15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMC Health VitalCaregiving System
FDA 510(k)
FDA Class 2
·Cardiovascular
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674912·
KANEKA PHARMA AMERICA XPRESS-WAY RX
FDA 510(k)
FDA Class 2
·Cardiovascular
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
8MM BD ULTRA FINE¿ III PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 9, 2018
EON MINO
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 6, 2014
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 7, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·July 6, 2011
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code MMY·March 17, 2014
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code DXE·October 23, 2012
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORP.·Product code DXE·December 21, 2012
THROMBUSTER II
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DXE·January 16, 2019
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014