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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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No Description
MEDICAL FEEDBACK TECHNOLOGIES LTD
BE8789US
In Commercial Distribution

  • 17290017875009 ()
  • 07290017875002 ()


  • Cardiopulmonary resuscitation feedback device, electronic
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution

  • 17290017855056 ()
  • 07290017855059 ()
FAU04000

  • Diagnostic x-ray digital imaging system workstation
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System performs ‎all required ‎processing and calculations based only on angiography images and hemodynamics ‎‎information that are acquired during the coronary catheterization procedure.‎
CATHWORKS LTD
FAU01000
In Commercial Distribution

  • 17290017855025 ()
  • 07290017855028 ()
FAU01000

  • Diagnostic x-ray digital imaging system workstation
VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
No Description
Philips Ultrasound LLC
989605465051
In Commercial Distribution

  • 00884838084322 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605496481
In Commercial Distribution

  • 00884838091672 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605492681
In Commercial Distribution

  • 00884838090736 ()


  • Radiological PACS software
A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution

  • 06430056480022 ()


  • Electroencephalograph
No Description
OTODYNAMICS LIMITED
OTOLINK
In Commercial Distribution

  • 05060396170591 ()


  • Evoked-potential audiometer
  • Otoacoustic emission system, battery-powered
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