4,188 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
FDA classification
FDA Class 1
·Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt