7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U1 HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEPUY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·March 8, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·February 16, 2011
NOVA MAX PLUS GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP.·Product code CGA·July 24, 2014
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 13, 2025