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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Libre Android App US
ABBOTT DIABETES CARE INC
78745-01
In Commercial Distribution

  • 00357599840006 ()
78745-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software
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
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
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
Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application 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
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
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
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
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
No Description
Nox Medical ehf.
NOX-NOXTURNAL_APP
Not in Commercial Distribution

  • 15694311110019 ()
536210

  • Sleep disorder interpretive software, professional-only
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
Hearing Test Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149948 ()


  • Self-testing tone audiometer
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
DreamMapper iOS China Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057210 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057203 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057197 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057180 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS, China Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054295 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051362 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049963 ()
1136968

  • Self-care monitoring/reporting software
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software
DreamMapper iOS China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059078 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059061 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059054 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059047 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059801 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059795 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059788 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059771 ()
1101478

  • Self-care monitoring/reporting software
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
SFTWR MMT-6112 CP IOS V2.3.0 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000437787 ()


  • Patient health record information system application software
SFTWR MMT-6112 CP IOS V2.2.0 OUS
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000432645 ()


  • Patient health record information system application software
Sftwr MMT-6112 CP iOS 3.3.1 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000827304 ()


  • Patient health record information system application software
COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder
Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
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