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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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Viz Subdural+ v1.1 (2025-07-10)
VIZ.AI, INC.
Viz Subdural+ Software
In Commercial Distribution

  • 00811852030363 ()


  • Radiology DICOM image processing application software
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 v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution

  • 00811852030332 ()


  • Cardiopulmonary physiological parameter analysis software
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 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
No Description
STRYKER CORPORATION
01030300
In Commercial Distribution

  • 07613327459081 ()
0103-0300

  • Radiology DICOM image processing application software
No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution

  • 07613327382570 ()
3105001000

  • Radiology DICOM image processing application software
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution

  • 00810038851983 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_UI
In Commercial Distribution

  • 07290019352037 ()


  • Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Seamless
In Commercial Distribution

  • 07290019352020 ()


  • Ultrasound imaging system application software
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