9 results
·
49ms
·
Sources: EU EUDAMED, US FDA
VERO BIOTECH
FDA Adverse Event
Injury
·VERO BIOTECH, LLC·Product code MRN·June 22, 2022
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 Recall
Open, Classified
·Vero Biotech, LLC·Product code MRN·November 17, 2023
GENOSYL DS (Delivery System) console, for use as a vasodilator.
FDA Recall
Completed
·Vero Biotech, LLC·Product code MRN·September 9, 2021
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
FDA Recall
Terminated
·Vero Biotech, LLC·Product code MRN·May 19, 2021
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
Y. Sung Handelsvertretung
Authorized representative
🇩🇪 Germany·80 Manufacturers
Kingsmead Service B.V.
Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices