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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APP,BT HEARP,4.0,IOS
Gn Hearing A/S
20993400
In Commercial Distribution

  • 05708296158447 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,IOS
Gn Hearing A/S
20993200
In Commercial Distribution

  • 05708296158423 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,IOS
Gn Hearing A/S
20993000
In Commercial Distribution

  • 05708296158409 ()


  • Hearing aid/implant system remote control
APP,MY LIVELY 1.4,IOS
Gn Hearing A/S
21123000
In Commercial Distribution

  • 05708296169702 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
APP,KS DISCOVER,1.4,IOS
Gn Hearing A/S
20665200
In Commercial Distribution

  • 05708296164295 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE,1.0.0,IOS
Gn Hearing A/S
22153200
In Commercial Distribution

  • 05708296229185 ()


  • 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
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
FW updater App 1.0.0 iOS
Sbo Hearing A/S
232872
In Commercial Distribution

  • 05714464033829 ()


  • Hearing aid wireless-fitting computer-aided set
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051331 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049932 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049086 ()
1101478

  • Self-care monitoring/reporting software
SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software
APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control
Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software
SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software
SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical
SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6102 AHCL APP 2.2 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000867638 ()


  • Self-care monitoring/reporting software
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