Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list OrbusNeich Medical, Inc. with 14 510(k) clearances. The most recent is a 510(k) clearance dated Sep 16, 2026: JADE SCORE PTA Scoring 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.
| Sep 16, 2026 | JADE SCORE PTA Scoring Balloon Dilatation CatheterK261778 · PNO | 510(k) clearances |
| Apr 10, 2026 | Teleport Glide MicrocatheterK253361 · DQY | 510(k) clearances |
| Jan 7, 2025 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)K242588 · DQY | 510(k) clearances |
| Aug 16, 2024 | Sapphire NC ULTRA Coronary Dilatation CatheterK233499 · LOX | 510(k) clearances |
| Aug 15, 2024 | Sapphire ULTRA Coronary Dilatation CatheterK233505 · LOX | 510(k) clearances |
| Jun 11, 2024 | JADE PLUS PTA Balloon Dilatation CatheterK241025 · LIT | 510(k) clearances |
| Jan 7, 2024 | Teleport XT MicrocatheterK231608 · DQY | 510(k) clearances |
| Oct 14, 2021 | Sapphire NC 24K211807 · LOX | 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
