51 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131165374·K140, ITE VC AT WL L BE
Indus
FDA UDI
SPINEFRONTIER, INC.·00190361035756·Indus Invue MAX Symmetrical ACP, 4 Level, 77mm
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
FDA 510(k)
FDA Class 2
·Ophthalmic
OUTBACK CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 28, 2024
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 30, 2013
Y-SHAPED BLOOD SET W/ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·September 12, 2013
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026
IMP,TSV,6.0,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 15, 2025
Y-SHAPED BLOOD SET W/ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code BRZ·September 13, 2013
IMP,TSV,3.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 12, 2024
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 6, 2013
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 17, 2013
NDEHP Y-BLOOD SET W/FILTER PUMP 203CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 24, 2011
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 10, 2024
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 6, 2013
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 10, 2013