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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Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder
Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software
MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder
Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer
Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • Audiometric/hearing device software
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
myPhonak 4.0 app
Sonova AG
088-0013-71
In Commercial Distribution

  • 07613389403190 ()
088-0013-71

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-83
In Commercial Distribution

  • 07613389403183 ()
088-0013-83

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-22
In Commercial Distribution

  • 07613389403176 ()
088-0013-22

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-09
In Commercial Distribution

  • 07613389403169 ()
088-0013-09

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-06
In Commercial Distribution

  • 07613389403152 ()
088-0013-06

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-14
In Commercial Distribution

  • 07613389403145 ()
088-0013-14

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-46
In Commercial Distribution

  • 07613389403138 ()
088-0013-46

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-26
In Commercial Distribution

  • 07613389403121 ()
088-0013-26

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-28
In Commercial Distribution

  • 07613389403114 ()
088-0013-28

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-12
In Commercial Distribution

  • 07613389403107 ()
088-0013-12

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-16
In Commercial Distribution

  • 07613389403091 ()
088-0013-16

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-10
In Commercial Distribution

  • 07613389403084 ()
088-0013-10

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-92
In Commercial Distribution

  • 07613389403077 ()
088-0013-92

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-19
In Commercial Distribution

  • 07613389403060 ()
088-0013-19

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-17
In Commercial Distribution

  • 07613389403053 ()
088-0013-17

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-25
In Commercial Distribution

  • 07613389403046 ()
088-0013-25

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-97
In Commercial Distribution

  • 07613389403039 ()
088-0013-97

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-05
In Commercial Distribution

  • 07613389403022 ()
088-0013-05

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-13
In Commercial Distribution

  • 07613389403015 ()
088-0013-13

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-27
In Commercial Distribution

  • 07613389403008 ()
088-0013-27

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-20
In Commercial Distribution

  • 07613389402995 ()
088-0013-20

  • Audiometric/hearing device software
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