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
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution

  • 00850031821002 ()


  • Medication reminder application software
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
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
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


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

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution

  • 90850018992452 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
TRANSFER ECHO FOR PRE-KOH TG W PLATFORM, INTRAORAL SCANBODY
SWEDEN & MARTINA SPA
A-TG-INT-CAMTRA-W
In Commercial Distribution

  • D7701214043 ()
A-TG-INT-CAMTRA-W

  • Dental implant/prosthesis surgical procedure kit
TRANSFER ECHO FOR PRE-KOH TG M PLATFORM, INTRAORAL SCANBODY
SWEDEN & MARTINA SPA
A-TG-INT-CAMTRA-M
In Commercial Distribution

  • D7701214033 ()
A-TG-INT-CAMTRA-M

  • Dental implant/prosthesis surgical procedure kit
Periodontal chisel # 13K/TG "Kirkland" COMFORT | SL | double ended
devemed GmbH
02-KL 13K-TG C
In Commercial Distribution

  • 04061644036561 ()


  • Orthopaedic chisel
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