3 results
·
47ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
FDA Enforcement
Class I
·Terminated·Vero Biotech, LLC·June 30, 2021
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
FDA Enforcement
Class II
·Ongoing·Vero Biotech, LLC·December 27, 2023
GENOSYL DS (Delivery System) console, for use as a vasodilator.
FDA Enforcement
Class I
·Completed·Vero Biotech, LLC·October 6, 2021