7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WELCH ALLYN TYMPANOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
G Surgical Marksman MIS System
FDA 510(k)
FDA Class 2
·Orthopedic
STAODYN MAX PRESET, MODEL 4470
FDA 510(k)
FDA Class 2
·Neurology
SENSIA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 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