Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GetingeLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Pulsion Medical Systems SE with 4 510(k) clearances. The most recent is a 510(k) clearance dated Apr 30, 2020: PulsioFlex Monitoring System with ProAQT Sensor.
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.
| Apr 30, 2020 | PulsioFlex Monitoring System with ProAQT SensorK192169 · DXG | 510(k) clearances |
| Feb 21, 2018 | PiCCO CatheterK171620 · KRB | 510(k) clearances |
| Jan 18, 2018 | PulsioFlex Monitoring SystemK172259 · DXG | 510(k) clearances |
| Aug 2, 2012 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULEK122121 · DXG | 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
