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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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
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
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
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software
myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software
Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer
IOS VMAX SERIES OPTION-ICU CART
VYAIRE MEDICAL, INC.
776268-103
In Commercial Distribution

  • 10190752164154 ()
776268-103

  • Neonatal/adult intensive-care ventilator
SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software
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
PHILIPS HEARLINK 2 1.5.0 IOS
Sbo Hearing A/S
274917
In Commercial Distribution

  • 05714464146086 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.4.0 IOS
Sbo Hearing A/S
270492
In Commercial Distribution

  • 05714464139460 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.3.0 IOS
Sbo Hearing A/S
269358
In Commercial Distribution

  • 05714464133987 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.3.0 iOS
Sbo Hearing A/S
228215
In Commercial Distribution

  • 05714464012992 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.3.0 iOS
Sbo Hearing A/S
228213
In Commercial Distribution

  • 05714464012978 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.3.0 iOS
Sbo Hearing A/S
228211
In Commercial Distribution

  • 05714464012954 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215186
In Commercial Distribution

  • 05714464004621 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215184
In Commercial Distribution

  • 05714464004607 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.1.0 IOS
Sbo Hearing A/S
215182
In Commercial Distribution

  • 05714464004584 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.4.0 iOS
Sbo Hearing A/S
234032
In Commercial Distribution

  • 05714464034659 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.4.0 iOS
Sbo Hearing A/S
234030
In Commercial Distribution

  • 05714464034635 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.4.0 iOS
Sbo Hearing A/S
234028
In Commercial Distribution

  • 05714464034611 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246112
In Commercial Distribution

  • 05714464059782 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246110
In Commercial Distribution

  • 05714464059768 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.5.0 IOS
Sbo Hearing A/S
246108
In Commercial Distribution

  • 05714464059744 ()


  • Hearing aid/implant system remote control
Philips HearLink 2 1.0.0 iOS
Sbo Hearing A/S
242488
In Commercial Distribution

  • 05714464058990 ()


  • Hearing aid/implant system remote control
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044401 ()
1128264

  • Self-care monitoring/reporting software
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
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
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042018 ()
1128264

  • Self-care monitoring/reporting software
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
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
DIVIDER KIT F/MODULE INSERT FOR EPD MODULAR GRAPHIC CASE
Synthes GmbH
690.578.04
In Commercial Distribution

  • H980690578040 ()
  • 10887587059860 ()
69057804

  • Surgical instrument/implant rack
IRRIGATION NOZZLE FOR EPD AND APD FOR USE WITH 05.001.183
Synthes GmbH
05.001.185
In Commercial Distribution

  • 07611819418516 ()
  • H679050011850 ()
  • 10886982129581 ()
05001185

  • Surgical power tool irrigation-control device
IRRIGATION NOZZLE FOR EPD AND APD FOR USE WITH 05.001.182
Synthes GmbH
05.001.184
In Commercial Distribution

  • 07611819414785 ()
  • H679050011840 ()
  • 10886982129574 ()
05001184

  • Surgical power tool irrigation-control device
INSERT TRAY FOR 60,000 RPM PEN FOR EPD GRAPHIC CASE
Synthes GmbH
690.583
In Commercial Distribution

  • H6796905830 ()
  • 10886982254757 ()
690583

  • Surgical instrument/implant rack
MODULE INSERT 2 COMPARTMENTS F/MODULAR GRAPHIC CASE F/EPD
Synthes GmbH
690.579
In Commercial Distribution

  • H6796905790 ()
  • 10886982254719 ()
690579

  • Surgical instrument/implant rack
MODULE INSERT 4 COMPARTMENTS F/MODULAR GRAPHIC CASE F/EPD
Synthes GmbH
690.578
In Commercial Distribution

  • H6796905780 ()
  • 10886982254702 ()
690578

  • Surgical instrument/implant rack
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840046 ()


  • Self-care monitoring/reporting software
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