7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
A-GENT LIQUID ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Perineologic Access Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
FDA 510(k)
FDA Class 2
·Hematology
SIGMA 100 VVI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·June 10, 2014
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·October 7, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 5, 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