6 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COVER-ROLL STRETCH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
FDA 510(k)
FDA Class 2
·Cardiovascular
SMALL TITANIUM WRIST FUSION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXIMA? APDL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FFA·May 21, 2014
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 29, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 30, 2007