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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EASYCONTROL-A 2.1.0 IOS
Bernafon AG
214717
In Commercial Distribution

  • 05711584115879 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.0 IOS
Bernafon AG
204543
In Commercial Distribution

  • 05711584106570 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.10 IOS
Bernafon AG
199523
In Commercial Distribution

  • 05711584095515 ()


  • Hearing aid wireless-fitting computer-aided set
REMOTELINK 2.1.0 IOS
Lehiso A/S
214712
Not in Commercial Distribution

  • 05713708000214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.0 IOS
Lehiso A/S
204456
Not in Commercial Distribution

  • 05713708000177 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.10 IOS
Lehiso A/S
199527
Not in Commercial Distribution

  • 05713708000153 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.9 IOS
Lehiso A/S
189260
Not in Commercial Distribution

  • 05713708000115 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.8 IOS
Lehiso A/S
185784
Not in Commercial Distribution

  • 05713708000054 ()


  • 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
RemoteFit 3.4.0 iOS
Sbo Hearing A/S
236790
In Commercial Distribution

  • 05714464042487 ()


  • Hearing aid/implant system remote control
RemoteFit 3.3.0 iOS
Sbo Hearing A/S
228207
In Commercial Distribution

  • 05714464012916 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.5.0 IOS
Sbo Hearing A/S
228201
In Commercial Distribution

  • 05714464012855 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.4.0 IOS
Sbo Hearing A/S
226426
In Commercial Distribution

  • 05714464012039 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.3.0 IOS
Sbo Hearing A/S
220589
In Commercial Distribution

  • 05714464011261 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.3.0 IOS
Sbo Hearing A/S
220595
In Commercial Distribution

  • 05714464011193 ()


  • Hearing aid/implant system remote control
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
REMOTELINK 2.5.0 IOS
Sbo Hearing A/S
228195
In Commercial Distribution

  • 05714464012794 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.4.0 IOS
Sbo Hearing A/S
226433
In Commercial Distribution

  • 05714464012107 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.2 IOS
Oticon A/S
176636
In Commercial Distribution

  • 05707131328533 ()


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

  • 00884838120266 ()


  • General-purpose ultrasound imaging system
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • Mental health/function therapeutic software, screen-viewed
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