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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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Intraoral Camera
DENTERPRISE INTERNATIONAL, INC.
1000
In Commercial Distribution

  • 00858475006115 ()
01MAG10000

  • Intraoral camera
Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd.
ABPM50
In Commercial Distribution

  • 06945040106296 ()


  • Blood pressure ambulatory recorder
Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd.
ABPM50
In Commercial Distribution

  • 06945040100348 ()


  • Blood pressure ambulatory recorder
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
Audiometer - Model 650AB
AMBCO ELECTRONICS
650AB
In Commercial Distribution

  • 00851195007011 ()
650AB

  • Tone audiometer
AMBCO Audiometer - Model 650A
AMBCO ELECTRONICS
650A
In Commercial Distribution

  • 00851195007004 ()
650A

  • Tone audiometer
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 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
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
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