Fresenius Kabi - FDA 510(k) Cleared Devices

Fresenius Kabi, is a global healthcare company specializing in pharmaceutical, nutritional, and medical technology solutions. The company operates with a manufacturing facility in Bad Hersfeld, Germany, and maintains a worldwide presence across multiple regions.

Fresenius Kabi has received 2 FDA 510(k) clearances from 2 total submissions. The company's regulatory focus centers on General Hospital devices, with clearances granted in 2023. This represents a historical record of FDA submissions in the medical device space.

The company's cleared devices include intravenous administration sets and infusion therapy products designed for hospital use. These solutions support patient care in clinical settings through reliable delivery systems.

Explore the complete list of device names, product codes, and clearance dates in the database to learn more about Fresenius Kabi's regulatory history and product portfolio.

Regulatory submissions have been managed by Fresenius Kabi, LLC, USA and Fresenius Kabi USA,Llc.