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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SONIC SOUNDLINK 3 1.2.0 IOS
Sbo Hearing A/S
265708
In Commercial Distribution

  • 05714464127177 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.2.0 IOS
Sbo Hearing A/S
265706
In Commercial Distribution

  • 05714464127153 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 IOS
Sbo Hearing A/S
264788
In Commercial Distribution

  • 05714464125227 ()


  • Hearing aid/implant system remote control
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047532 ()
1128264

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

  • 00606959046818 ()
1128264

  • Self-care monitoring/reporting software
HFX 2.0 Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426021135 ()


  • Implantable electrical stimulation device management software
HFX iQ Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426020817 ()
PTA10043

  • Implantable electrical stimulation device management software
Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software
Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software
APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control
APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control
APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control
APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control
APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control
APP TRUHEARING
Ws Audiology Usa, Inc.
TruHearing App
In Commercial Distribution

  • 05714880113150 ()
10996369

  • Hearing aid/implant system remote control
Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set
myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software
myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software
X POWER TITANIUM BLACK H5/33
Power Dental U.S.A. Inc.
1203BT
In Commercial Distribution

  • D9431203BT0 ()
1203BT

  • Manual dental scaler, reusable
  • Dental excavator, reusable
SCALERS JACQUETTE H5/33 BLACK EDITION
Power Dental U.S.A. Inc.
1203B
In Commercial Distribution

  • D9431203B0 ()
1203B

  • Manual dental scaler, reusable
Hygienist Golden Scaler #3. H5/33
GoldenDent
GH3
In Commercial Distribution

  • 00850011211335 ()
GH3

  • Manual dental scaler, reusable
DULL H5 HYGIENIST/33 JACQUETTE SCALER
HU-FRIEDY MFG. CO., LLC
DSH5/33
In Commercial Distribution

  • 10889950046620 ()


  • Manual dental scaler, reusable
#36 GOLD FOIL KNIFE/H5 SCALER
HU-FRIEDY MFG. CO., LLC
GK5013
In Commercial Distribution

  • 10889950049447 ()
GK5013

  • Periodontal knife
#H5/33 DE Scaler, ResinEight Hdl
HU-FRIEDY MFG. CO., LLC
SH5/338
In Commercial Distribution

  • 10889950028220 ()


  • Manual dental scaler, reusable
#H5/33 DE Scaler, #7 Handle
HU-FRIEDY MFG. CO., LLC
SH5/337
In Commercial Distribution

  • 10889950028213 ()


  • Manual dental scaler, reusable
#H5/33 DE Scaler, Satin Steel
HU-FRIEDY MFG. CO., LLC
SH5/336
In Commercial Distribution

  • 10889950028206 ()


  • Manual dental scaler, reusable
H5 SCALER/FILLION EXPLO SS HDL
HU-FRIEDY MFG. CO., LLC
PI8105
In Commercial Distribution

  • 10889950083601 ()


  • Manual dental scaler, reusable
Ligature Picker/H5 Sickle, #41 Handle
HU-FRIEDY MFG. CO., LLC
PI7012
In Commercial Distribution

  • 10889950083380 ()
PI7012

  • Orthodontic ligature director
H5/PLG 153 Large #41 Handle
HU-FRIEDY MFG. CO., LLC
PI5665
In Commercial Distribution

  • 10889950083113 ()
PI5665

  • Orthodontic ligature director
#H5/LD1 LIGATURE DIRECTOR, SATIN STEEL
HU-FRIEDY MFG. CO., LLC
PI5292
In Commercial Distribution

  • 10889950082857 ()
PI5292

  • Orthodontic ligature director
H5 SE SCALER SATIN STEEL HANDLE
HU-FRIEDY MFG. CO., LLC
SH56
In Commercial Distribution

  • 10889950095895 ()


  • Manual dental scaler, reusable
SCALER H5/H4 SATIN STEEL HANDLE
HU-FRIEDY MFG. CO., LLC
SC7031
In Commercial Distribution

  • 10889950094133 ()


  • Manual dental scaler, reusable
#H5/NEB128 DE SCALER, #9 EVEREDGE
HU-FRIEDY MFG. CO., LLC
SC6691
In Commercial Distribution

  • 10889950093907 ()


  • Manual dental scaler, reusable
#H5/NEB128 DE SCALER, #8 HDL
HU-FRIEDY MFG. CO., LLC
SC66378
In Commercial Distribution

  • 10889950093730 ()


  • Manual dental scaler, reusable
#H5/GF21S SCALER DE, #7 HANDLE
HU-FRIEDY MFG. CO., LLC
SC6555
In Commercial Distribution

  • 10889950093570 ()


  • Manual dental scaler, reusable
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