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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IOS VMAX SERIES OPTION-ICU CART
VYAIRE MEDICAL, INC.
776268-103
In Commercial Distribution

  • 10190752164154 ()
776268-103

  • Neonatal/adult intensive-care ventilator
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042018 ()
1128264

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

  • 00606959044401 ()
1128264

  • Self-care monitoring/reporting software
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
PHILIPS HEARLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215186
In Commercial Distribution

  • 05714464004621 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215184
In Commercial Distribution

  • 05714464004607 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.1.0 IOS
Sbo Hearing A/S
215182
In Commercial Distribution

  • 05714464004584 ()


  • Hearing aid/implant system remote control
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,IOS
Gn Hearing A/S
20681400
In Commercial Distribution

  • 05708296095568 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,IOS
Gn Hearing A/S
20663900
In Commercial Distribution

  • 05708296095292 ()


  • Hearing aid/implant system remote control
APP,AUDIGY ATTUNE,1.2,IOS
Gn Hearing A/S
20789000
In Commercial Distribution

  • 05708296097241 ()


  • Hearing aid/implant system remote control
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
PHILIPS HEARLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246112
In Commercial Distribution

  • 05714464059782 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246110
In Commercial Distribution

  • 05714464059768 ()


  • Hearing aid/implant system remote control
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