8 results
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25ms
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Sources: EU EUDAMED, US FDA
SIMMONS CITRATE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
LA500 BLUE LIGHT
FDA 510(k)
FDA Class 2
·Dental
SHASER V-MINI 2 HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
TAXUS¿ LIBERTÉ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 15, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 9, 2010
Ingenia CX 3.0T-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 Number: 78127 (OUS)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·September 1, 2021
Ingenia 3.0T CX-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 Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021