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 Class Implantable

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PHILIPS HEARLINK 2 1.3.0 ANDROID
Sbo Hearing A/S
269357
In Commercial Distribution

  • 05714464133970 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK 3 1.2.0 ANDROID
Sbo Hearing A/S
265709
In Commercial Distribution

  • 05714464127184 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.2.0 ANDROID
Sbo Hearing A/S
265707
In Commercial Distribution

  • 05714464127160 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 ANDROID
Sbo Hearing A/S
264787
In Commercial Distribution

  • 05714464125210 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274916
In Commercial Distribution

  • 05714464146079 ()


  • Hearing aid/implant system remote control
DreamMapper Mobile App Android (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048553 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048546 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (DMM)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048539 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047518 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047501 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042025 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041998 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046825 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046795 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044418 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044388 ()
1127960

  • Self-care monitoring/reporting software
Tandem t:slim Mobile Application, Android
Tandem Diabetes Care, Inc.
1014706
In Commercial Distribution

  • 00389152470641 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
DreamMapper Mobile App Android (APAC)
Respironics, Inc.
DreamMapper Mobile App Android, Asia- Pacific Instance - 2
In Commercial Distribution

  • 00606959057678 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
DreamMapper Mobile App Android EMEA, - 2
In Commercial Distribution

  • 00606959057661 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (DMM)
Respironics, Inc.
DreamMapper Mobile App Android, North America Instance - 2
In Commercial Distribution

  • 00606959057654 ()
1101479

  • Self-care monitoring/reporting software
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
SW M01G02 CARELINK SMARTSYNC ANDROID
MEDTRONIC, INC.
M01G02
In Commercial Distribution

  • 00643169833715 ()


  • Implantable cardiac device management application software
Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software
Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software
TRUE MANAGER AIR APP - Android
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Android
In Commercial Distribution

  • 00021292013622 ()


  • Self-care monitoring/reporting software
Engage Android OTC Rechargeable Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831528 ()
10098

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831504 ()
10096

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831429 ()
10080

  • Air-conduction hearing aid, receiver-in-the-ear
Elite HA Android Package - Grey
HEARING LAB TECHNOLOGY, LLC
546*
In Commercial Distribution

  • 00810068830309 ()
HLT-ELITE-A-GR

  • Air-conduction hearing aid, receiver-in-the-ear
Elite HA Android Package - Black
HEARING LAB TECHNOLOGY, LLC
546*
In Commercial Distribution

  • 00810068830293 ()
HLT-ELITE-A-BK

  • Air-conduction hearing aid, receiver-in-the-ear
Elite HA Android Package - Beige
HEARING LAB TECHNOLOGY, LLC
546*
In Commercial Distribution

  • 00810068830286 ()
HLT-ELITE-A-BG

  • Air-conduction hearing aid, receiver-in-the-ear
Pro HA Android Package - Grey
HEARING LAB TECHNOLOGY, LLC
246*
In Commercial Distribution

  • 00810068830248 ()
HLT-PRO-A-GR

  • Air-conduction hearing aid, receiver-in-the-ear
Pro HA Android Package - Black
HEARING LAB TECHNOLOGY, LLC
246*
In Commercial Distribution

  • 00810068830231 ()
HLT-PRO-A-BK

  • Air-conduction hearing aid, receiver-in-the-ear
Pro HA Android Package - Beige
HEARING LAB TECHNOLOGY, LLC
246*
In Commercial Distribution

  • 00810068830224 ()
HLT-PRO-A-BG

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 16ch WL Android White
HEARING LAB TECHNOLOGY, LLC
9460
In Commercial Distribution

  • 00812944028824 ()
HLT-A16WL-PW

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 16ch WL Android Grey
HEARING LAB TECHNOLOGY, LLC
9460
In Commercial Distribution

  • 00812944028817 ()
HLT-A16WL-GR

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 16ch WL Android Brown
HEARING LAB TECHNOLOGY, LLC
9460
In Commercial Distribution

  • 00812944028800 ()
HLT-A16WL-BR

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 16ch WL Android Black
HEARING LAB TECHNOLOGY, LLC
9460
In Commercial Distribution

  • 00812944028794 ()
HLT-A16WL-BK

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 32ch WL Android White
HEARING LAB TECHNOLOGY, LLC
1460
In Commercial Distribution

  • 00812944028787 ()
HLT-A32WL-PW

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 32ch WL Android Grey
HEARING LAB TECHNOLOGY, LLC
1460
In Commercial Distribution

  • 00812944028770 ()
HLT-A32WL-GR

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 32ch WL Android Brown
HEARING LAB TECHNOLOGY, LLC
1460
In Commercial Distribution

  • 00812944028763 ()
HLT-A32WL-BR

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 32ch WL Android Black
HEARING LAB TECHNOLOGY, LLC
1460
In Commercial Distribution

  • 00812944028756 ()
HLT-A32WL-BK

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 96ch WL Android White
HEARING LAB TECHNOLOGY, LLC
4460
In Commercial Distribution

  • 00812944028749 ()
HLT-U96WLA-PW

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 96ch WL Android Grey
HEARING LAB TECHNOLOGY, LLC
4460
In Commercial Distribution

  • 00812944028732 ()
HLT-U96WLA-GR

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 96ch WL Android Brown
HEARING LAB TECHNOLOGY, LLC
4460
In Commercial Distribution

  • 00812944028725 ()
HLT-U96WLA-BR

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 96ch WL Android Black
HEARING LAB TECHNOLOGY, LLC
4460
In Commercial Distribution

  • 00812944028718 ()
HLT-U96WLA-BK

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 16ch WL Android Beige
HEARING LAB TECHNOLOGY, LLC
9460
In Commercial Distribution

  • 00812944028701 ()
HLT-A16WL-BG

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 32ch WL Android Beige
HEARING LAB TECHNOLOGY, LLC
1460
In Commercial Distribution

  • 00812944028695 ()
HLT-A32WL-BG

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 96ch WL Android Beige
HEARING LAB TECHNOLOGY, LLC
4460
In Commercial Distribution

  • 00812944028688 ()
HLT-U96WLA-BG

  • Air-conduction hearing aid, receiver-in-the-ear
Universal 16ch WL Android Grey
HEARING LAB TECHNOLOGY, LLC
9460
In Commercial Distribution

  • 00812944028626 ()
HLT-A16WL-GR

  • Air-conduction hearing aid, receiver-in-the-ear
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