Medical device makerLabelled 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 15, 2026, FDA's public records list Infinium Medical with 7 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 14, 2026: Vital Signs Monitor (CLEO2).
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.
| Aug 14, 2026 | Vital Signs Monitor (CLEO2)K260438 · MWI | 510(k) clearances |
| May 31, 2019 | CLEO Patient Monitor /Tranquility VS Patient MonitorClass II · The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperatu | Device recalls |
| Feb 6, 2015 | CLEO PATIENT MONITORK142244 · MWI | 510(k) clearances |
| Feb 21, 2014 | OMNI PATENT MONITORSK132229 · MWI | 510(k) clearances |
| Sep 8, 2011 | OMNI PATIENT MONITORK112329 · MWI | 510(k) clearances |
| Jun 2, 2011 | OMNI II PATIENT MONITORK103737 · MWI | 510(k) clearances |
| Nov 23, 2010 | OMNI EXPRESSK103268 · MWI | 510(k) clearances |
| Aug 11, 2010 | OMNI III PATIENT MONITORK101052 · MWI | 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
