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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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CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM - 09321502029469

CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM
COCHLEAR LIMITED
Z494179
In Commercial Distribution

  • 09321502029469 ()
Z494179

  • Audiometric/hearing device software

CareLink® - 00613994749208

SOFTWARE MMT-7335 V2.3 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994749208 ()


  • Patient health record information system application software

CareLink® - 00613994342805

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

  • 00613994342805 ()


  • Patient health record information system application software

not applicable - 00195278719812

Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

N/A - 00763000975029

SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer

CGMS® Solutions™ - 00613994675293

SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system

Dexcom G5 Mobile Android App - 00386270000293

G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom G5 Mobile IOS App - 00386270000002

G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Esteem® Commander™ - 00812282020504

Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system

Esteem® Commander™ - 00812282020481

Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system
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