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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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Abbott RealTime HBV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
02N43-004
In Commercial Distribution

  • 00884999042667 ()
02N43-004

  • Laboratory instrument/analyser application software IVD
Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
08L21-002
In Commercial Distribution

  • 00884999042513 ()
08L21-002

  • Laboratory instrument/analyser application software IVD
Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
2N43-03
In Commercial Distribution

  • 00884999037762 ()
2N43-03

  • Laboratory instrument/analyser application software IVD
Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
4N45-03
In Commercial Distribution

  • 00884999037656 ()
4N45-03

  • Laboratory instrument/analyser application software IVD
Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0
ABBOTT MOLECULAR INC.
6L83-06
In Commercial Distribution

  • 00884999037168 ()
6L83-06

  • Laboratory instrument/analyser application software IVD
Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0
ABBOTT MOLECULAR INC.
06L98-05
In Commercial Distribution

  • 00884999037113 ()
06L98-05

  • Laboratory instrument/analyser application software IVD
Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0
ABBOTT MOLECULAR INC.
08L21-01
In Commercial Distribution

  • 00884999034266 ()
08L21-01

  • Laboratory instrument/analyser application software IVD
Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001387 ()


  • Ultrasound imaging system application software
No Description
MCKESSON TECHNOLOGIES INC.
15.2
In Commercial Distribution

  • 80010939010014 ()


  • Anaesthesia information system application software
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software
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