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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FreeStyle LibreLink iOS US
ABBOTT DIABETES CARE INC
71733-01
In Commercial Distribution

  • 00357599000059 ()
71733-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
DreamMapper Application iOS (APAC)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041981 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance
Respironics, Inc.
DreamMapper iOS, China Instance - 2
Not in Commercial Distribution

  • 00606959057722 ()
1136968

  • Self-care monitoring/reporting software
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
On1 IOS Replica WP
Nobel Biocare AB
38742
Not in Commercial Distribution

  • 07332747176278 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
Not in Commercial Distribution

  • 07332747176261 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
Not in Commercial Distribution

  • 07332747176254 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747213072 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747213065 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747213058 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747113778 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747113754 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747113761 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
SAW ATTACHMENT/90 DEGREE ANGLED FOR EPD AND APD
Synthes GmbH
05.001.182
In Commercial Distribution

  • 07611819414778 ()
  • H679050011820 ()
  • 10886982129550 ()
05001182

  • Sawing power tool attachment, sagittal
ATTACHMENT TRAY ASSEMBLY F/MODULAR GRAPHIC CASE F/EPD
Synthes GmbH
690.588
In Commercial Distribution

  • H6796905880 ()
  • 10886982254801 ()
690588

  • Surgical instrument/implant rack
INSERT TRAY FOR SMALL BATTERY DRIVE ADAPTOR FOR EPD
Synthes GmbH
60.550.015
In Commercial Distribution

  • 10886982249098 ()
  • H679605500150 ()
60550015

  • Surgical instrument/implant rack
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control
APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control
APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control
APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control
APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control
APP TRUHEARING
Ws Audiology Usa, Inc.
TruHearing App
In Commercial Distribution

  • 05714880113150 ()
10996369

  • Hearing aid/implant system remote control
Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software
Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set
myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software
myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software
Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
PHILIPS HEARLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215186
In Commercial Distribution

  • 05714464004621 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215184
In Commercial Distribution

  • 05714464004607 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.1.0 IOS
Sbo Hearing A/S
215182
In Commercial Distribution

  • 05714464004584 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.3.0 iOS
Sbo Hearing A/S
228215
In Commercial Distribution

  • 05714464012992 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.3.0 iOS
Sbo Hearing A/S
228213
In Commercial Distribution

  • 05714464012978 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.3.0 iOS
Sbo Hearing A/S
228211
In Commercial Distribution

  • 05714464012954 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.4.0 IOS
Sbo Hearing A/S
270492
In Commercial Distribution

  • 05714464139460 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.5.0 IOS
Sbo Hearing A/S
274917
In Commercial Distribution

  • 05714464146086 ()


  • Hearing aid/implant system remote control
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