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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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UbiqVue - B353UA2550C1

Active Monitoring Portal
Lifesignals, Inc.
UA2550-C
In Commercial Distribution

  • B353UA2550C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
  • Wearable multiple vital physiological parameter monitor

Scanner S900 ARTI 230 V with scan Software, PC and screen - D800SYAB0920

Scanner S900 ARTI 230 V with scan Software, PC and screen
ZIRKONZAHN SRL
SYAB0920
In Commercial Distribution

  • D800SYAB0920 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S600 - D800SY0186

Scanner S600 ARTI 120 V with scan software, PC and screen
ZIRKONZAHN SRL
SY0186
In Commercial Distribution

  • D800SY0186 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S600 - D800SY0095

Scanner S600 ARTI 230 V with scan Software, PC and screen
ZIRKONZAHN SRL
SY0095
In Commercial Distribution

  • D800SY0095 ()


  • Dental milling system, CAD/CAM, laboratory

Summit Radiographic table - B307S2230

Table, Radiologic (892.1980)
SUMMIT INDUSTRIES, LLC
S223
In Commercial Distribution

  • B307S2230 ()
S223

  • Multi-purpose diagnostic imaging table

Summit Radiographic table - B307S2100

Table, Radiologic (892.1980)
SUMMIT INDUSTRIES, LLC
S210
In Commercial Distribution

  • B307S2100 ()
S210

  • Multi-purpose diagnostic imaging table

Arterys MICA - B664AMM60

No Description
Arterys Inc.
AMM6
Not in Commercial Distribution

  • B664AMM60 ()


  • Radiology DICOM image processing application software

Tempus Pixel - B664AMM71

No Description
Arterys Inc.
AMM7
In Commercial Distribution



  • Radiology DICOM image processing application software

Arterys MICA - B664AMM70

No Description
Arterys Inc.
AMM7
Not in Commercial Distribution

  • B664AMM70 ()


  • Radiology DICOM image processing application software

Image Navigator® - M74900IN2201

Automated microscope system for immunofluorescent determination of autoantibodies.
IMMUNO CONCEPTS INC
IN220
In Commercial Distribution

  • M74900IN2201 ()
IN220

  • Cell morphology analyser IVD, automated/semi-automated
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