4 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Ingenia 3.0T, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024