7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CREATININE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERIMETER Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
8F SHERPA NX GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 5, 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