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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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Mod LInk
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007211 ()


  • Radiological PACS software
Image Link Encounter Workflow
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007204 ()


  • Radiological PACS software
Image Link
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007198 ()


  • Radiological PACS software
PACS Scan Web
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007181 ()


  • Radiological PACS software
Aer X is a portable Oxygen concentrator
3B MEDICAL, INC.
Aer X
In Commercial Distribution

  • 00853041003000 ()
021000M

  • Mobile/portable oxygen concentrator
No Description
Tilite
TiLite X
In Commercial Distribution

  • 00853316008129 ()


  • Push-rim manual wheelchair, non-bariatric
No Description
Tilite
Aero X
In Commercial Distribution

  • 00853316008068 ()


  • Push-rim manual wheelchair, non-bariatric
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution

  • 00860007599118 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD
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