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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APP,BT SMART REMOTE,1.0.6,IOS
Gn Hearing A/S
20409600
In Commercial Distribution

  • 05708296071494 ()


  • 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
SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
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
Sftwr MMT-6102 AHCL 2.1.1 App iOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000827793 ()


  • Self-care monitoring/reporting software
Sftwr MMT-6112 CP iOS 3.3.1 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000827304 ()


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

  • 00763000943264 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • 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
SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6112 CP IOS V2.3.0 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000437787 ()


  • Patient health record information system application software
SFTWR MMT-6112 CP IOS V2.2.0 OUS
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000432645 ()


  • Patient health record information system application software
SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software
SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical
Stand alone software used to collect, store and print patient data on various iOS devices
Zoll Medical Corporation
ZEPCRU
In Commercial Distribution

  • 00847946021924 ()


  • Medical equipment clinical data interfacing software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
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