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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OTICON COMPANION 1.3.0 IOS
Sbo Hearing A/S
269348
In Commercial Distribution

  • 05714464133888 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.2.0 IOS
Sbo Hearing A/S
265712
In Commercial Distribution

  • 05714464127214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.2.0 IOS
Sbo Hearing A/S
265710
In Commercial Distribution

  • 05714464127191 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.2.0 IOS
Sbo Hearing A/S
265702
In Commercial Distribution

  • 05714464127139 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.1.0 IOS
Sbo Hearing A/S
264790
In Commercial Distribution

  • 05714464125241 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.1.0 IOS
Sbo Hearing A/S
264786
In Commercial Distribution

  • 05714464125203 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.1.0 IOS
Sbo Hearing A/S
264784
In Commercial Distribution

  • 05714464125180 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.1.0 IOS
Sbo Hearing A/S
264782
In Commercial Distribution

  • 05714464125166 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.1.0 IOS
Sbo Hearing A/S
219643
In Commercial Distribution

  • 05714464006458 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 IOS
Sbo Hearing A/S
228193
In Commercial Distribution

  • 05714464012770 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 IOS
Sbo Hearing A/S
226657
In Commercial Distribution

  • 05714464012275 ()


  • Hearing aid/implant system remote control
iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
OTICON ON 2.1.0 IOS
Oticon A/S
219645
In Commercial Distribution

  • 05707131395474 ()


  • Hearing aid/implant system remote control
OTICON ON 2.0 IOS
Oticon A/S
204454
In Commercial Distribution

  • 05707131357601 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.0 IOS
Oticon A/S
204452
In Commercial Distribution

  • 05707131357588 ()


  • Hearing aid/implant system remote control
REMOTE CARE 2.0 IOS
Oticon A/S
199529
In Commercial Distribution

  • 05707131349231 ()


  • Hearing aid/implant system remote control
OTICON ON 1.10 IOS
Oticon A/S
199520
In Commercial Distribution

  • 05707131349224 ()


  • Hearing aid/implant system remote control
REMOTE CARE 1.0 IOS
Oticon A/S
193798
In Commercial Distribution

  • 05707131343932 ()


  • Hearing aid/implant system remote control
TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006371 ()


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

  • 00851203006142 ()


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

  • 00851203006135 ()


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

  • 00851203006043 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
OTICON ON 1.4 IOS
Oticon A/S
178493
In Commercial Distribution

  • 05707131329981 ()


  • Hearing aid/implant system remote control
ON APP 1.2 IOS
Oticon A/S
176634
In Commercial Distribution

  • 05707131328519 ()


  • Hearing aid/implant system remote control
OTICON ON 1.9 IOS
Bernafon AG
189258
In Commercial Distribution

  • 05707131337351 ()


  • Hearing aid/implant system remote control
OTICON ON 1.8 IOS
Oticon A/S
185783
In Commercial Distribution

  • 05707131335074 ()


  • Hearing aid/implant system remote control
Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control
Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software
DreamMapper App iOS (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048584 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
DreamMapper App iOS, Asia-Pacific Instance - 2
In Commercial Distribution

  • 00606959057715 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance
Respironics, Inc.
DreamMapper iOS, China Instance - 2
Not in Commercial Distribution

  • 00606959057722 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper App iOS (EMEA)
Respironics, Inc.
DreamMapper Mobile App iOS EMEA - 2
In Commercial Distribution

  • 00606959057708 ()
1128264

  • Self-care monitoring/reporting software
Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
DreamMapper App iOS (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048577 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047549 ()
1127959

  • Self-care monitoring/reporting software
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