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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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A software for personalizing and optimizing magnetic brain stimulation treatment.
Magnus Medical, Inc.
Magnus Cloud Software
In Commercial Distribution

  • 00860011072508 ()


  • Magnetic neural stimulation system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Review Software
In Commercial Distribution

  • 00840682100090 ()


  • Breast ultrasound imaging system
No Description
LivaNova Deutschland GmbH
Patient Monitor Software
In Commercial Distribution

  • 04033817903161 ()


  • Patient health record information system
software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG)
MICROMED SPA
BRAIN QUICK SOFTWARE
In Commercial Distribution

  • 08033928120958 ()


  • Bioelectrical signal analysis software
No Description
JENSEN INDUSTRIES INC.
Preciso CAD Software
Not in Commercial Distribution

  • 00817340022292 ()
EX003

  • Dental milling system, CAD/CAM, laboratory
No Description
LIGHTLAB IMAGING, INC.
D.2 Software
In Commercial Distribution

  • 00812059021338 ()
C408660

  • Coronary optical coherence tomography system
Viz CTP v1.14 (2025-04-06)
VIZ.AI, INC.
Viz CTP Software
In Commercial Distribution



  • Radiology DICOM image processing application software
Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution

  • B3943950010000 ()
395-0010-00

  • Centralized patient monitor
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution

  • B3943900008000 ()
390-0008-00

  • Centralized patient monitor
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