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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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NA - 05415067034960

Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer

SJM™ - 05415067023810

Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer

SJM™ - 05415067023803

Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer

hear.com - 05714880113228

APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control

CONNEXX - 05714880187229

APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution

  • 05714880187229 ()
21023158

  • Audiometric/hearing device software

Viewfinder remote app - 00690103215847

Viewfinder remote app
Edwards Lifesciences LLC
VFREM
In Commercial Distribution

  • 00690103215847 ()
VFREM

  • Bedside monitor remote-viewing software, physiological parameter
  • General-purpose multi-parameter bedside monitor

Onduo - 00860000249539

Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software

Onduo - 00860000249522

Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software

GN Hearing - 05708296196746

APP,GN SMARTAPP
Gn Hearing A/S
21607300
In Commercial Distribution

  • 05708296196746 ()


  • Hearing aid/implant system remote control

NeuroSphere™ - 05415067050311

Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer

SmartView - 08031527019932

SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software

Eloquence - 00816486021237

Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer

PRC-Saltillo - 00816486021183

Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer

Saltillo - 00816486021053

TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer

Saltillo - 00816486021022

Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer

Sonova Brand - 07613389477283

myPhonak Junior app
Sonova AG
088-0017
In Commercial Distribution

  • 07613389477283 ()
088-0017

  • Audiometric/hearing device software

Sonova Brand - 07613389477191

myPhonak Junior app
Sonova AG
088-0017-71
In Commercial Distribution

  • 07613389477191 ()
088-0017-71

  • Audiometric/hearing device software

Sonova Brand - 07613389477184

myPhonak Junior app
Sonova AG
088-0017-83
In Commercial Distribution

  • 07613389477184 ()
088-0017-83

  • Audiometric/hearing device software

Sonova Brand - 07613389477177

myPhonak Junior app
Sonova AG
088-0017-22
In Commercial Distribution

  • 07613389477177 ()
088-0017-22

  • Audiometric/hearing device software

Sonova Brand - 07613389477160

myPhonak Junior app
Sonova AG
088-0017-09
In Commercial Distribution

  • 07613389477160 ()
088-0017-09

  • Audiometric/hearing device software

Sonova Brand - 07613389477153

myPhonak Junior app
Sonova AG
088-0017-06
In Commercial Distribution

  • 07613389477153 ()
088-0017-06

  • Audiometric/hearing device software

Sonova Brand - 07613389477146

myPhonak Junior app
Sonova AG
088-0017-14
In Commercial Distribution

  • 07613389477146 ()
088-0017-14

  • Audiometric/hearing device software

Sonova Brand - 07613389477139

myPhonak Junior app
Sonova AG
088-0017-46
In Commercial Distribution

  • 07613389477139 ()
088-0017-46

  • Audiometric/hearing device software

Sonova Brand - 07613389477122

myPhonak Junior app
Sonova AG
088-0017-26
In Commercial Distribution

  • 07613389477122 ()
088-0017-26

  • Audiometric/hearing device software

Sonova Brand - 07613389477115

myPhonak Junior app
Sonova AG
088-0017-28
In Commercial Distribution

  • 07613389477115 ()
088-0017-28

  • Audiometric/hearing device software

Sonova Brand - 07613389477108

myPhonak Junior app
Sonova AG
088-0017-12
In Commercial Distribution

  • 07613389477108 ()
088-0017-12

  • Audiometric/hearing device software

Sonova Brand - 07613389477092

myPhonak Junior app
Sonova AG
088-0017-16
In Commercial Distribution

  • 07613389477092 ()
088-0017-16

  • Audiometric/hearing device software

Sonova Brand - 07613389477085

myPhonak Junior app
Sonova AG
088-0017-10
In Commercial Distribution

  • 07613389477085 ()
088-0017-10

  • Audiometric/hearing device software

Sonova Brand - 07613389477078

myPhonak Junior app
Sonova AG
088-0017-92
In Commercial Distribution

  • 07613389477078 ()
088-0017-92

  • Audiometric/hearing device software

Sonova Brand - 07613389477061

myPhonak Junior app
Sonova AG
088-0017-19
In Commercial Distribution

  • 07613389477061 ()
088-0017-19

  • Audiometric/hearing device software

Sonova Brand - 07613389477054

myPhonak Junior app
Sonova AG
088-0017-17
In Commercial Distribution

  • 07613389477054 ()
088-0017-17

  • Audiometric/hearing device software

Sonova Brand - 07613389477047

myPhonak Junior app
Sonova AG
088-0017-25
In Commercial Distribution

  • 07613389477047 ()
088-0017-25

  • Audiometric/hearing device software

Sonova Brand - 07613389477030

myPhonak Junior app
Sonova AG
088-0017-97
In Commercial Distribution

  • 07613389477030 ()
088-0017-97

  • Audiometric/hearing device software

Sonova Brand - 07613389477023

myPhonak Junior app
Sonova AG
088-0017-05
In Commercial Distribution

  • 07613389477023 ()
088-0017-05

  • Audiometric/hearing device software

Sonova Brand - 07613389477016

myPhonak Junior app
Sonova AG
088-0017-13
In Commercial Distribution

  • 07613389477016 ()
088-0017-13

  • Audiometric/hearing device software

Sonova Brand - 07613389477009

myPhonak Junior app
Sonova AG
088-0017-27
In Commercial Distribution

  • 07613389477009 ()
088-0017-27

  • Audiometric/hearing device software

Sonova Brand - 07613389476996

myPhonak Junior app
Sonova AG
088-0017-20
In Commercial Distribution

  • 07613389476996 ()
088-0017-20

  • Audiometric/hearing device software

Sonova Brand - 07613389476989

myPhonak Junior app
Sonova AG
088-0017-01
In Commercial Distribution

  • 07613389476989 ()
088-0017-01

  • Audiometric/hearing device software

Sonova Brand - 07613389476972

myPhonak Junior app
Sonova AG
088-0017-04
In Commercial Distribution

  • 07613389476972 ()
088-0017-04

  • Audiometric/hearing device software

Sonova Brand - 07613389476965

myPhonak Junior app
Sonova AG
088-0017-11
In Commercial Distribution

  • 07613389476965 ()
088-0017-11

  • Audiometric/hearing device software

Sonova Brand - 07613389476958

myPhonak Junior app
Sonova AG
088-0017-02
In Commercial Distribution

  • 07613389476958 ()
088-0017-02

  • Audiometric/hearing device software

Sonova Brand - 07613389476941

myPhonak Junior app
Sonova AG
088-0017-07
In Commercial Distribution

  • 07613389476941 ()
088-0017-07

  • Audiometric/hearing device software

Sonova Brand - 07613389476934

myPhonak Junior app
Sonova AG
088-0017-08
In Commercial Distribution

  • 07613389476934 ()
088-0017-08

  • Audiometric/hearing device software

Sonova Brand - 07613389476927

myPhonak Junior app
Sonova AG
088-0017-45
In Commercial Distribution

  • 07613389476927 ()
088-0017-45

  • Audiometric/hearing device software

Sonova Brand - 07613389476910

myPhonak Junior app
Sonova AG
088-0017-15
In Commercial Distribution

  • 07613389476910 ()
088-0017-15

  • Audiometric/hearing device software

Sonova Brand - 07613389475203

myPhonak Junior app
Sonova AG
088-0017-44
In Commercial Distribution

  • 07613389475203 ()
088-0017-44

  • Audiometric/hearing device software

Sonova Brand - 07613389475197

myPhonak Junior app
Sonova AG
088-0017-70
In Commercial Distribution

  • 07613389475197 ()
088-0017-70

  • Audiometric/hearing device software

Sonova Brand - 07613389475180

myPhonak Junior app
Sonova AG
088-0017-24
In Commercial Distribution

  • 07613389475180 ()
088-0017-24

  • Audiometric/hearing device software

Sonova Brand - 07613389475173

myPhonak Junior app
Sonova AG
088-0017-21
In Commercial Distribution

  • 07613389475173 ()
088-0017-21

  • Audiometric/hearing device software

Unitron - 07613389444391

HelloGo Hearing App
Unitron Hearing Division
088-5012
In Commercial Distribution

  • 07613389444391 ()
088-5012

  • Audiometric/hearing device software
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