7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LANCER ANALYZER CUPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
FDA 510(k)
FDA Class 2
·Cardiovascular
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 17, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2012
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Death
·MEDTRONIC SPINE LLC·Product code NDN·September 3, 2010
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