296 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·March 22, 2017
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Enforcement
Class II
·Terminated·General Electric Med Systems LLC·June 20, 2012
3mensio Workstation (Vascular Fenestrated) software
FDA Enforcement
Class II
·Ongoing·PIE Medical Imaging B.V.·August 20, 2025
Allia IGS 3 Pulse angiographic X-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 17, 2026
Allia IGS Pulse angiographic X-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 17, 2026
Allia Moveo angiographic X-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 17, 2026
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 24, 2026
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 24, 2026
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024
Allia IGS 5 Pulse angiographic X-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 17, 2026
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Allia IGS 7 Pulse angiographic X-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 17, 2026
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·May 20, 2026
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·April 1, 2026
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 17, 2025