7 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCISE LIGHT CURED WHITE SEALANT
FDA 510(k)
FDA Class 2
·Dental
LEAP FROG
FDA 510(k)
FDA Class 2
·Cardiovascular
FIBRI-PREST AUTOMATE HA34
FDA 510(k)
FDA Class 2
·Hematology
COULTER ACT 5 DIFF CAP PIERCE (CP)
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 2, 2014
DRB1 04 SSP UNITRAY KIT
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORPORATION·Product code IYO·November 8, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
Various Angiography packs/trays
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022