19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLO-ASSISTANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRUBYTE DENTURE BASE RESIN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ODONTOSURGE 3
FDA 510(k)
FDA Class 2
·Dental
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
LIFESHIELD LATEX FREE SYMBIQ PUMP SET
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2012
SERFAS ENERGY SUPER 90-S
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·April 8, 2013
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2011
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·May 8, 2008
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 1, 2010
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·January 7, 2011
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024