7 results
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19ms
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Sources: EU EUDAMED, US FDA
ALT/GPT PROCEDURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Anexa Wound Flush, Sterile Water & Sterile Normal Saline
FDA 510(k)
FDA Unclassified
·Unknown
SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L
FDA 510(k)
FDA Class 2
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 2012
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·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