7 results
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36ms
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Sources: EU EUDAMED, US FDA
BIOTIS CETRIMIDE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
REAGENT, CHLORIDOMETER ACID
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRE-VAP CAPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SHILEY
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTH·Product code JOH·December 4, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·September 27, 2010
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