7 results
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17ms
·
Sources: EU EUDAMED, US FDA
CALCIUM PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HITCH LACTOSORB SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
NON-INVASIVE, BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·June 10, 2014
KAPPA 600 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 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