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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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No Description
MED.E.COM
4.14
In Commercial Distribution

  • 03665587000019 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
MED.E.COM
4.15
Not in Commercial Distribution

  • 03665587000002 ()


  • Diagnostic x-ray digital imaging system workstation application software
The HappyNeuron Cognitive Training provides users with a program that is designed to be adapted for patients suffering from cognitive impairments linked to chronic diseases. Two programs have been designed so far targeting specific conditions: Multiple Sclerosis and Rheumatoid Arthritis. The cognitive training is a combination of scheduled workouts and on-demand complementary exercises. It contains computerized exercises that stimulate cognitive abilities (Memory, Attention, Language, Executive Functions and Visual-Spatial Skills). Coaching features guide the users through the exercises, adapt the difficulty settings dynamically, and follow-up on performance.
HAPPYNEURON
Version 1
In Commercial Distribution

  • 03665099000002 ()


  • Mental health/function therapeutic software, screen-viewed
Portable spirometer for lung function testing with oximetry function
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank II PLUS
In Commercial Distribution

  • 08052990322213 ()


  • Expiratory peak flow meter, digital
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649286 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software
Imaging System
LIGHTLAB IMAGING, INC.
Integrated System
In Commercial Distribution

  • 00183739000937 ()
C408652

  • Coronary optical coherence tomography system
Imaging System
LIGHTLAB IMAGING, INC.
C408650
In Commercial Distribution

  • 00183739000678 ()
C408650

  • Coronary optical coherence tomography system
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