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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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NTRAINER - 10885380195587

NTrainer System 2.0
Cardinal Health 200, LLC
1000NT
In Commercial Distribution

  • 10885380195587 ()
1000NT

  • Psychophysiological biofeedback system

NA - 00198953043301

Radiographic Table
GE Hualun Medical Systems Co., Ltd
GCTBL-C44
In Commercial Distribution

  • 00198953043301 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953043295

Gemini Tilting WS
GE Hualun Medical Systems Co., Ltd
GCEWS-C4
In Commercial Distribution

  • 00198953043295 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953043288

Gemini_Non-tilting_WS
GE Hualun Medical Systems Co., Ltd
GCWS-C6
In Commercial Distribution

  • 00198953043288 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953023266

G3A standard Wallstand
GE Hualun Medical Systems Co., Ltd
GCWS-C3
In Commercial Distribution

  • 00198953023266 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953023259

G4 Non-Tilting Wallstand
GE Hualun Medical Systems Co., Ltd
GCWS-C5
In Commercial Distribution

  • 00198953023259 ()


  • Stationary basic diagnostic x-ray system, digital

nfant® Thrive Feeding System - 00196852268917

No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00196852268917 ()
NTFS

  • Psychophysiological biofeedback system

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

Yushan - 04719879300017

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V14C
In Commercial Distribution

  • 04719879300017 ()


  • Stationary basic diagnostic x-ray system, digital

AeroDR X70 - 04560141946231

No Description
KONICA MINOLTA, INC.
AACT
In Commercial Distribution

  • 04560141946231 ()


  • Stationary basic diagnostic x-ray system, digital

PARO Robot - 04580537541246

A baby seal type robot with artificial intelligence in light Pink Color. Neurological Therapeutic Medical Device in 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 Pink
In Commercial Distribution

  • 04580537541246 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541239

A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological Therapeutic Medical Device in 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 Charcoal Gray
In Commercial Distribution

  • 04580537541239 ()
V9-14UC

  • Psychophysiological biofeedback system

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

Halifax Imaging Kit - 00628451892021

The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.
Halifax Biomedical Incorporated
1
In Commercial Distribution

  • 00628451892021 ()
P008943

  • Stationary basic diagnostic x-ray system, digital

DIGITAL RADIOGRAPHY SYSTEM - 04987670102196

DIGITAL RADIOGRAPHY SYSTEM
CANON MEDICAL SYSTEMS CORPORATION
DRAD-3000E
In Commercial Distribution

  • 04987670102196 ()


  • Stationary basic diagnostic x-ray system, digital

Neuroband - 00850010086026

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30MD
Not in Commercial Distribution

  • 00850010086026 ()


  • Psychophysiological biofeedback system

Neuroband - 00850010086033

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30SB
Not in Commercial Distribution

  • 00850010086033 ()


  • Psychophysiological biofeedback system

Dreem 2 - 00850010086019

Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
DREEM
EFM00MD
Not in Commercial Distribution

  • 00850010086019 ()


  • Psychophysiological biofeedback system

PodSKAN HF Diagnostic X-ray System - 08904269415105

PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A Wall socket with 120 VAC or 240 VAC, 50/60 Hz.. The technology incorporates feedback circuits to ensure highest accuracy & reproducibility of X-Ray output.
SKANRAY TECHNOLOGIES LIMITED
303-002665-0
In Commercial Distribution

  • 08904269415105 ()


  • Stationary basic diagnostic x-ray system, digital

SKANRAD 400 - 08904269409531

Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation
SKANRAY TECHNOLOGIES LIMITED
303-000783-4
In Commercial Distribution

  • 08904269409531 ()


  • Stationary basic diagnostic x-ray system, digital

RevoluX - 04719892352000

Hand Diagnostic Radiography Imaging System
NANORAY BIOTECH CO., LTD.
NDR705
In Commercial Distribution

  • 04719892352000 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 612SE - 04547410256970

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE W E
In Commercial Distribution

  • 04547410256970 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 602SE - 04547410256932

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE WIRED A W E
In Commercial Distribution

  • 04547410256932 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
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