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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iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
QuicklyPro-APP is a medical software that supports healthcare professionals, in general the physiotherapist, in managing the rehabilitation plan; in detail, it allows the patient at home to view and perform the exercises assigned to him by the physiotherapist, at the end of the exercises the results obtained are recorded and sent to the QP-Rehab platform where the physiotherapist can consult them.
QUICKLYPRO SRL
1.1.2
In Commercial Distribution

  • 08056999860035 ()


  • Biomechanical function analysis/rehabilitation software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software
Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Libre Android App US
ABBOTT DIABETES CARE INC
78745-01
In Commercial Distribution

  • 00357599840006 ()
78745-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
No Description
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software
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
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
No Description
Nox Medical ehf.
NOX-NOXTURNAL_APP
Not in Commercial Distribution

  • 15694311110019 ()
536210

  • Sleep disorder interpretive software, professional-only
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
SW APP A620 DBS PATIENT APP V3.0 LK55
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000523329 ()


  • Multiple active implantable device programmer
SW APP A610 DBS CLINICIAN APP V4.0 LK54
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000523312 ()


  • Multiple active implantable device programmer
Duraloc OPTION CUP Enduron Liner LPW 28mmID 62, 64 OR 66mmOD
DEPUY INTERNATIONAL LTD
1599-23-062
In Commercial Distribution

  • 10603295065685 ()
159923062

  • Non-constrained polyethylene acetabular liner
Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer
Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer
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