Pulsion Medical Systems AG - FDA 510(k) Cleared Devices

Pulsion Medical Systems AG, is now part of Getinge, a global medical technology company. The brand operates under Getinge's portfolio with a manufacturing facility in Concord, US. Pulsion specializes in advanced hemodynamic monitoring and cardiovascular diagnostic systems for critical care settings.

The company has received 5 FDA 510(k) clearances from 5 total submissions. All submissions focused on cardiovascular devices. Pulsion's regulatory history spans from 2002 to 2010, establishing a track record in thermodilution monitoring technology and optical sensing systems for hemodynamic assessment.

Notable cleared devices include the PICCO and PICCO2 monitoring systems, CEVOX optical modules, and Pulsiocath thermodilution catheters. These products represent core technologies for continuous cardiac output monitoring and tissue oxygenation assessment in intensive care environments.

This company profile reflects historical FDA 510(k) regulatory records. Explore device names, product codes, and clearance dates in the database for complete submission details.