7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EGG-TOP TORP AND EGG-TOP PORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
FDA 510(k)
FDA Class 1
·Microbiology
O'NEIL URINARY CATHETER INTRODUCER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 10, 2014
MBT CEM KEEL TIB TRAY SZ5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·October 6, 2010
CVC SET: 3-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·December 5, 2012
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