7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
KETA HAND-HELD TONOMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cadwell AmpliScan
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
CONTAK RENEWAL TR
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·October 7, 2010
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·December 3, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012