Medical Device Manufacturer · US , Danvers , MA

Abiomed, Inc. - FDA 510(k) Cleared Devices

19 submissions · 17 cleared · Since 1989

Total

Cleared

Denied

Abiomed, Inc. develops innovative cardiovascular devices focused on native heart recovery. Founded in 1981, the company specializes in percutaneous heart pump technology and related support systems. Now part of Johnson & Johnson, Abiomed operates with a manufacturing facility in Danvers, Massachusetts.

Abiomed has received 17 FDA 510(k) clearances from 19 total submissions since 1989. Cardiovascular devices represent 84% of the company's regulatory portfolio. The company remains active, with the latest clearance in 2025, demonstrating continued innovation and market presence.

The company's product portfolio includes the Impella® heart pump family, introducer kits, sheaths, and occlusion systems. Recent cleared devices span percutaneous support technologies and accessory components designed for hemodynamic support during high-risk procedures. Abiomed has treated over 350,000 patients globally with its technologies.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.

FDA 510(k) Regulatory Record - Abiomed, Inc.

19 devices

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