Data / Medical devices / Israel / Biosense Webster (Israel), Ltd.
Biosense Webster (Israel), Ltd.: FDA-registered device maker in Yokneam Northern, Israel, 15 510(k) clearances
Biosense Webster (Israel), Ltd. is registered with the FDA (registration 3008203003) in Yokneam Northern, Israel. It lists 2 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 20, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008203003
- Address
- 4 Hatnufa Street, Yokneam Northern, Israel, 2066717
- Owner or operator
- BIOSENSE WEBSTER, INC. (9044811)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 26, 2007
- Registered through
- 2027
- Brand names listed
- CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES, CARTO 3 EP Navigation System & CARTO 3 External Reference Patches, CARTO 3 EP Navigation System V8.4, CARTO 3 EP Navigation System Version 7.2, CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM), CARTO 3 EP Navigation System with CARTOSOUND 4D v7/4, CARTO 3 EP Navigation System with Signal Processing Unit, CARTO 3 EP Navigation System, Version 6 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2026 | K252972 | CARTO 3 EP Navigation System V8.4 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 18, 2026 | K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 22, 2025 | K252302 | CARTO 3 EP Navigation System V8.1 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 7, 2023 | K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 17, 2022 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 29, 2021 | K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 25, 2020 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 20, 2019 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 24, 2018 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 14, 2018 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 1, 2018 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 25, 2017 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 13, 2009 | K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 19, 2007 | K072202 | CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 22, 2020 | 85910 | Class II | Terminated | CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the | Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Ear, Nose, And Throat Stereotaxic Instrument
Updated February 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.