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

Show Filters

DOME,SF,PWR,MDM,BAG,10 PCS
Gn Hearing A/S
19398700
In Commercial Distribution

  • 05708296140039 ()


  • Earmould, preformed
DOME,SF,PWR,MDM,BAG,1 PCS
Gn Hearing A/S
21417100
In Commercial Distribution

  • 05708296191741 ()


  • Earmould, preformed
DOME,SF,OPEN,MDM,BAG,1 PCS
Gn Hearing A/S
21416700
In Commercial Distribution

  • 05708296191703 ()


  • Earmould, preformed
DOME,THNTUB/REC,SZ7,MDM,BAG,1
Gn Hearing A/S
21414500
In Commercial Distribution

  • 05708296191666 ()


  • Earmould, preformed
DOME,THNTUB/REC,PWR,MDM,BAG,1
Gn Hearing A/S
21414200
In Commercial Distribution

  • 05708296191635 ()


  • Earmould, preformed
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management 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
DreamMapper Mobile iOS China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059801 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059795 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059788 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059771 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059078 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059061 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059054 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059047 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057210 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057203 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057197 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057180 ()
1101478

  • Self-care monitoring/reporting software
Hearing Test Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149948 ()


  • Self-testing tone audiometer
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software
Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
DreamMapper iOS, China Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054295 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051362 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051355 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051348 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051331 ()
1101478

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

  • 00606959049963 ()
1136968

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

  • 00606959049956 ()
1127959

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

  • 00606959049949 ()
1128264

  • 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 APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049109 ()
1127959

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

  • 00606959049093 ()
1128264

  • 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
APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control
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
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
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 2.7 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
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-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
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