey Laboratories, Inc. | ESD |
| May 10, 1994 | K935701 | VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 Starkey Laboratories, Inc. | LXB |
| May 4, 1994 | K941636 | MINI PAK Starkey Laboratories, Inc. | ESD |
| May 4, 1994 | K941635 | INTRA S, INTRA SH Starkey Laboratories, Inc. | ESD |
| May 4, 1994 | K940978 | STARKEY EUROLINE A SERIES Starkey Laboratories, Inc. | ESD |
| Nov 29, 1993 | K934417 | OMNI 2000 SERIES ITC HEARING AID Starkey Laboratories, Inc. | ESD |
| Nov 29, 1993 | K934416 | OMNI 2000 SERIES ITE HEARING AID Starkey Laboratories, Inc. | ESD |
| Oct 7, 1993 | K933989 | RESOLUTION ITC HEARING AID Starkey Laboratories, Inc. | ESD |
| Oct 7, 1993 | K933988 | BOSCH EUROSTAR Starkey Laboratories, Inc. | ESD |
| Oct 7, 1993 | K933407 | STARKEY TYMPANETTE HEARING AID Starkey Laboratories, Inc. | ESD |
| Jul 27, 1993 | K933113 | STARKEY TRILOGY II PROGRAMMABLE HEARING AID Starkey Laboratories, Inc. | ESD |
| Mar 18, 1993 | K930853 | INTRA V AND SECRET EAR III Starkey Laboratories, Inc. | ESD |
| Mar 18, 1993 | K930805 | CE-9 IN-THE-EAR HEARING AID Starkey Laboratories, Inc. | ESD |
| Sep 4, 1992 | K922752 | STARKEY LABORATORIES OTOSCOPE Starkey Laboratories, Inc. | ERA |
| Aug 26, 1992 | K923784 | STARKEY SM SERIES BTE HEARING AIDS Starkey Laboratories, Inc. | ESD |
| May 7, 1991 | K911579 | STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS Starkey Laboratories, Inc. | ESD |
| Dec 21, 1990 | K903145 | HEARSET TELEPHONE HEARING SYSTEM Starkey Laboratories, Inc. | ESD |
| Aug 9, 1990 | K901833 | CE-8 CUSTOM IN-THE-EAR HEARING AIDS Starkey Laboratories, Inc. | ESD |
| Aug 6, 1990 | K902068 | HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER Starkey Laboratories, Inc. | EWO |
| Jul 20, 1990 | K901860 | INTRA III AND INTRA IV HEARING AIDS Starkey Laboratories, Inc. | ESD |
| Apr 11, 1988 | K880969 | STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES Starkey Laboratories, Inc. | ESD |
| Mar 18, 1988 | K880335 | INTRA II SECRET EAR HEARING AIDS ISE Starkey Laboratories, Inc. | ESD |
| Mar 18, 1988 | K880334 | CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 Starkey Laboratories, Inc. | ESD |
| Mar 18, 1988 | K880333 | CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7 Starkey Laboratories, Inc. | ESD |
| Feb 8, 1988 | K873031 | STARKEY MODEL P1 MODULE Starkey Laboratories, Inc. | LRB |
| Dec 3, 1984 | K844275 | STARKET MODEL HMS Starkey Laboratories, Inc. | ETW |
| Aug 3, 1982 | K821908 | STARKEY MODEL HAL-1 Starkey Laboratories, Inc. | ETW |
| Nov 12, 1980 | K802560 | TINNITUS RESEARCH AUDIOMETER Starkey Laboratories, Inc. | EWO |
| Nov 27, 1979 | K792214 | MODEL TM2-BEHIND-THE-EAR TINNITUS Starkey Laboratories, Inc. | BWF |
| Oct 26, 1979 | K791790 | MODEL TM5 BEHIND EAR TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||