7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIEMENS SONOLINE 4XX
FDA 510(k)
FDA Class 2
·Radiology
WINRAD TELERADIOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SEDLACEK HANDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FRESENIUS
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 19, 2014
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·February 6, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 4, 2011
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020