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 Class Implantable

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Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution

  • 00300021109554 ()
MA9131001AM

  • Medication reminder application software
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Tura Inc.
K581 CIN 58
In Commercial Distribution

  • 00764724859848 ()

  • Width: 58 Millimeter


  • Spectacle frame
No Description
Tura Inc.
K583 CIN 56
In Commercial Distribution

  • 00764724859800 ()

  • Width: 56 Millimeter


  • Spectacle frame
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system
Smartphone add-on for the symptomatic treatment of insect bites with heat.
Kamedi GmbH
00003AN
In Commercial Distribution

  • 04262370293116 ()


  • Insect bite/sting hyperthermia device
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52047
In Commercial Distribution

  • 09008737520472 ()


  • Audiometric/hearing device software
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00024
Not in Commercial Distribution

  • 03615220004294 ()


  • Electroencephalographic monitoring system
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