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

Show Filters

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-5502-01-300
Not in Commercial Distribution

  • 00817491023612 ()
FG-5502-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution

  • 00817491023490 ()
FG-5902-01-300

  • Implantable glucose monitoring system
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-5502-01-300
Not in Commercial Distribution

  • 00817491022387 ()
FG-5502-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14116
In Commercial Distribution

  • 00386270004635 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321759 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution

  • 08052990321636 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321124 ()
911105

  • Expiratory peak flow meter, digital
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Black
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000813 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - White
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000806 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000790 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Red
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000783 ()


  • Room humidifier
DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020000 ()


  • Endoscopic video image processing unit
HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution

  • 08719425505121 ()


  • Dental appliance fabrication material, resin
Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7225-05
In Commercial Distribution

  • 00840199507528 ()
  • 10840199507525 ()

  • 9x12mm
7225-05

  • Soft-tissue surgical hook, reusable
< 1 ... 35 36 37 38 39 ... 120 >