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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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SMART Bun-Yo-Matic™ CT - 06429810209030

No Description
Disior Oy
1.0
In Commercial Distribution

  • 06429810209030 ()


  • CAD/CAM software

Burn Navigator - B2551143

Burn Navigator RX
ARCOS, INC.
RX
In Commercial Distribution

  • B2551143 ()
1143

  • Clinical information system web-based application software

Burn Navigator - B2551125

Burn Navigator H2 Transport
ARCOS, INC.
H2 Transport
In Commercial Distribution

  • B2551125 ()
1125

  • Clinical information system web-based application software

Burn Navigator - B2551120

Burn Navigator H2 model
ARCOS, INC.
H2
In Commercial Distribution

  • B2551120 ()
1120

  • Clinical information system web-based application software

Viz ICH+ - 00811852030349

Viz ICH+ v1.3 (2025-04-06)
VIZ.AI, INC.
Viz ICH+ Software
In Commercial Distribution

  • 00811852030349 ()


  • Radiology DICOM image processing application software

Viz HCM - 00811852030332

Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution

  • 00811852030332 ()


  • Cardiopulmonary physiological parameter analysis software

Viz RV/LV - 00811852030295

Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution

  • 00811852030295 ()


  • Radiology DICOM image processing application software

TeraRecon Aorta.CT - AORTACT01

TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
Terarecon Inc.
Aorta.CT01
In Commercial Distribution

  • AORTACT01 ()
Aorta.CT

  • Radiology DICOM image processing application software

HipMap Femoroacetabular Impingement Analysis - 07613327382570

No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution

  • 07613327382570 ()
3105001000

  • Radiology DICOM image processing application software

HipCheck - 07613327459081

No Description
STRYKER CORPORATION
01030300
In Commercial Distribution

  • 07613327459081 ()
0103-0300

  • Radiology DICOM image processing application software
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