Biosense Webster, Inc. - FDA 510(k) Cleared Devices
73
Total
73
Cleared
0
Denied
FDA 510(k) cleared devices by Biosense Webster, Inc. Cardiovascular ✕
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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