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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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PARO Robot - 04580537541222

A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medical Device Biofeedback Medical Device For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Gold
In Commercial Distribution

  • 04580537541222 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541215

A baby seal type robot with artificial intelligence Neurological Therapeutic Medical Device Biofeedback Medical Device For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC White
In Commercial Distribution

  • 04580537541215 ()
V9-14UC

  • Psychophysiological biofeedback system

AeroDR X70 - 04560141946231

No Description
KONICA MINOLTA, INC.
AACT
In Commercial Distribution

  • 04560141946231 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300086

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17Ce
In Commercial Distribution

  • 04719879300086 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300079

No Description
INNOCARE OPTOELECTRONICS CORPORATION
F14G
In Commercial Distribution

  • 04719879300079 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300062

No Description
INNOCARE OPTOELECTRONICS CORPORATION
F14C
In Commercial Distribution

  • 04719879300062 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300055

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17Ge
In Commercial Distribution

  • 04719879300055 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300048

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17G
In Commercial Distribution

  • 04719879300048 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300031

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17C
In Commercial Distribution

  • 04719879300031 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300024

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V14G
In Commercial Distribution

  • 04719879300024 ()


  • Stationary basic diagnostic x-ray system, digital
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