8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLASIONOMER BASE CEMENT
FDA 510(k)
FDA Class 2
·Dental
BIS
FDA UDI
Covidien LP·10884521157545·A2000 Monitoring System,Refurbished
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 7, 2010
AXIUM 3-D DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·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