7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MENTOR FLAT-SPAN
FDA 510(k)
FDA Unclassified
·Unknown
NIMETIC-DISPERS
FDA 510(k)
FDA Class 2
·Dental
EVIS EXERA II 180 SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRANSVENOUS LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
2520274-2012-03652
FDA Adverse Event
Injury
·SYNTHES·Product code UNK·December 7, 2012
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·June 16, 2015
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