7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Entrada hip stem
FDA 510(k)
FDA Class 2
·Orthopedic
STERIGAGE MODEL 1243RA, 1243RB, 1243RE
FDA 510(k)
FDA Class 2
·General Hospital
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERLINK SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·June 14, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 19, 2008
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018