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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REMOTEFIT 3.1.0 IOS
Sbo Hearing A/S
220351
In Commercial Distribution

  • 05714464006618 ()


  • Hearing aid/implant system remote control
HEARLINK 2.0 IOS
Sbo Hearing A/S
204546
In Commercial Distribution

  • 05714464002832 ()


  • Hearing aid/implant system remote control
HEARLINK 1.0 IOS
Sbo Hearing A/S
199530
In Commercial Distribution

  • 05714464000012 ()


  • Hearing aid/implant system remote control
Release 5.0 iOS
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838120266 ()


  • General-purpose ultrasound imaging system
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
CUPTIMIZE Advanced iOS
DEPUY (IRELAND)
4515-80-071
In Commercial Distribution

  • 10603295552109 ()
451580071

  • Orthopaedic stereotactic surgery system
Cuptimize for Ios
DEPUY ORTHOPAEDICS, INC.
451580054
In Commercial Distribution

  • 10603295551270 ()
451580054

  • Orthopaedic stereotactic surgery system
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43307
In Commercial Distribution

  • 09008737433079 ()


  • Audiometric/hearing device software
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41341
In Commercial Distribution

  • 09008737413415 ()


  • Audiometric/hearing device software
DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

  • Self-care monitoring/reporting software
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