Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list ESI, Inc. with 3 drug applications and 3 510(k) clearances. The most recent is a 510(k) clearance dated Dec 5, 2008: PRAGER SHELL.
| Dec 5, 2008 | PRAGER SHELLK082893 · ITX | 510(k) clearances |
| Feb 21, 2008 | CLEARSCANK080119 · ITX | 510(k) clearances |
| Dec 29, 1981 | AFTERLOADING GYNECOLOGICAL APPLICATORK813230 · IWJ | 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
