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., part of AbbottLabelled 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 13, 2026, FDA's public records list Endocardial Solutions with 8 510(k) clearances. The most recent is a 510(k) clearance dated Oct 15, 2004: ENSITE SYSTEM, MODEL EE3000.
| Oct 15, 2004 | ENSITE SYSTEM, MODEL EE3000K042493 · DQK | 510(k) clearances |
| Oct 30, 2003 | ENSITE SYSTEMK033211 · DQK | 510(k) clearances |
| Apr 22, 2003 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000K030129 · DQK | 510(k) clearances |
| Sep 28, 2001 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000K012926 · MTD | 510(k) clearances |
| Jun 7, 2000 | ENSITE 3000 SYSTEM, MODEL EE3000K001437 · DQK | 510(k) clearances |
| Jan 5, 2000 | ENSTYLET MODELS EC0010, EC0020K993376 · DRB | 510(k) clearances |
| Dec 2, 1999 | ENSITE 3000 SYSTEMK992479 · DQK | 510(k) clearances |
| Apr 21, 1999 | ENSITE 3000 SYSTEMK983456 · MTD | 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
