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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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Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software
APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
APP,GN SMARTAPP
Gn Hearing A/S
21607300
In Commercial Distribution

  • 05708296196746 ()


  • Hearing aid/implant system remote control
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

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

  • 00851074007255 ()
RX22773-002

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

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder
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