Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of LivaNovaLabelled by claude-sonnet-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 Ela Medical, Inc. with 43 510(k) clearances. The most recent is a 510(k) clearance dated Oct 20, 2004: SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER.
| Oct 20, 2004 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK042002 · DQK | 510(k) clearances |
| Aug 22, 2003 | SPIDERVIEWK032466 · MWJ | 510(k) clearances |
| May 2, 2001 | SYNETECK002817 · DQK | 510(k) clearances |
| Apr 10, 2000 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK993448 · DTB | 510(k) clearances |
| Apr 4, 2000 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029 · DTB | 510(k) clearances |
| Nov 26, 1999 | SYNEFLASH & SYNEVIEWK990727 · DQK | 510(k) clearances |
| Jan 8, 1998 | STELA MODEL UJ45 PACING LEADSK972574 · DTB | 510(k) clearances |
| Aug 29, 1997 | OPUS S MODEL 4121 AND 4124 PACEMAKERSK970072 · DXY | 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
