34 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022