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

Show Filters

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 (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
An Android platform mobile application to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-09
In Commercial Distribution

  • 00850049194006 ()


  • Air-conduction hearing aid, receiver-in-canal
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)
Lifewatch
MCT 1L Patch-Universal Gateway-Verizon
In Commercial Distribution

  • 00850725007040 ()


  • Electrocardiography telemetric monitoring system transmitter
An Android mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-07
In Commercial Distribution

  • 00850049194020 ()


  • Air-conduction hearing aid, receiver-in-canal
Amplion phone application for the Android OS system used on smartphones, Version 2.4.0
AMPLION CLINICAL COMMUNICATIONS, INC.
S-APP-240-1
Not in Commercial Distribution

  • 00850016398741 ()
S-APP-240-1

  • Nurse call system
Amplion phone application for the Android OS system used on smartphones, Version 2.3.8
AMPLION CLINICAL COMMUNICATIONS, INC.
S-APP-238-1
Not in Commercial Distribution

  • 00850016398338 ()
S-APP-238-1

  • Nurse call system
Accelerate-OR CIN Kit; Each Kit Includes QuickSuite Kit, 20x29 Disposable Pillowcase (2), 4x60 Foam Positioning Strap and Disposable Microfiber Mop Head (2).
Bosma Enterprises
10-8020CIN
In Commercial Distribution

  • 10818634020380 ()
  • 00818634020383 ()
10-8020CIN

  • Operating room turnover kit
  • Surgical linen/cushion set
  • Limb/torso/head restraint, single-use
  • Basic pillowcase, single-use
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist Android
In Commercial Distribution

  • 00884838127449 ()
989803221541

  • Centralized patient monitor
No Description
Ouraring Inc.
Fertile Window Android
In Commercial Distribution

  • 06430060159983 ()


  • Menstrual cycle self-monitoring software
No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
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
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
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices.
Astellas Pharma Us, Inc.
Android (Version 1)
In Commercial Distribution

  • 00304692416447 ()
DIGI-002

  • Medication reminder application software
CIN Agar, 15x100 monoplate, 10/pk (Cefsulodin, Irgasan, Novobiocin) For the selective isolation of Yersinia enterocolitica and Aeromonas spp. Inoculate at room temperature.
HARDY DIAGNOSTICS
G220
Not in Commercial Distribution

  • 00816576025404 ()
  • 00816576025411 ()
G220

  • Differential/selective agar culture medium IVD
Compatible with GE, 3 Lead Grouped ECG lead wires,Pinch,AHA
APK Technology Co.,Ltd.
A3157-EL1-001
In Commercial Distribution

  • 06946725538869 ()


  • Electrocardiographic lead set, reusable
GE Apex Pro FH-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-190
In Commercial Distribution

  • 16946725590789 ()
  • 06946725529942 ()
  • 16946725590956 ()


  • Electrocardiographic lead set, reusable
< 1 ... 53 54 55 56 57 ... 73 >