7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BEHRING NEPHELOMETER SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BIFIX QM
FDA 510(k)
FDA Class 2
·Dental
VACUUM RELIEF VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
RENASYS GO RENTAL DEVICE
FDA Adverse Event
Malfunction
·SMITH & NEPHEW WOUND MANAGEMENT·Product code BTA·June 10, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 7, 2010
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 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