Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Starkey Laboratories with 61 510(k) clearances. The most recent is a 510(k) clearance dated Jun 19, 2020: Multiflex Tinnitus Technology.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 19, 2020 | Multiflex Tinnitus TechnologyK201370 · KLW | 510(k) clearances |
| Oct 31, 2012 | MULTIFLEX TINNITUS TECHNOLOGYK122876 · KLW | 510(k) clearances |
| Sep 17, 2003 | CRESCENT TINNITUS RETAINING SOUND GENERATORK030180 · KLW | 510(k) clearances |
| May 2, 1997 | PRECISE IMPRESSION KITK970952 · ESD | 510(k) clearances |
| Feb 4, 1997 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITSK964245 · ESD | 510(k) clearances |
| Jan 10, 1997 | PORTAREM-3000, PFS-6000K964340 · EWO | 510(k) clearances |
| Dec 6, 1996 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKERK964216 · KLW | 510(k) clearances |
| Nov 27, 1996 | STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDSK964244 · ESD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
