9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OTI MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZOOM-100DC
FDA 510(k)
FDA Class 2
·Neurology
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
FDA 510(k)
FDA Class 2
·Hematology
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·January 20, 2025
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W.L. GORE & ASSOCIATES·Product code MIH·October 22, 2014
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 9, 2022
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 31, 2013
CAPSURE Z NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 9, 2011
STOCKERT S5 SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 9, 2014