7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ENTERIC TUBE GUIDE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BioGenesis Fertility Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NEUROMONITOR BASIC KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·May 5, 2014
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
SINGLE 8 EXTENSION, 60CM LENGTH
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010
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