46 results · 24ms · Sources: EU EUDAMED, 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