36 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT IPTH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CEW·March 19, 2025
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
FDA 510(k)
FDA Class 1
·General Hospital
CYBERCASES BY BAUSCH & LOMB
FDA 510(k)
FDA Class 2
·Ophthalmic
MICROBORE EXT SET
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·February 5, 2009
SOLUSET 100 BURETTE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·May 1, 2009
SOLUSET 100X60 CE-SL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·June 18, 2009
SOLUSET 100X60 CE-SL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·June 18, 2009
SOLUSET 150 BURETTE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 12, 2009
SOLUSET 100X60 CE-SL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·June 18, 2009
SOLUSET 100X60 CE-SL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·June 18, 2009
SVENTED IV PUMPSET/C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 20, 2009
EXTENSION SET WITH T-CONNECTOR (500/CS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·March 25, 2010
EXTENSION SET WITH T-CONNECTOR (500/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·March 25, 2010
EXTENSION SET WITH T-CONNECTOR (500/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD·Product code FPK·May 3, 2010
EXTENSION SET WITH T-CONNECTOR(500/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·December 16, 2009
NV FIL SOLUSET 100
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA·Product code FPA·December 27, 2011
SOLUSET 100X60W/ CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 19, 2013
NV FIL SOLUSET 100
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 22, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 26, 2013