7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
KM-3 ACETABULAR COMPONENT
FDA 510(k)
FDA Class 3
·Orthopedic
SOLAR TAN - SOLARIA IV
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT INPERSOL CYCLER 1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 5, 2010
OPTIFLOW TRACHEOSTOMY DIRECT CONNECTION
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 3, 2012
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