Biotech companyLabelled 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 14, 2026, FDA's public records list Vero Biotech with 3 device recalls, 2 drug applications and 1 complete response letter. The most recent is a device recall dated Nov 17, 2023: VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01;….
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 17, 2023 | VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalaClass II · Cassette did not meet an 1n-process flow criterion. | Device recalls |
| Sep 9, 2021 | GENOSYL DS (Delivery System) console, for use as a vasodilator.Class I · Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO | Device recalls |
| May 19, 2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860Class I · Reports received of NO measured below desired dose during transition between primary console and backup console since So | Device recalls |
| Jan 23, 2019 | Complete response letter, NDA 202860Approved | Complete response letters |
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
