7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GLUCOFACTS DATA PRINTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·June 10, 2014
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 6, 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