30 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
FDA Enforcement
Class II
·Terminated·LivaNova USA·May 30, 2018
Enterprise 1.5T, Model Number: 781145;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T R11, Model Number: 781170;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera CV, Model Number: 781107;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 0.5T Standard, Model Number: 781101;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Power/Pulsar, Model Number: 781105;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T, Model Numbers: 781195 and 781295;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
SmartPath to dStream for 1.5T, Model Number: 782146;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Master/Nova, Model Number: 781106;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.0T Power/Pulsar, Model Number: 781103;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
SmartPath to dStream for 3.0T, Model Number: 782145;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Omni/Stellar, Model Number: 781104;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 3.0T Quasar Dual, Model Number: 781150;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.0T Omni/Stellar, Model Number: 781102;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024