7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DICON AUTO PERIMETER 200
FDA 510(k)
FDA Class 1
·Ophthalmic
READYSWIM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
FDA 510(k)
FDA Class 2
·Radiology
ASCENDRA 3 DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code NPT·May 15, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015
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