Biotronik, Inc. - FDA 510(k) Cleared Devices
84
Total
66
Cleared
0
Denied
Biotronik, Inc. has 66 FDA 510(k) cleared cardiovascular devices. Based in Lake Oswego, US.
Latest FDA clearance: Apr 2025. Active since 1994.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Biotronik, Inc.
84 devices
Cleared
Apr 04, 2025
Passeo-35 Xeo Peripheral Dilatation Catheter
Cardiovascular
25d
Cleared
Oct 25, 2024
Pantera Pro
Cardiovascular
29d
Cleared
Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
Cardiovascular
174d
Cleared
Jul 11, 2024
Oscar Peripheral Multifunctional Catheter system
Cardiovascular
27d
Cleared
May 19, 2023
BIOMONITOR IV
Cardiovascular
95d
Cleared
Feb 16, 2023
Passeo-35 Xeo Peripheral Dilatation Catheter
Cardiovascular
218d
Cleared
Jul 27, 2022
BIOMONITOR IIIm, BIOMONITOR III
Cardiovascular
30d
Cleared
Jul 19, 2022
Selectra Lead Implantation System
Cardiovascular
8d
Cleared
Jul 06, 2022
Oscar Peripheral Multifunctional Catheter system
Cardiovascular
195d
Cleared
Sep 02, 2021
MultiCath, AcQRate Dx Fixed Curve Catheter
Cardiovascular
458d
Cleared
Dec 08, 2020
Biomonitor III, Biomonitor IIIm
Cardiovascular
155d
Cleared
Oct 16, 2020
Selectra 3D Outer Guiding Catheters
Cardiovascular
305d
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