7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
API UNISCEPT PLUS 140 INOCULATOR
FDA 510(k)
FDA Class 1
·Microbiology
SPOR-O-THERM
FDA 510(k)
FDA Class 1
·Microbiology
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 14, 2012
SYNCHRON® LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 10, 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