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

Show Filters

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
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9308
In Commercial Distribution

  • 09348215045753 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Non-constrained polyethylene acetabular liner
25x2pcs
VISGENEER, INC.
30G I
In Commercial Distribution

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

  • Blood lancet, single-use
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
< 1 ... 214 215 216 217 218 ... 227 >