7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeaSpine Regatta Lateral System
FDA 510(k)
FDA Class 2
·Orthopedic
SYNGO.VIA WEB VIEWER
FDA 510(k)
FDA Class 2
·Radiology
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
FDA 510(k)
FDA Class 2
·Radiology
HT50 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·October 17, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·June 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021