7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLR BIPOLAR HIP ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
DMS Disposable Subdermal Needle Electrodes
FDA 510(k)
FDA Class 2
·Neurology
PRIMUS GPS BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010
PCA EMPTY STERILE
FDA Adverse Event
Malfunction
·HOSPIRA INC·Product code MEA·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