Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-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 14, 2026, FDA's public records list Capsule Technologie with 9 510(k) clearances. The most recent is a 510(k) clearance dated Oct 19, 2021: Capsule Vitals Plus Patient Monitoring System.
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.
| Oct 19, 2021 | Capsule Vitals Plus Patient Monitoring SystemK210204 · MWI | 510(k) clearances |
| Jul 10, 2020 | SmartLinx Vitals Plus Patient Monitoring SystemK200856 · MWI | 510(k) clearances |
| Apr 17, 2019 | SmartLinx Vitals Plus Patient Monitoring SystemK183638 · MWI | 510(k) clearances |
| Aug 8, 2018 | SmartLinx Vitals Plus Patient Monitoring SystemK180734 · MWI | 510(k) clearances |
| Oct 24, 2017 | SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature ModuleK171751 · MWI | 510(k) clearances |
| Sep 17, 2015 | SmartLinx Vitals Plus Patient Monitoring SystemK151071 · MWI | 510(k) clearances |
| Aug 8, 2003 | DATACAPTORK032142 · MWI | 510(k) clearances |
| Feb 21, 2002 | MODIFICATION TO DATACAPTORK020197 · 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
