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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
TOPCON CORPORATION
IMAGEnet 6
In Commercial Distribution

  • 04562123288582 ()


  • Ophthalmology PACS software
No Description
TOPCON CORPORATION
IMAGEnet 5
In Commercial Distribution

  • 04562123288308 ()


  • Camera application software
ULTRASOUND DATA ANALYSIS SYSTEM
HITACHI, LTD.
DAS-RS1
Not in Commercial Distribution

  • 04562122958639 ()


  • Radiological PACS software
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
Vision testing application - HCP Portal
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376119 ()


  • Vision self-testing software
Vision testing application - android version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376102 ()


  • Vision self-testing software
No Description
STRYKER CORPORATION
910-01947
In Commercial Distribution

  • 00860002177779 ()
910-01947

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.3.0
In Commercial Distribution

  • 00860002177748 ()
910-01956

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.2.0
In Commercial Distribution

  • 00860002177717 ()
910-01955

  • Alarm application software
Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia.
CLEERLY, INC.
v1.0
In Commercial Distribution

  • 00860001924121 ()


  • Radiological PACS software
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