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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Engage Android Rechargeable OTC Beige Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831788 ()
10080-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
SFTWR MMT-8401 1.1 CGM MODULE ANDROID US
MEDTRONIC MINIMED, INC.
MMT-8401
In Commercial Distribution

  • 00763000721367 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical
CIN Agar, 15x100mm Plate, 18ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources.
HARDY DIAGNOSTICS
G20
In Commercial Distribution

  • 00816576025244 ()
  • 00816576025251 ()
G20

  • Differential/selective agar culture medium IVD
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
Tala Android - OTC Hearing aid Ety part #20138
ETYMOTIC RESEARCH, INC.
Tala Android
In Commercial Distribution

  • 00846430005839 ()


  • Air-conduction hearing aid, in-the-ear
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software
DreamMapper Mobile App Android, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054233 ()
1128265

  • Self-care monitoring/reporting software
128 Ch Hearing Aid Universal for Android Beige
HEARING LAB TECHNOLOGY, LLC
5465
In Commercial Distribution

  • 00812944029715 ()
HLT-U128WLA-BG

  • Air-conduction hearing aid, receiver-in-the-ear
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00024
Not in Commercial Distribution

  • 03615220004294 ()


  • Electroencephalographic 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
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
A digital epilepsy care management platform application for Android.
Ai Nile Inc
Nile for Android
In Commercial Distribution

  • 00850031821019 ()


  • Medication reminder application software
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
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