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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iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software
myAir (iOS)
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
This DI information is for the EzDebride Shipper containing 80 devices
Mdm Wound Ventures Inc.
EZ-001
In Commercial Distribution

  • 10860010005917 ()
  • 00860010005903 ()


  • Wound debridement tool
EzDebride Carton containing 8 EzDebride devices, unit of use.
Mdm Wound Ventures Inc.
EZ-001
In Commercial Distribution

  • 00860010005903 ()
  • 00860010005910 ()


  • Wound debridement tool
BAG TEE ASSY-DIGITAL MDM
PARKER-HANNIFIN CORPORATION
30157400
In Commercial Distribution

  • 00816711020783 ()
30157400

  • Non-rebreathing valve, reusable
Specialty MDM Expandable Coupler
Howmedica Osteonics Corp.
I-H1956HA00
In Commercial Distribution

  • 07613327299847 ()

  • Diameter: 38.0 Millimeter
I-H1956HA00

  • Orthopaedic prosthesis implantation positioning instrument, reusable
MDM MONOPOLAR TRIAL INSERT
Howmedica Osteonics Corp.
1235-0-244M
In Commercial Distribution

  • 07613327195804 ()

  • Lumen/Inner Diameter: 22.2 Millimeter
  • Alpha Code: D
  • Outer Diameter: 38.0 Millimeter
1235-0-244M

  • Femoral head prosthesis trial
MDM MONOPOLAR TRIAL INSERT
Howmedica Osteonics Corp.
1235-0-242M
In Commercial Distribution

  • 07613327195576 ()

  • Alpha Code: C
  • Lumen/Inner Diameter: 22.2 Millimeter
  • Outer Diameter: 36.0 Millimeter
1235-0-242M

  • Femoral head prosthesis trial
MDM MONOPOLAR TRIAL INSERT
Howmedica Osteonics Corp.
1235-0-844M
In Commercial Distribution

  • 07613327605471 ()

  • Outer Diameter: 38.0 Millimeter
  • Alpha Code: D
  • Lumen/Inner Diameter: 28.0 Millimeter
1235-0-844M

  • Femoral head prosthesis trial
CROS,SUREFIT,EUROPLUG,MDM
Gn Hearing A/S
20040600
In Commercial Distribution

  • 05708296137190 ()


  • Contralateral hearing unit
SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
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
iOS
In Commercial Distribution

  • 04260749840039 ()


  • Self-care monitoring/reporting software
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. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
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
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.
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
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
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
EASYCONTROL-A 1.8 IOS
Bernafon AG
185786
In Commercial Distribution

  • 05711584083192 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.9 IOS
Oticon A/S
189254
In Commercial Distribution

  • 05711584085332 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.1.0 IOS
Bernafon AG
214717
In Commercial Distribution

  • 05711584115879 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.4 IOS
Bernafon AG
178496
In Commercial Distribution

  • 05711583029900 ()


  • 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
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
REMOTELINK 2.4.0 IOS
Sbo Hearing A/S
226433
In Commercial Distribution

  • 05714464012107 ()


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

  • 05714464042487 ()


  • Hearing aid/implant system remote control
REMOTEFIT 3.5.0 IOS
Sbo Hearing A/S
247219
In Commercial Distribution

  • 05714464060290 ()


  • 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
REMOTELINK 2.5.0 IOS
Sbo Hearing A/S
228195
In Commercial Distribution

  • 05714464012794 ()


  • 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
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