7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SHAMPAINE RADI-OP MODEL 1700RC
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK AVIVA TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
FDA 510(k)
FDA Class 2
·Radiology
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
MERIT ASPIRATION CAHTETER
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXE·December 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