6 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTGUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENAPULSE MODELS VP-25 AND VP-50
FDA 510(k)
FDA Class 2
·Cardiovascular
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
FDA 510(k)
FDA Class 2
·Neurology
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·February 15, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·January 11, 2011