11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIVIX-S 1012N
FDA 510(k)
FDA Class 2
·Radiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704509120·
UNIVERSAL IRRIGATION SOLUTION HYBRID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STARSPEED SERIES CT SCANNER SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023
ATTAIN ABILITY
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 8, 2013
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·June 28, 2011
GLOBAL ADVANTAGE PC STEM 8MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MBF·September 5, 2008
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023