7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PreXion3D Expedition
FDA 510(k)
FDA Class 2
·Radiology
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
FDA 510(k)
FDA Class 1
·Microbiology
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·April 7, 2020
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·November 4, 2008
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JJE·September 2, 2011
GII STANDARD TIBIA B
FDA Adverse Event
SMITH & NEPHEW, INC.·Product code JWH·July 17, 2013