35 results
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16ms
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Sources: EU EUDAMED, US FDA
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
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 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 1.5T SIGNA HDe 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 SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022