7 results
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17ms
·
Sources: EU EUDAMED, US FDA
MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE
FDA 510(k)
FDA Class 1
·Hematology
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
FDA 510(k)
FDA Class 1
·Microbiology
GALAXY
FDA 510(k)
FDA Class 2
·Cardiovascular
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014
IN TOUCH ZU
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·November 8, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
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