7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MCCOY CELLS
FDA 510(k)
FDA Class 1
·Hematology
NEEDLE CATHETER JEJUNOSTOMY KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UniSpace® Stand-Alone C Cage
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
ICS INFINITY CENTRAL STATION
FDA Adverse Event
Death
·DRAEGER MEDICAL SYSTEMS, INC.·Product code MHX·November 9, 2012
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·Product code NBW·September 14, 2010
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019