9 results
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26ms
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Sources: EU EUDAMED, US FDA
PHARMASEAL DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PREMIER(TM) Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902500381·PLATE 6861165 65 MM ANT CERV
Screw, Cannulated,7.0x165mm, Full Thread
FDA UDI
Pioneer Surgical Technology, Inc.·00846468041410·7.0x165mm, Full Thread
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
FDA 510(k)
FDA Class 2
·Immunology
Next Science Irrigation Solution
FDA 510(k)
FDA Class 2
·General Hospital
VIRTUOSO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 4, 2010
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 2, 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