Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled 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 15, 2026, FDA's public records list Creagh Medical with 7 510(k) clearances. The most recent is a 510(k) clearance dated Nov 15, 2024: 018 Hydrophilic Coated OTW PTA Balloon 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.
| Nov 15, 2024 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterK242419 · LIT | 510(k) clearances |
| Mar 22, 2023 | Arise™ UHP Dilatation CatheterK230191 · LIT | 510(k) clearances |
| May 14, 2020 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CatheterK200700 · LIT | 510(k) clearances |
| Apr 19, 2018 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterK180007 · LIT | 510(k) clearances |
| Sep 8, 2017 | 014 Hydrophilic Coated PTA Balloon Dilatation CatheterK171251 · LIT | 510(k) clearances |
| Dec 20, 2011 | ELM PTA BALLON DILATATION CATHETERK113468 · LIT | 510(k) clearances |
| Dec 10, 2010 | WILLOW/ELM PTA BALLOON DILATATION CATHETERK102645 · LIT | 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
