7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROGENIX DMB PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
CBC PLT-4
FDA 510(k)
FDA Class 2
·Hematology
WEBSTER QUADROPOLAR - FIXED
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 26, 2012
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 13, 2014
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 13, 2012
ON-Q PAIN PUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·September 8, 2010