7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
FDA 510(k)
FDA Class 2
·Cardiovascular
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
FDA 510(k)
FDA Class 2
·Dental
TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA
FDA 510(k)
FDA Class 1
·Microbiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2014
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·October 31, 2012
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 23, 2015
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