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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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Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10559
In Commercial Distribution

  • 15420045508019 ()
ASY-10559

  • Stationary mammographic x-ray system, digital
Cervical-Stim Bone Growth Stimulator
Orthofix US LLC
2505DA
In Commercial Distribution

  • 18257200007165 ()


  • Patient-worn bone growth electromagnetic stimulator
Cervical-Stim Bone Growth Stimulator
Orthofix US LLC
2505A
In Commercial Distribution

  • 18257200007158 ()


  • Patient-worn bone growth electromagnetic stimulator
Spinal-Stim Bone Growth Stimulator
Orthofix US LLC
2212DA
In Commercial Distribution

  • 18257200007127 ()


  • Patient-worn bone growth electromagnetic stimulator
Spinal-Stim Bone Growth Stimulator
Orthofix US LLC
2212A
In Commercial Distribution

  • 18257200007110 ()


  • Patient-worn bone growth electromagnetic stimulator
Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution

  • 15420045512474 ()
ASY-15431

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10559-BR
In Commercial Distribution

  • 15420045518094 ()
ASY-10559-BR

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10559-V20
In Commercial Distribution

  • 15420045518025 ()
ASY-10559-V20

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10559-V2.1
In Commercial Distribution

  • 15420045518018 ()
ASY-10559-V2.1

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10559-CN
In Commercial Distribution

  • 15420045518001 ()
ASY-10559-CN

  • Stationary mammographic x-ray system, digital
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