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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 Size Type Device Class Implantable

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Philips Sonicare - 08710103988984

Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush

Hearing Help Express - 00858177007335

Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software

hiHealth Innovations - 00858177007144

Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software

AMI - 00851074007231

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007224

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder

Cardiostaff - 00851074007170

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder

Dexcom G7 Android App - 00386270001870

G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Onduo - 00860000249539

Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software

Widex - 05706069599985

COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

RXEars - 00851362008025

IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear

OvuSense - 05060508530114

OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser

Bionic Circle App, Android - 00850050080176

Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display

Cochlear - 09321502046145

Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software

TempTraq® - 00851203006432

TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


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

TempTraq® - 00851203006364

TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


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

TempTraq® - 00851203006128

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® - 00851203006111

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 - 00851203006036

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

Sirona - 00851074007149

Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder

Widex - 05706069930320

Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
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