Biosense Webster, Inc. - FDA 510(k) Cleared Devices
73
Total
73
Cleared
0
Denied
Biosense Webster, Inc. has 73 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.
Latest FDA clearance: Feb 2026. Active since 1999.
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 Biosense Webster, Inc.
73 devices
Cleared
Feb 20, 2026
CARTO™ 3 EP Navigation System V8.4
Cardiovascular
156d
Cleared
Jan 18, 2026
CARTO™ 3 EP Navigation System V9.0 with PIU Plus
Cardiovascular
31d
Cleared
Aug 22, 2025
CARTO™ 3 EP Navigation System V8.1
Cardiovascular
29d
Cleared
Jun 28, 2024
NUVISION™ Ultrasound Catheter
Cardiovascular
28d
Cleared
Jun 12, 2024
SOUNDSTAR™ CRYSTAL Ultrasound Catheter
Cardiovascular
156d
Cleared
Sep 07, 2023
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Cardiovascular
133d
Cleared
Jul 10, 2023
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter,...
Cardiovascular
66d
Cleared
Jul 10, 2023
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S,...
Cardiovascular
55d
Cleared
Mar 02, 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
Cardiovascular
30d
Cleared
Feb 16, 2023
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
Cardiovascular
65d
Cleared
Feb 16, 2023
NUVISION™ NAV Ultrasound Catheter
Cardiovascular
63d
Cleared
Aug 17, 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
Cardiovascular
124d
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