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., part of Cardinal HealthLabelled by claude-sonnet-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 Lexion Medical with 13 510(k) clearances and 1 warning letter. The most recent is a warning letter dated Jul 26, 2021: Warning letter: Cleaning validation, Marketing claims, 510(k) required.
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.
| Jul 26, 2021 | Warning letter: Cleaning validation, Marketing claims, 510(k) requiredCDRH | Warning letters |
| Aug 28, 2019 | AP50/30 Insufflator with Insuflow PortK191780 · HIF | 510(k) clearances |
| Nov 14, 2017 | AP 50/30 Insufflator with Insuflow PortK170799 · HIF | 510(k) clearances |
| Mar 5, 2014 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORTK140263 · HIF | 510(k) clearances |
| Sep 20, 2013 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULAK132203 · HIF | 510(k) clearances |
| Aug 22, 2013 | INSUFLOW SYNERGY XL PORTK132204 · HIF | 510(k) clearances |
| Jul 18, 2012 | INSUFLOW SYNERGY PORTK120640 · HIF | 510(k) clearances |
| Nov 10, 2011 | VESSEL GUARDIANK112357 · HIF | 510(k) clearances |
| Sep 27, 2010 | VESSEL GUARDIANK102136 · HIF | 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
