Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled 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 Medinol with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jan 25, 2018: Gallant PTCA Dilatation Catheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 25, 2018 | Gallant PTCA Dilatation CatheterK173581 · LOX | 510(k) clearances |
| Jan 19, 2017 | NC Gallant PTCA CatheterK162434 · LOX | 510(k) clearances |
| Feb 12, 2016 | X-Suit NIR Biliary Metallic StentK150487 · FGE | 510(k) clearances |
| Jan 9, 2009 | MEDINOL X-SUIT NIR BILIARY METALLIC STENTK081956 · FGE | 510(k) clearances |
| Oct 30, 2000 | NIR BILIARY STENTK002130 · FGE | 510(k) clearances |
| Nov 13, 1998 | NIR BILIARY STENTK973171 · FGE | 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
