7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
FDA 510(k)
FDA Class 2
·Orthopedic
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014
1.1MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code DQX·December 7, 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