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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Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
P736025
Not in Commercial Distribution

  • 09321502034180 ()
P736025

  • Hearing aid/implant system remote control
Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
95448
Not in Commercial Distribution

  • 09321502034159 ()
95448

  • Hearing aid/implant system remote control
PUMP,REPLACEMENT,APP,AIRONE
MEDLINE INDUSTRIES, INC.
MSCAOPUMP
In Commercial Distribution

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006388 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


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

  • 00851203006173 ()


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

  • 00851203006128 ()


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

  • 00851203006111 ()


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

  • 00851203006036 ()


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

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

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

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.5.0 ANDROID
Sbo Hearing A/S
274910
In Commercial Distribution

  • 05714464146017 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.4.0 ANDROID
Sbo Hearing A/S
270494
In Commercial Distribution

  • 05714464139484 ()


  • Hearing aid/implant system remote control
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software
BERNAFON APP 1.3.0 ANDROID
Sbo Hearing A/S
269351
In Commercial Distribution

  • 05714464133918 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.2.0 ANDROID
Sbo Hearing A/S
265713
In Commercial Distribution

  • 05714464127221 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.1.0 ANDROID
Sbo Hearing A/S
264781
In Commercial Distribution

  • 05714464125159 ()


  • Hearing aid/implant system remote control
Bernafon App 1.0.0 Android
Sbo Hearing A/S
242481
In Commercial Distribution

  • 05714464058921 ()


  • Hearing aid/implant system remote control
APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system
Hearing Remote 5.0 app
Sonova AG
088-5017
In Commercial Distribution

  • 07613389610925 ()
088-5017

  • Audiometric/hearing device software
All-Day Clear 1.0 app
Sonova AG
088-5015
In Commercial Distribution

  • 07613389557930 ()
088-5015

  • Audiometric/hearing device software
TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer
Easy Line remote App
Sonova AG
088-0010
In Commercial Distribution

  • 07613389310962 ()
088-0010

  • Audiometric/hearing device software
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