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Biosense Webster, Inc.

18 FDA actions

CARTO™ 3 EP Navigation System V8.4

Biosense Webster, Inc.

CARTO™ 3 EP Navigation System V9.0 with PIU Plus

Biosense Webster, Inc.

CARTO™ 3 EP Navigation System V8.1

Biosense Webster, Inc.

VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based

Biosense Webster, Inc.

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

Biosense Webster, Inc.

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Biosense Webster, Inc.

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed

Biosense Webster, Inc.

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

Biosense Webster, Inc.

PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster®

Biosense Webster, Inc.

CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)

Biosense Webster, Inc.

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

Biosense Webster, Inc.

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

Biosense Webster, Inc.

OPTRELL™ Mapping Catheter with TRUEref™ Technology

Biosense Webster, Inc.

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

Biosense Webster, Inc.

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into

Biosense Webster, Inc.

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

Biosense Webster, Inc.

OPTRELL Mapping Catheter with TRUEref Technology

Biosense Webster, Inc.

LASSOSTAR NAV Circular Mapping Catheter

Biosense Webster, Inc.