7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
FDA 510(k)
FDA Class 2
·Neurology
Full Automatic (NIBP) Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
VICKS
FDA Adverse Event
Other
·KAZ INC·Product code IRT·November 26, 2012
4FX50CM SGL PRO PICC CT
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·September 24, 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