7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SEVIIN SURFACE REPLACEMENT SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
THE OBSIDIAN PACS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 16, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 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