8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
POWERED TRACTION EQUIPMENT
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCENTO / HWA Dual/Single laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
FDA 510(k)
FDA Class 2
·Hematology
3.5MM CURVED RECONSTRUCTION PLATE 8 HOLES
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code KTW·May 16, 2013
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 2, 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