7 results
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18ms
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Sources: EU EUDAMED, US FDA
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Multi Modality Viewer
FDA 510(k)
FDA Class 2
·Radiology
TECO MICROALBUMIN 2-1 COMBO STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
JOHNSON & JOHNSON
FDA Adverse Event
Injury
·DEPUY INC., A JOHNSON & JOHNSON·Product code KWY·December 3, 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