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 its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Intelligent Hearing Systems with 13 510(k) clearances. The most recent is a 510(k) clearance dated Sep 29, 2017: SmartEP.
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.
| Sep 29, 2017 | SmartEPK163326 · GWJ | 510(k) clearances |
| Jul 7, 2009 | SMARTSCREENER-PLUS2K090579 · GWJ | 510(k) clearances |
| Feb 28, 2008 | SMART COUPLER, MODEL M015401K073384 · GWJ | 510(k) clearances |
| Jul 18, 2007 | SMARTEP, MODEL M010000K070608 · GWJ | 510(k) clearances |
| Dec 11, 2006 | WICK ELECTRODE, MODEL M019260K063402 · GXY | 510(k) clearances |
| Jun 23, 2006 | SMART USBLITE, MODEL M011120K061443 · GWJ | 510(k) clearances |
| Aug 31, 2005 | OPTI-AMP DC-POWEREDK052060 · GWL | 510(k) clearances |
| Feb 20, 2004 | SMARTEP-ASSR, MODEL M811007K031051 · GWJ | 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
