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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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App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution

  • 00810096640130 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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
No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
Windows Desktop based APP used to control Evok 1600 OTE/BTE device. A USB Bluetooth dongle will be used as an interface between the software and device. Also, remote support will be available through the APP to user to help with programming changes to improve their hearing needs.
Persona Medical
Persona APP Desktop
In Commercial Distribution

  • 00851362008148 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS™ App
In Commercial Distribution

  • 04719878879965 ()


  • Radiological PACS software
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution

  • B786SBM2AA2100 ()
SBM2AA210

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system
IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Cardinal Health 200, LLC
68820
In Commercial Distribution

  • 50192253028827 ()
  • 10192253028829 ()

  • Total Volume: 60 Milliliter
68820-

  • Irrigation syringe
Spring-Wire Guide for use with Standard 30 cc and 40 cc Intra-Aortic Balloon Catheters
TELEFLEX INCORPORATED
IPN000220
In Commercial Distribution

  • 30801902026478 ()
  • 00801902026477 ()

  • Length: 175 Centimeter
  • Outer Diameter: 0.025 Inch
IAA-03270

  • Intra-aortic balloon catheter
Canister for Collection, Decantation and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans MEGA 1500
Not in Commercial Distribution

  • 00893398002271 ()

  • cc
3-TT-MEGA 1500

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 2000cc
Not in Commercial Distribution

  • 00893398002264 ()

  • cc
3-TT-FILTRON 2000

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 1000cc
Not in Commercial Distribution

  • 00893398002257 ()

  • cc
3-TT-FILTRON 1000

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 500cc
Not in Commercial Distribution

  • 00893398002240 ()

  • cc
3-TT-FILTRON 500

  • Surgical suction system collection container, single-use
Syringes for Collection, Decantation and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Syringe Fill 360
Not in Commercial Distribution

  • 00893398002233 ()

  • cc
3-TT-SFILL 360

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 250cc
Not in Commercial Distribution

  • 00893398002172 ()

  • cc
3-TT-FILTRON 250

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 100cc
Not in Commercial Distribution

  • 00893398002165 ()

  • cc
3-TT-FILTRON 100

  • Surgical suction system collection container, single-use
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
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
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
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
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
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