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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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iCare PATIENT2 - 06430033851104

iCare PATIENT2 (Android version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851104 ()


  • Medical equipment clinical data interfacing software

DreamMapper - 00606959047495

DreamMapper Mobile Application Android
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047495 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper - 00606959046757

DreamMapper Mobile Application Android
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046757 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper - 00606959044357

DreamMapper Mobile Application Android
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044357 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper - 00606959041950

DreamMapper Mobile Application Android
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041950 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper - 00606959057685

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

  • 00606959057685 ()
1136947

  • Self-care monitoring/reporting software

Libre App - 00357599840006

Libre Android App US
ABBOTT DIABETES CARE INC
78745-01
In Commercial Distribution

  • 00357599840006 ()
78745-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle LibreLink - 00357599000042

FreeStyle LibreLink Android US
ABBOTT DIABETES CARE INC
71732-01
In Commercial Distribution

  • 00357599000042 ()
71732-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

CIONIC - G345620000040

CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external

Vscan - 00840682147101

Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software

Lucid® - 00810068831481

Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

  • Air-conduction hearing aid, receiver-in-the-ear

Lucid® - 00810068831467

Engage Android OTC Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831467 ()
10092

  • Air-conduction hearing aid, receiver-in-the-ear

Lucid® - 00810068831399

Engage Android OTC Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831399 ()
10077

  • Air-conduction hearing aid, receiver-in-the-ear

Liberty® - 00810068830934

Custom ITC 128 Android
HEARING LAB TECHNOLOGY, LLC
ITC128-A
In Commercial Distribution

  • 00810068830934 ()
HLT-CUSITC128-A

  • Air-conduction hearing aid, canal

BioStamp nPoint™ - G012SW0027

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

BioStamp nPoint™ - G012SW0026

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

BioStamp nPoint™ - G012SW0025

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

Kintinuum™ - B493SW0042

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

BioStamp nPoint™ - B493SW0027

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

BioStamp nPoint™ - B493SW0026

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

BioStamp nPoint™ - B493SW0025

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

Biim Android App, P2.0 - 07090045490334

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 - 07090045490310

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 - 07090045490235

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 - 07090045490198

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, P1.2 - 07090045490150

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, P1.1 - 07090045490020

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

Lucid Audio - 00846430005938

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

Infinity External Hex System - 00614950004447

PROSTHETIC RETAIN SCREW 1.25MM F/CIN & UBIV STD ABUT 14TL TI6AL4VELI
ACE SURGICAL SUPPLY CO., INC.
19522002
In Commercial Distribution

  • 00614950004447 ()

  • Width: 1.25 Millimeter
19522002

  • Screw endosteal dental implant, one-piece

OC-Auto - 00816917021157

Personal Use Kit OC-Auto, Custom Kit for Cin Labs of Hawaii
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-SLHI
In Commercial Distribution

  • 00816917021157 ()


  • Faecal occult blood IVD, reagent

Lexie Hearing - 00850022464256

Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software

CareLink SmartSync™ Common Application - 00643169833715

SW M01G02 CARELINK SMARTSYNC ANDROID
MEDTRONIC, INC.
M01G02
In Commercial Distribution

  • 00643169833715 ()


  • Implantable cardiac device management application software

Widex - 05706069674729

Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software

Widex - 05706069673579

BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control

WIDEX - 05706069779714

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

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control

Cell Therapy 360 Wearable Tech V1 - 00851203006234

BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution

  • 00851203006234 ()


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

Sonic - 05714464127184

SONIC SOUNDLINK 3 1.2.0 ANDROID
Sbo Hearing A/S
265709
In Commercial Distribution

  • 05714464127184 ()


  • Hearing aid/implant system remote control

Philips - 05714464127160

PHILIPS HEARLINK 2 1.2.0 ANDROID
Sbo Hearing A/S
265707
In Commercial Distribution

  • 05714464127160 ()


  • Hearing aid/implant system remote control

Philips - 05714464125210

PHILIPS HEARLINK 2 1.1.0 ANDROID
Sbo Hearing A/S
264787
In Commercial Distribution

  • 05714464125210 ()


  • Hearing aid/implant system remote control

Philips - 05714464146079

PHILIPS HEARLINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274916
In Commercial Distribution

  • 05714464146079 ()


  • Hearing aid/implant system remote control

Philips - 05714464139514

PHILIPS HEARLINK 2 1.4.0 ANDROID
Sbo Hearing A/S
270497
In Commercial Distribution

  • 05714464139514 ()


  • Hearing aid/implant system remote control

Philips - 05714464133970

PHILIPS HEARLINK 2 1.3.0 ANDROID
Sbo Hearing A/S
269357
In Commercial Distribution

  • 05714464133970 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464012985

Bernafon EasyControl Connect 3.3.0 Android
Sbo Hearing A/S
228214
In Commercial Distribution

  • 05714464012985 ()


  • Hearing aid/implant system remote control

Sonic - 05714464012961

Sonic SoundLink Connect 3.3.0 Android
Sbo Hearing A/S
228212
In Commercial Distribution

  • 05714464012961 ()


  • Hearing aid/implant system remote control

Philips - 05714464012947

Philips HearLink Connect 3.3.0 Android
Sbo Hearing A/S
228210
In Commercial Distribution

  • 05714464012947 ()


  • Hearing aid/implant system remote control

Philips - 05714464004614

PHILIPS HEARLINK CONNECT 3.1.0 ANDROID
Sbo Hearing A/S
215185
In Commercial Distribution

  • 05714464004614 ()


  • Hearing aid/implant system remote control

Sonic - 05714464004591

SONIC SOUNDLINK CONNECT 3.1.0 ANDROID
Sbo Hearing A/S
215183
In Commercial Distribution

  • 05714464004591 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464004577

BERNAFON EASYCONTROL CONNECT 3.1.0 ANDROID
Sbo Hearing A/S
215181
In Commercial Distribution

  • 05714464004577 ()


  • Hearing aid/implant system remote control

Philips - 05714464034642

Philips HearLink Connect 3.4.0 Android
Sbo Hearing A/S
234031
In Commercial Distribution

  • 05714464034642 ()


  • Hearing aid/implant system remote control

Sonic - 05714464034628

Sonic SoundLink Connect 3.4.0 Android
Sbo Hearing A/S
234029
In Commercial Distribution

  • 05714464034628 ()


  • Hearing aid/implant system remote control
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