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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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
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
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
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
The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
Model E4
In Commercial Distribution

  • 00863609000303 ()


  • Electronic acoustic stethoscope
The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
E6
In Commercial Distribution

  • 00850010298016 ()


  • Electronic acoustic stethoscope
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
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