7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BOMDAL STANDARD LIFT
FDA 510(k)
FDA Class 2
·General Hospital
SHILEY TEMPERATURE MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
INTEGRA SL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 29, 2012
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
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