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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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NeuroMatch - 00850056774000

NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution

  • 00850056774000 ()


  • Bioelectrical signal analysis software

Persyst ESI powered by Epilog - 05430000733045

Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

PreOp - 05430000733021

PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

Orfit Industries - 05420028772577

No Description
Orfit Industries NV
60119-U
In Commercial Distribution

  • 05420028772577 ()


  • Tone audiometer

Amplivox - 05060488901171

No Description
AMPLIVOX LIMITED
Model 116
In Commercial Distribution

  • 05060488901171 ()


  • Tone audiometer

Amplivox - 05060488901164

No Description
AMPLIVOX LIMITED
Model 170
In Commercial Distribution

  • 05060488901164 ()


  • Tone audiometer

Amplivox - 05060488901102

No Description
AMPLIVOX LIMITED
Model 270
In Commercial Distribution

  • 05060488901102 ()


  • Tone audiometer

Amplivox - 05060488901034

No Description
AMPLIVOX LIMITED
Model 240
In Commercial Distribution

  • 05060488901034 ()


  • Tone audiometer

Amplivox - 05060488901027

No Description
AMPLIVOX LIMITED
Model 260
In Commercial Distribution

  • 05060488901027 ()


  • Tone audiometer

Acteon - 10194665007935

Camera, C20 Handpiece, Accessories
A-DEC, INC.
C20
In Commercial Distribution

  • 10194665007935 ()


  • Intraoral camera
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