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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Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DA
In Commercial Distribution

  • 05060396173721 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-D
In Commercial Distribution

  • 05060396173714 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DT
In Commercial Distribution

  • 05060396173486 ()


  • Otoacoustic emission system, battery-powered
Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer
Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
V1
In Commercial Distribution

  • 00860009869707 ()


  • Tremor transducer
OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DTA
In Commercial Distribution

  • 05060396173172 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DA
In Commercial Distribution

  • 05060396173158 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-TA
In Commercial Distribution

  • 05060396173141 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DT
In Commercial Distribution

  • 05060396173134 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DTA
In Commercial Distribution

  • 05060396173165 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.
tyromotion GmbH
3
In Commercial Distribution

  • 09120077180120 ()


  • Biomechanical function analysis/rehabilitation software
No Description
Stockert GmbH
S7032
Not in Commercial Distribution

  • 04260166370621 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Percutaneous radio-frequency ablation system generator
25x2pcs
VISGENEER, INC.
30G I
In Commercial Distribution

  • 04712558762342 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Blood lancet, single-use
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