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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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Cognition Snapshot+ v2.4 - 00860011850922

No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution

  • 00860011850922 ()


  • Cognitive assessment software

MSPT Web v3.1.0 - 00860011850915

No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software

MSPT v3.1.1 - 00860011850908

No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution

  • 00860011850908 ()


  • Cognitive assessment software

Simpleware Medical - 00860011545705

Simpleware Medical image processing. Applicable software versions (UDI-PI) (01)00860011545705(8012)V-2024.06 (01)00860011545705(8012)W-2024.12 (01)00860011545705(8012)X-2025.06
SYNOPSYS, INC.
V-2024.06 -
In Commercial Distribution

  • 00860011545705 ()


  • Radiological PACS software

BrainCheck Assess - 00860011154501

BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment 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
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