10,000 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAAS II QVA
FDA 510(k)
FDA Class 2
·Radiology
DLX M25.16 SW PACKAGE
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code IZI·September 15, 2005
CAAS QVA 3D, CAAS QCA 3D
FDA 510(k)
FDA Class 2
·Radiology
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·May 29, 2014
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·April 23, 2020
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020
ARTIS ICONO BIPLANE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH- AT·Product code OWB·March 24, 2020
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Malfunction
·REFLEXION MEDICAL, INC·Product code QVA·July 1, 2025
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL, INC.·Product code QVA·May 27, 2025
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026
REFLEXION MEDICAL RADIOTHERAPY SYSTEM
FDA Adverse Event
Injury
·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026