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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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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

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177724

No Description
STRYKER CORPORATION
EMDAN 1.10.0
In Commercial Distribution

  • 00860002177724 ()
910-01952

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177717

No Description
STRYKER CORPORATION
EMDAN 2.2.0
In Commercial Distribution

  • 00860002177717 ()
910-01955

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177700

No Description
STRYKER CORPORATION
EMDAN 2.1.0
In Commercial Distribution

  • 00860002177700 ()
910-01953

  • Alarm application software

Cleerly Ischemia - 00860001924121

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

Cleerly Labs - 00860001924114

Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries.
CLEERLY, INC.
v2.0
In Commercial Distribution

  • 00860001924114 ()


  • Radiological PACS software

Movive Education Unit - 00860001790832

Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution

  • 00860001790832 ()


  • Neuromuscular rehabilitation software
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