12 results
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24ms
·
Sources: EU EUDAMED, US FDA
Resmon PRO FULL
FDA 510(k)
FDA Class 2
·Anesthesiology
TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
3T HD BREAST ARRAY
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 20, 2024
VIRTUOSO DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 7, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
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