8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIRGO HSV-2 IGG ELISA
FDA 510(k)
FDA Class 2
·Microbiology
URIC ACID REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code KNK·April 15, 2011
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOMATED ELECTROPHORESIS SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·December 21, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Death
·INVACARE·Product code ITI·October 22, 2010
AFFINITY THREE BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code KNC·February 20, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015