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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Hologic, Inc.
ASY-11748-3D
In Commercial Distribution

  • 15420045510395 ()


  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.
Hologic, Inc.
ASY-11748-2D
In Commercial Distribution

  • 15420045510388 ()
ASY-11748-2D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
ASY-10636-3D
In Commercial Distribution

  • 15420045508033 ()
ASY-10636-3D

  • 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-10636-2D
Not in Commercial Distribution

  • 15420045508026 ()
ASY-10636-2D

  • 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
In Commercial Distribution

  • 15420045508019 ()
ASY-10559

  • Stationary mammographic x-ray system, digital
PUMP MMT-1780KPK 670G V4.10 EN MG
MEDTRONIC MINIMED, INC.
MMT-1780KPK
In Commercial Distribution

  • 00763000090203 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
PUMP MMT-1715KR 630G V2.8 SF MG RECERT
MEDTRONIC MINIMED, INC.
MMT-1715KR
In Commercial Distribution

  • 00763000075439 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-1780KL 670G V3.18 BK SF MG
MEDTRONIC MINIMED, INC.
MMT-1780KL
In Commercial Distribution

  • 00763000072537 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-1715KL 630G V2.8 BK SF MG
MEDTRONIC MINIMED, INC.
MMT-1715KL
In Commercial Distribution

  • 00763000072520 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
KIT MMT-1755K 630G 3ML V4.10 BK EN
MEDTRONIC MINIMED, INC.
MMT-1755K
In Commercial Distribution

  • 00763000101527 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
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