49 results · 27ms · Sources: EU EUDAMED, US FDA

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CLIO/CLIOSOFT

FDA 510(k)
FDA Class 2 ·Radiology

INBONE II TOTAL ANKLE REPLACEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

SIMPLICITY WING INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 14, 2013

ENDOPROBE 23G TAPERED

FDA Adverse Event
Malfunction ·IRIDEX CORP.·Product code GEX·March 25, 2011

COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code KRH·August 11, 2008

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·November 8, 2022

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORP.·Product code OKS·August 19, 2014

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·January 13, 2017

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·January 5, 2017

BD INTIMA-II Y PRN/EC SLM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·November 9, 2022

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code OKS·December 25, 2016

LACRIFAST

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code OKS·June 2, 2021