6 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
gammaCore-2
FDA 510(k)
FDA Class 2
·Neurology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·January 20, 2011