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 14, 2026, FDA's public records list Elana with 2 device recalls. The most recent is a device recall dated Nov 9, 2016: Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xe….
| Nov 9, 2016 | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for cClass II · Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to pot | Device recalls |
| Feb 14, 2013 | Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA techniqueClass II · Distribution of an unapproved device into interstate commerce. | Device recalls |
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
