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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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3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative.
ANATOMAGE, INC.
6.0
In Commercial Distribution

  • 00852060007037 ()


  • Radiology information system application software
Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are to able examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either a touch interface or standard mouse and keyboard interactions.
ANATOMAGE, INC.
5.0.1
In Commercial Distribution

  • 00852060007013 ()


  • Radiology information system application software
3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative.
ANATOMAGE, INC.
6.0
In Commercial Distribution

  • 00852060007006 ()


  • Radiology information system application software
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
VG01
In Commercial Distribution

  • 05391548420036 ()
  • 05391548420029 ()
  • 05391548420043 ()
VGHS01

  • Biomechanical function analysis/rehabilitation software
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
2.2.0
Not in Commercial Distribution

  • 05391548420012 ()
VGCP01

  • Biomechanical function analysis/rehabilitation software
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
2
In Commercial Distribution

  • 05391548420005 ()
VGAPP01

  • Biomechanical function analysis/rehabilitation software
Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution

  • 05415067005861 ()
H700586

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution

  • 05415067002952 ()
H700295

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution

  • 05415067002938 ()
H700293

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution

  • 05415067002921 ()
H700292

  • Cardiac mapping system application software
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