47 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS, ISRAEL LTD.·October 11, 2023
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025
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 electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
FDA Enforcement
Class II
·Terminated·Biosense Webster (israel), Ltd.·September 2, 2020
Mazor X robotic guidance system REF: TPL0059
FDA Enforcement
Class II
·Ongoing·Mazor Robotics Ltd·January 28, 2026
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025