7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BASICAM S COUNTER BALANCE CAMERA
FDA 510(k)
FDA Class 1
·Radiology
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TITAN GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
LIBERTY CYCLER SET, SINGLE PATIENT CONN
FDA Adverse Event
Injury
·REYNOSA MANUFACTURING·Product code FKX·December 5, 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