7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MIAMI-SUNNY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NORELCO ELECTRONIC BLOOD PRESSURE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
Lipogems System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·November 29, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
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