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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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
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SET S.BLOCK N. IBS MAGICORE ø 4 h5
In Commercial Distribution

  • 08059224200613 ()
002IB45R

  • Dental implant suprastructure, permanent, preformed
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SET S.BLOCK M. ASTRA EV ø 4.8 h5
In Commercial Distribution

  • 08059224147666 ()
003AEV485R

  • Dental implant suprastructure, permanent, preformed
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SET S.BLOCK M. ASTRA ACQUA ø 3.5-4 h5
In Commercial Distribution

  • 08059224039954 ()
003AOA5R

  • Dental implant suprastructure, permanent, preformed
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
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