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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APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
Periodontal chisel # 13K/TG "Kirkland" F-LINE | SL | double ended
devemed GmbH
KL 13K-TG F
In Commercial Distribution

  • 04061644022250 ()


  • Orthopaedic chisel
Periodontal chisel # 13K/TG "Kirkland" COMFORT | SL | double ended
devemed GmbH
02-KL 13K-TG C
In Commercial Distribution

  • 04061644036561 ()


  • Orthopaedic chisel
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Titan Design 4.8mm Tg Hex Abutment Plastic Sleeve Non-Hex
TITAN IMPLANT INC
TN-48TGIAPSNH
In Commercial Distribution

  • 00842448112361 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Titan Design 4.8mm Tg Hex Abutment Plastic Sleeve Hex
TITAN IMPLANT INC
TN-48TGIAPSH
In Commercial Distribution

  • 00842448112354 ()


  • Dental implant suprastructure, temporary, preformed, single-use
XiVE® TG Lab Set Implant-/Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259306
Not in Commercial Distribution

  • EFRI322593062 ()
25-9306

  • Dental implant suprastructure kit
XiVE® TG Lab Set Implant-/Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259305
Not in Commercial Distribution

  • EFRI322593052 ()
25-9305

  • Dental implant suprastructure kit
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