9 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Carriere® Motion Pro® Clear Bite Corrector
FDA 510(k)
FDA Class 2
·Dental
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813053829·PVS IMP MAT LB 50ML RS RASP
COBAS® WNV (192T)
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 22, 2025
Iridex 810 Laser
FDA 510(k)
FDA Class 2
·Ophthalmic
StageOne Select Hip Cement Spacer Molds
FDA 510(k)
FDA Class 2
·Orthopedic
LIBERTY CYCLER
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·November 13, 2014
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC·Product code JJE·September 9, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 29, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020