BEUDAMED
    32 results · 45ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·September 21, 2016

    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016

    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.

    FDA Enforcement
    Class I ·Ongoing·Biosense Webster, Inc.·March 12, 2025

    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·May 11, 2016

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

    FDA Enforcement
    Class II ·Ongoing·Biosense Webster, Inc.·April 12, 2023

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

    FDA Enforcement
    Class II ·Ongoing·Biosense Webster, Inc.·April 12, 2023

    20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·April 3, 2013

    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·June 3, 2015

    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·May 6, 2015

    CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·February 26, 2014

    CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO¿ XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·September 19, 2012

    Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·May 11, 2016

    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·July 10, 2013

    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·March 19, 2014

    SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·October 7, 2015