8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
# 10099/10225/10235/10275/10525/10625/10715/10125
FDA 510(k)
FDA Class 1
·Anesthesiology
XenMatrix AB Surgical Graft
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KOTEX SECURITY TUBE TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LOGIC KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 9, 2026
ADVISA DR MRI SURESCAN
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 8, 2010
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·December 7, 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