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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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Visual Obturator with AI sheath scope lock
Avalign Technologies, Inc.
72-3130073
In Commercial Distribution

  • 00190776209667 ()


  • ENT examination/treatment system
FIBER LIGHT CABLE w AI INSTRUMENT CONNECTORS
Avalign Technologies, Inc.
72-9819
In Commercial Distribution

  • 00190776191177 ()


  • Fibreoptic retractor handle
FIBER OPTIC CABLE FOR RETRACTORS AI ADAPTOR
Avalign Technologies, Inc.
MFOC-10R
In Commercial Distribution

  • 00190776189686 ()


  • Electrical-only medical device connection cable, reusable
Fiberoptic Cable A AF Blue AI Cable
Avalign Technologies, Inc.
FTIMG166288BL
In Commercial Distribution

  • 00190776189570 ()


  • Electrical-only medical device connection cable, reusable
Optiloc® Laboratory Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759030 ()
3202.0002-OPT

  • Dental precision attachment fitting/adjustment tool
RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution

  • 00732094223910 ()
411215

  • Retinal image analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
In Commercial Distribution



  • Retinal image analysis software
AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
Aeye Health, Inc.
AEYE-DS-Epic
Not in Commercial Distribution

  • 00850035651018 ()


  • Retinal image analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution

  • 00850035651001 ()


  • Retinal image analysis software
No Description
Digital Diagnostics Inc.
v2.3
In Commercial Distribution

  • 00860005195626 ()


  • Retinal image analysis software
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