Medical Device Manufacturer · US , Lake Oswego , OR

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

85 submissions · 67 cleared · Since 1994

Total

Cleared

Denied

Biotronik, Inc. designs and manufactures advanced active implants for cardiac rhythm management, monitoring, and electrophysiology. The company operates with a manufacturing facility in Lake Oswego, Oregon, and serves patients globally through innovative cardiovascular solutions.

Biotronik has received 67 FDA 510(k) clearances from 85 total submissions since its first clearance in 1994. The company specializes exclusively in cardiovascular devices, including pacing systems, implantable cardioverter defibrillators, cardiac resynchronization therapies, and electrophysiology catheters. A recent clearance in 2026 confirms active regulatory engagement.

Notable cleared devices include the BIOMONITOR IV implantable cardiac monitor, Passeo-35 Xeo peripheral dilatation catheter, Pantera Pro coronary stent, and Selectra lead delivery systems. The company also offers digital health solutions through its CardioSphere platform, supporting remote patient monitoring and data management for cardiac care.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.

1 device has linked clinical trial registered on ClinicalTrials.gov.

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

85 devices

1-12 of 85