7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Versana Balance
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
DEPUY MITEK, LLC·10886705007288·Cortical Screw 4.5mm x 46mm
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013