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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
AMPLIVOX LIMITED
Model 260
In Commercial Distribution

  • 05060488901027 ()


  • Tone audiometer
Intraoral Camera
DENTERPRISE INTERNATIONAL, INC.
1000
In Commercial Distribution

  • 00858475006115 ()
01MAG10000

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

  • 10194665007935 ()


  • Intraoral camera
KaVo DIAGNO cam Vision Full HD camera Kit
A-DEC, INC.
54.1041.00
In Commercial Distribution

  • 10194665007928 ()
54.1041.00

  • Intraoral camera
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 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
1.0.0
Not in Commercial Distribution

  • 05430000733007 ()


  • Bioelectrical signal analysis software
REMOTE TISSUE FILTER ADAPTER
Hologic, Inc.
ATEC RTFA
In Commercial Distribution

  • 05420045503178 ()
  • 15420045503175 ()
ATEC RTFA

  • Mammographic stereotactic biopsy system
No Description
Orfit Industries NV
60119-U
In Commercial Distribution

  • 05420028772577 ()


  • Tone audiometer
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
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000088 ()
-

  • MRI phantom, test object
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