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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SCALER #H5/33
J & J INSTRUMENTS INC
11-533
In Commercial Distribution

  • 00817524024234 ()


  • Manual dental scaler, reusable
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
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
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
EASYCONTROL-A 1.4 IOS
Bernafon AG
178496
In Commercial Distribution

  • 05711583029900 ()


  • 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 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
EASYCONTROL-A 1.9 IOS
Oticon A/S
189254
In Commercial Distribution

  • 05711584085332 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.8 IOS
Bernafon AG
185786
In Commercial Distribution

  • 05711584083192 ()


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

  • 05707131328533 ()


  • 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 3.3.0 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
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
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
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
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
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 Application iOS
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041943 ()
1101478

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

  • 00606959044340 ()
1101478

  • Self-care monitoring/reporting 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
Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital
PLUGGER 2.7mm/SCALER H5
Power Dental U.S.A. Inc.
5898
In Commercial Distribution

  • D94358980 ()
5898

  • Manual dental scaler, reusable
  • Dental excavator, reusable
SCALERS TOWNER H5/U15
Power Dental U.S.A. Inc.
1202
In Commercial Distribution

  • D94312020 ()
1202

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

  • D94312030 ()
1203

  • Dental excavator, reusable
  • Manual dental scaler, reusable
Dull Scaler H5/L4
HU-FRIEDY MFG. CO., LLC
DSH5/L46
In Commercial Distribution

  • 10889950106171 ()


  • Manual dental scaler, reusable
#H5/NEB128 Scaler EE2
HU-FRIEDY MFG. CO., LLC
SC6691E2
In Commercial Distribution

  • 10889950103323 ()


  • Periodontal curette
#H5/GF21S SCALER DE
HU-FRIEDY MFG. CO., LLC
SC1393
In Commercial Distribution

  • 10889950091187 ()


  • Manual dental scaler, reusable
#H5/U15 DE Scaler
HU-FRIEDY MFG. CO., LLC
SH5/U15
In Commercial Distribution

  • 10889950028275 ()


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

  • 10889950028183 ()


  • Manual dental scaler, reusable
ROI-C IMPLANT 12X15.5 H5
LDR Spine Usa, Inc.
MC1351P
In Commercial Distribution

  • 03662663016346 ()

  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C IMPLANT 12X14 H5
LDR Spine Usa, Inc.
MC1341P
In Commercial Distribution

  • 03662663016278 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
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