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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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REMI Vigilenz - 00860005388189

REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software

REMI - 00860005388158

REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software

REMI - 00860005388110

REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution

  • 00860005388110 ()


  • Bioelectrical signal analysis software

Audhere Software - 00860005068319

No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer

WAHTS - 00860005068302

No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution

  • 00860005068302 ()


  • Tone audiometer

Acteon - 10194665007935

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

  • 10194665007935 ()


  • Intraoral camera

A-dec - 10194665007928

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

  • 10194665007928 ()
54.1041.00

  • Intraoral camera

Orfit Industries - 05420028772577

No Description
Orfit Industries NV
60119-U
In Commercial Distribution

  • 05420028772577 ()


  • Tone audiometer

ATEC - 05420045503178

REMOTE TISSUE FILTER ADAPTER
Hologic, Inc.
ATEC RTFA
In Commercial Distribution

  • 05420045503178 ()
  • 15420045503175 ()
ATEC RTFA

  • Mammographic stereotactic biopsy system

Stratus EEG - 05694110068071

The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Acquisition
In Commercial Distribution



  • Bioelectrical signal analysis software
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