7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
FACE TANNER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
InTRAkit
FDA 510(k)
FDA Class 2
·Cardiovascular
VERESS CANNULA AND MODULAR VERESS CANNULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 23, 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