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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Nitrile Examination Gloves
TEC GLOVES USA, LLC
X Large
In Commercial Distribution

  • 00860009233577 ()
  • 00860009233539 ()
TC21NXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
3.X
In Commercial Distribution

  • 00850005944430 ()
81-02315-00R

  • Magnetic neural stimulation system
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
2.X
In Commercial Distribution

  • 00850005944423 ()
81-01315-00R

  • Magnetic neural stimulation system
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution

  • 00628011382184 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution

  • 00628011382177 ()


  • Radiation therapy software
No Description
BONRAYBIO CO., LTD.
X QC
In Commercial Distribution

  • 04719874740733 ()


  • Sperm concentration indicator IVD, control
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
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