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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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Kinesia StimPoint Application Software
Great Lakes Neurotechnologies Inc.
360-0050 Kinesia StimPoint Software
In Commercial Distribution

  • 00859584006195 ()
360-0050

  • Tremor transducer
Hearing Aid Fitting Software
INTRICON CORPORATION
hi-PS
In Commercial Distribution

  • 00858177007076 ()
22724

  • Hearing aid wireless-fitting computer-aided set
Dosimetry and QA Software
RADIOLOGICAL IMAGING TECHNOLOGY
113
In Commercial Distribution

  • 00857450006003 ()
RIT113

  • Accelerator system quality assurance device
Therapy cycling feedback software
ACCELERATED CARE PLUS CORP
OmniTourSoftware
In Commercial Distribution

  • 00858703006375 ()


  • Bioelectrical signal analysis software
Kinesia 360, Application Software
Great Lakes Neurotechnologies Inc.
360-0041, Application Software
In Commercial Distribution

  • 00859584006126 ()


  • Tremor transducer
Kinesia One, Application Software
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution

  • 00859584006119 ()


  • Tremor transducer
Secondary Check QA Software
VARIAN MEDICAL SYSTEMS, INC.
2.0.1
Not in Commercial Distribution

  • 00861334000315 ()
Mobius3D

  • Accelerator system quality assurance device
Dental Cloud Imaging Software
Sota Cloud Corp.
1
In Commercial Distribution

  • 00860013687632 ()


  • General-purpose dental x-ray system application software
Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software
Automated sleep scoring software.
ENSODATA, INC.
01.1
Not in Commercial Distribution

  • 00864458000407 ()


  • Sleep disorder interpretive software, professional-only
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