46 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
IPLAN RT IMAGE
FDA 510(k)
FDA Class 2
·Radiology
INBONE II TOTAL ANKLE REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 10, 2014
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·July 7, 2011
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 2013
ARTERIAL PRESSURE MONITORING TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·December 3, 2024
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
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
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
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