BIOSENSE WEBSTER, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 4 510(k) filings: 0 Recalls: 2

Known Identifiers & Locations

FEI Numbers 3003113629, 3003248396, 3008203003, 3013300026, 3022451073
Owner Operator Numbers 9044811
Locations Covered Irvine, CA, US; JUAREZ Chihuahua, MX; Yokneam Northern, IL

Registered Establishments (4)

Registration # Establishment Name Location Establishment Type(s) Action
3008203003 Biosense Webster (Israel), Ltd. Yokneam Northern, IL Manufacture Medical Device View Details
3013300026 BIOSENSE WEBSTER, INC. Irvine, CA, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3022451073 BIOSENSE WEBSTER, INC. Irvine, CA, US Manufacture Medical Device View Details
9673241 BIOSENSE WEBSTER, INC. JUAREZ Chihuahua, MX Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0002-2016 Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added. 2015-09-10 Terminated View Details
Z-0003-2016 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. Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added. 2015-09-10 Terminated View Details

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