Medical device makerLabelled 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 15, 2026, FDA's public records list Entific Medical Systems with 5 510(k) clearances. The most recent is a 510(k) clearance dated Aug 26, 2004: BAHA DIVINO.
| Aug 26, 2004 | BAHA DIVINOK042017 · LXB | 510(k) clearances |
| Aug 30, 2002 | BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)K021837 · LXB | 510(k) clearances |
| Jul 23, 2001 | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.K011438 · LXB | 510(k) clearances |
| Oct 17, 2000 | HEADBAND FOR BAHAK002913 · LXB | 510(k) clearances |
| Nov 24, 1999 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IIK992872 · LXB | 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
