77 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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GE Healthcare Vivid S60, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S70, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S70N, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S60N, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
SMV DSI, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
MAXXUS, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV BodyTrack, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV DSX New Line, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
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
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
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 27, 2022
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