7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART
FDA 510(k)
FDA Class 2
·Cardiovascular
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
FDA 510(k)
FDA Class 2
·Dental
XYcor® Expandable Spinal Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·October 26, 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