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 1.4.0 IOS
Sbo Hearing A/S
270492
In Commercial Distribution

  • 05714464139460 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK 3 1.2.0 IOS
Sbo Hearing A/S
265708
In Commercial Distribution

  • 05714464127177 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.2.0 IOS
Sbo Hearing A/S
265706
In Commercial Distribution

  • 05714464127153 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 IOS
Sbo Hearing A/S
264788
In Commercial Distribution

  • 05714464125227 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.4.0 iOS
Sbo Hearing A/S
234032
In Commercial Distribution

  • 05714464034659 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.4.0 iOS
Sbo Hearing A/S
234030
In Commercial Distribution

  • 05714464034635 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.4.0 iOS
Sbo Hearing A/S
234028
In Commercial Distribution

  • 05714464034611 ()


  • Hearing aid/implant system remote control
FW updater App 1.0.0 iOS
Sbo Hearing A/S
232872
In Commercial Distribution

  • 05714464033829 ()


  • Hearing aid wireless-fitting computer-aided set
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
BERNAFON EASYCONTROL CONNECT 3.5.0 IOS
Sbo Hearing A/S
246108
In Commercial Distribution

  • 05714464059744 ()


  • Hearing aid/implant system remote control
Philips HearLink 2 1.0.0 iOS
Sbo Hearing A/S
242488
In Commercial Distribution

  • 05714464058990 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.3.0 iOS
Sbo Hearing A/S
228215
In Commercial Distribution

  • 05714464012992 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.3.0 iOS
Sbo Hearing A/S
228213
In Commercial Distribution

  • 05714464012978 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.3.0 iOS
Sbo Hearing A/S
228211
In Commercial Distribution

  • 05714464012954 ()


  • 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
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,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,IOS
Gn Hearing A/S
20409500
In Commercial Distribution

  • 05708296071432 ()


  • 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,KS DISCOVER,1.4,IOS
Gn Hearing A/S
20665200
In Commercial Distribution

  • 05708296164295 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,IOS
Gn Hearing A/S
20993600
In Commercial Distribution

  • 05708296158461 ()


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

  • 05708296214662 ()


  • 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
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • 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
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
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
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