7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CREATINE PHROSPHOKINASE (CK) PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VLP Wrist Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 2012
CHATTANOOGA
FDA Adverse Event
Malfunction
·GBO MEDIZINTECHNIK AG·Product code IMJ·June 19, 2015
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