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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EASYCONTROL-A 1.4 IOS
Bernafon AG
178496
In Commercial Distribution

  • 05711583029900 ()


  • Hearing aid/implant system remote control
BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
EASYCONTROL-A 2.1.0 IOS
Bernafon AG
214717
In Commercial Distribution

  • 05711584115879 ()


  • Hearing aid/implant system remote control
DreamMapper App iOS
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048560 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047525 ()
1101478

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

  • 00606959046740 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044340 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041943 ()
1101478

  • Self-care monitoring/reporting software
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
G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-003
In Commercial Distribution

  • 00864206000437 ()


  • Dental milling system, CAD/CAM, chairside
Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside
VeriPulse IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Veripulse IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
WHIP-MIX CORPORATION
70675
Not in Commercial Distribution

  • D040706751 ()


  • Dental milling system, CAD/CAM, chairside
iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
Cara i500 ios System
Kulzer GmbH
66081716
In Commercial Distribution

  • J014660817160 ()
66081716

  • Dental milling system, CAD/CAM, laboratory
Cara i500 ios scanner
Kulzer GmbH
66077970
In Commercial Distribution

  • J014660779700 ()
66077970

  • Dental milling system, CAD/CAM, laboratory
OTICON REMOTECARE 3.1.0 IOS
Sbo Hearing A/S
219643
In Commercial Distribution

  • 05714464006458 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215188
In Commercial Distribution

  • 05714464004645 ()


  • Hearing aid/implant system remote control
Oticon RemoteCare 3.3.0 iOS
Sbo Hearing A/S
228209
In Commercial Distribution

  • 05714464012930 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.3.0 iOS
Sbo Hearing A/S
228203
In Commercial Distribution

  • 05714464012879 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.5.0 IOS
Sbo Hearing A/S
228198
In Commercial Distribution

  • 05714464012824 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.5.0 IOS
Sbo Hearing A/S
228196
In Commercial Distribution

  • 05714464012800 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 IOS
Sbo Hearing A/S
228193
In Commercial Distribution

  • 05714464012770 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 IOS
Sbo Hearing A/S
226657
In Commercial Distribution

  • 05714464012275 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.4.0 IOS
Sbo Hearing A/S
226431
In Commercial Distribution

  • 05714464012084 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.4.0 IOS
Sbo Hearing A/S
226429
In Commercial Distribution

  • 05714464012060 ()


  • Hearing aid/implant system remote control
OTICON ON 2.3.0 IOS
Sbo Hearing A/S
224170
In Commercial Distribution

  • 05714464011612 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.3.0 IOS
Sbo Hearing A/S
220593
In Commercial Distribution

  • 05714464011308 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.3.0 IOS
Sbo Hearing A/S
220591
In Commercial Distribution

  • 05714464011285 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.1.0 IOS
Sbo Hearing A/S
214715
In Commercial Distribution

  • 05714464003617 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.5.0 IOS
Sbo Hearing A/S
274919
In Commercial Distribution

  • 05714464146109 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.5.0 IOS
Sbo Hearing A/S
274915
In Commercial Distribution

  • 05714464146062 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.5.0 IOS
Sbo Hearing A/S
274913
In Commercial Distribution

  • 05714464146048 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.5.0 IOS
Sbo Hearing A/S
274911
In Commercial Distribution

  • 05714464146024 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.4.0 IOS
Sbo Hearing A/S
270493
In Commercial Distribution

  • 05714464139477 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.4.0 IOS
Sbo Hearing A/S
270491
In Commercial Distribution

  • 05714464139453 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.4.0 IOS
Sbo Hearing A/S
270490
In Commercial Distribution

  • 05714464139446 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.4.0 IOS
Sbo Hearing A/S
270489
In Commercial Distribution

  • 05714464139439 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.5.0 IOS
Sbo Hearing A/S
247221
In Commercial Distribution

  • 05714464060313 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246114
In Commercial Distribution

  • 05714464059805 ()


  • Hearing aid/implant system remote control
Oticon Companion 1.0.0 iOS
Sbo Hearing A/S
243486
In Commercial Distribution

  • 05714464059331 ()


  • Hearing aid/implant system remote control
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