8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COULTER CLONE T8 MONOCLONAL ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
MEDCARE WOUND CLOSURE TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
JUVEDERM VOLUMA XC 27G 2 X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 12, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 2, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·November 1, 2010
OEC UroView 2800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
OEC 9800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016