7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE HEATED WIRE LOOPS 48 AND 72
FDA 510(k)
FDA Class 2
·Anesthesiology
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CAAS MRV VERSION 3.0
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 7, 2010
MUSTANG¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·December 6, 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