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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DreamMapper Android China Instance
Respironics, Inc.
DreamMapper Android, China Instance - 2
Not in Commercial Distribution

  • 00606959057685 ()
1136947

  • Self-care monitoring/reporting software
Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
DreamMapper Mobile Application Android
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044357 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041950 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047495 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046757 ()
1101479

  • Self-care monitoring/reporting software
TALA Android EARPIECE RIGHT
ETYMOTIC RESEARCH, INC.
TALA ANDROID EARP R
In Commercial Distribution

  • 00846430005853 ()


  • Air-conduction hearing aid, in-the-ear
TALA Android EARPIECE LEFT
ETYMOTIC RESEARCH, INC.
TALA ANDROID EARP L
In Commercial Distribution

  • 00846430005846 ()


  • Air-conduction hearing aid, in-the-ear
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
Investigator application for Android
Medidata Solutions, Inc.
SW-0027
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
Medidata Solutions, Inc.
SW-0026
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
Medidata Solutions, Inc.
SW-0025
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software
Patient application for Android
MC10, INC.
SW-0042
Not in Commercial Distribution

  • B493SW0042 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Investigator application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0027 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0026 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
MC10, INC.
SW-0025
Not in Commercial Distribution

  • B493SW0025 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831467 ()
10092

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831399 ()
10077

  • Air-conduction hearing aid, receiver-in-the-ear
Custom ITC 128 Android
HEARING LAB TECHNOLOGY, LLC
ITC128-A
In Commercial Distribution

  • 00810068830934 ()
HLT-CUSITC128-A

  • Air-conduction hearing aid, canal
Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P2.0
Biim Ultrasound AS
P001425
In Commercial Distribution

  • 07090045490334 ()
P001425

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
Biim Android App, P1.3.2
Biim Ultrasound AS
P001418
In Commercial Distribution

  • 07090045490310 ()
P001418

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3.1
Biim Ultrasound AS
P001403
In Commercial Distribution

  • 07090045490235 ()
P001403

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3
Biim Ultrasound AS
P001228
In Commercial Distribution

  • 07090045490198 ()
P001228

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Renew Android White 64 channel #20183 Renew Bluetooth Rechargeable 3401 - Android WH
ETYMOTIC RESEARCH, INC.
Renew Android White
In Commercial Distribution

  • 00846430005938 ()


  • Air-conduction hearing aid, in-the-ear
PHILIPS HEARLINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274916
In Commercial Distribution

  • 05714464146079 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.4.0 ANDROID
Sbo Hearing A/S
270497
In Commercial Distribution

  • 05714464139514 ()


  • Hearing aid/implant system remote control
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