11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450225318·
CEMEX SYSTEM GUN APPLICATION VERSION
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES STERNAL FIXATION SYSTEM
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 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·May 2, 2011
ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 1, 2008
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 8, 2013
PINNACLE MTL INS NEUT36IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 8, 2013
UNKNOWN DEPUY DEVICE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 8, 2013
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016