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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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myVisionTrack - 00860003376157

Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software

myVisionTrack - 00860003376119

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

  • 00860003376119 ()


  • Vision self-testing software

myVisionTrack - 00860003376102

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

  • 00860003376102 ()


  • Vision self-testing software

UltraGATEWAY - 00860002319803

DICOM Router
ULTRARAD CORPORATION
4.0.10.27
In Commercial Distribution

  • 00860002319803 ()


  • Radiological PACS software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177786

No Description
STRYKER CORPORATION
EMDAN 2.3.1
In Commercial Distribution

  • 00860002177786 ()
910-01957

  • Alarm application software

Engage Medical Device Alert Notification System (EMDAN) - 00860002177779

No Description
STRYKER CORPORATION
910-01947
In Commercial Distribution

  • 00860002177779 ()
910-01947

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177762

No Description
STRYKER CORPORATION
EMDAN 2.5.0
In Commercial Distribution

  • 00860002177762 ()
910-01959

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177755

No Description
STRYKER CORPORATION
EMDAN 2.4.0
In Commercial Distribution

  • 00860002177755 ()
910-01958

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177748

No Description
STRYKER CORPORATION
EMDAN 2.3.0
In Commercial Distribution

  • 00860002177748 ()
910-01956

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177731

No Description
STRYKER CORPORATION
EMDAN 2.1.1
In Commercial Distribution

  • 00860002177731 ()
910-01954

  • Alarm application software
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