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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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NX2ME APP - 00842289101883

No Description
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software

Libre App - 00357599841003

Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Libre App - 00357599840006

Libre Android App US
ABBOTT DIABETES CARE INC
78745-01
In Commercial Distribution

  • 00357599840006 ()
78745-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Patient App - 04035479180461

No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software

Grin App - D962GGA00001

No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software

iOptima APP - J00714000630631

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software

iChiropro APP - J00714000510511

iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered

otoTune app - 00850016231390

APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software

otoTune app - 00850016231383

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

  • 00850016231383 ()


  • Audiometric/hearing device software

AirMini app - 00619498222445

Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software
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