Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Osprey Medical with 15 510(k) clearances. The most recent is a 510(k) clearance dated Oct 17, 2019: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ P….
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.
| Oct 17, 2019 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction SystemK190102 · DXT | 510(k) clearances |
| Dec 20, 2018 | DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction SystemK183267 · DXT | 510(k) clearances |
| Oct 25, 2018 | DyeVert PLUS EZ Contrast Reduction SystemK181936 · DXT | 510(k) clearances |
| Jul 7, 2017 | Smart SyringeK171698 · DXT | 510(k) clearances |
| May 26, 2017 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemK171217 · DXT | 510(k) clearances |
| Mar 8, 2017 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemK163054 · DXT | 510(k) clearances |
| Aug 3, 2016 | DyeVert NG Contrast Modulation SystemK161505 · DXT | 510(k) clearances |
| Feb 4, 2016 | DyeVert Contrast Modulation SystemK153141 · DXT | 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
