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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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HLA Fusion™ Software (IVD) - 00814695022571

HLA Fusion Software for clinical diagnostics features analysis modules for One Lambda’s IVD products such as FlowPRA®, LABScreen®, LABType®, LCT™, Micro SSP™ and more.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022571 ()
FUSPGR

  • HLA class I & II antibody screening IVD, kit, multiplex
  • HLA class I & II antigen tissue typing IVD, kit, multiplex

cobas Liat Software Version 3.0 - 07613336119563

No Description
Roche Molecular Systems, Inc.
07886977001
Not in Commercial Distribution

  • 07613336119563 ()
07886977001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Virtual by Volk Telemedicine Software - 00811608019703

No Description
VOLK OPTICAL INC.
VTELEMED
In Commercial Distribution

  • 00811608019703 ()


  • Multidisciplinary medical image management software

cobas Liat Analyzer Software 3.2 - 07613336148259

No Description
Roche Molecular Systems, Inc.
08276412001
In Commercial Distribution

  • 07613336148259 ()
08276412001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

ROSA® KNEE SOFTWARE UPGRADE - 00889024511347

No Description
Orthosoft Inc
20-8020-140-01
In Commercial Distribution

  • 00889024511347 ()
20-8020-140-01

  • Robotic surgical navigation system application software

ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE - 04953170373848

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2190
In Commercial Distribution

  • 14953170373845 ()
  • 04953170373848 ()
N5400540

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT - 04953170360817

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2038
Not in Commercial Distribution

  • 04953170360817 ()
N5368840

  • Video capsule endoscopy system application software

Alignment Software Cranial with LITT - 04056481146337

No Description
Brainlab AG
2.1
In Commercial Distribution

  • 04056481146337 ()


  • Electromagnetic/optical surgical navigation device tracking system

Navigation Software KNEE3 3.2 Installer - 04056481138806

No Description
Brainlab AG
3.2
In Commercial Distribution

  • 04056481138806 ()
27001-01E

  • Robotic surgical navigation system

Navigation Software Fluoro Express Installer - 04056481137908

No Description
Brainlab AG
3.3
In Commercial Distribution

  • 04056481137908 ()
22084-03B

  • Robotic surgical navigation system
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