7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPENDABOND
FDA 510(k)
FDA Class 2
·Dental
SYMMETRY BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Xsert Lumbar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 14, 2014
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 7, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 6, 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