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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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VisionX - E247E7300A10

VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software

DBSWIN 5.11.0 - E247E72000

No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution

  • E247E72000 ()


  • General-purpose dental x-ray system application software

vascuCAP - B745VASCUCAPA2

No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution

  • B745VASCUCAPA2 ()


  • CT system application software

ElucidVivo - B745ELUCIDVIVOA3

No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution

  • B745ELUCIDVIVOA3 ()


  • CT system application software

vascuCAP - B745A40

No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution

  • B745A40 ()


  • CT system application software

SnapShot Freeze 2 - 00195278865335

SnapShot Freeze Medical Device
GE MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00195278865335 ()
5963072

  • CT system application software

Samsung Sleep Apnea Feature (Android OS) - 08806094936889

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936889 ()


  • Patient general health self-management software

Samsung Sleep Apnea Feature (Wear OS) - 08806094936872

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936872 ()


  • Patient general health self-management software

SnapShot Freeze - 00840682142601

No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00840682142601 ()


  • CT system application software

DLIR - 00840682146586

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682146586 ()


  • CT system application software
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