6 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
REPORT AND IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
AEQUALIS HUMERAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HX2 TEMPERATURE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·February 25, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LGD·February 9, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 24, 2014