7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CROSS PIN
FDA 510(k)
FDA Class 2
·Orthopedic
Comfort Cover
FDA 510(k)
FDA Class 2
·Radiology
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER
FDA 510(k)
FDA Class 2
·Radiology
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 14, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 14, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 6, 2016