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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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Kosmos OTS Android Doppler Software Package - 09353278000700

Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software

Amplion Care Assurance - 00850016398352

Software for Messaging Controller, Version 1.8.7
AMPLION CLINICAL COMMUNICATIONS, INC.
S-MGC-187-1
Not in Commercial Distribution

  • 00850016398352 ()
S-MGC-187-1

  • Nurse call system

CareLink® - 00643169175341

SOFTWARE MMT-7335 V3.2 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00643169175341 ()


  • Patient health record information system application software

BioSticker™ System Offload Software - 00850005949046

Offload Software for the BioSticker System.
BIOINTELLISENSE, INC.
SWDT10001-1.1.1
In Commercial Distribution

  • 00850005949046 ()


  • Electrocardiography telemetric monitoring system transmitter

Leica Biosystems CytoVision Tissue FISH Software - 00849832004400

Leica Biosystems CytoVision Tissue FISH Software
Leica Biosystems Richmond, Inc.
23SWRTFHXXX001
Not in Commercial Distribution

  • 00849832004400 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision FISH Software Update - 00849832004394

Leica Biosystems CytoVision FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002FLX001
Not in Commercial Distribution

  • 00849832004394 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision FISH Software Upgrade - 00849832004387

Leica Biosystems CytoVision FISH Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001FLX001
Not in Commercial Distribution

  • 00849832004387 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Z-stack software license - 00849832004370

Leica Biosystems CytoVision Z-stack software license
Leica Biosystems Richmond, Inc.
23SWR000ZSX001
In Commercial Distribution

  • 00849832004370 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision MFISH Software License - 00849832004363

Leica Biosystems CytoVision MFISH Software License
Leica Biosystems Richmond, Inc.
23SWR000MFX001
Not in Commercial Distribution

  • 00849832004363 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Karyotyping Software Update - 00849832003793

Leica Biosystems CytoVision Karyotyping Software Update
Leica Biosystems Richmond, Inc.
23SWR002KLX001
Not in Commercial Distribution

  • 00849832003793 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
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