8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
A.X.T. SPOTFILM DEVICE
FDA 510(k)
FDA Class 2
·Radiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65888824921·Cysto Pack
Geminus Volar Distal Radius Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
REIGNING ARTIFICIAL TEETH
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 21, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 20, 2012
Cysto Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015