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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SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
SFTWR MMT-8400 1.1 CGM MODULE IOS US
MEDTRONIC MINIMED, INC.
MMT-8400
In Commercial Distribution

  • 00763000721350 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747113747 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747113730 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747113723 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747113716 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747113709 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747113693 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747191875 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747191868 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747191851 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747191844 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747191837 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747191820 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
Not in Commercial Distribution

  • 07332747175967 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
Not in Commercial Distribution

  • 07332747175950 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC NP
Nobel Biocare AB
38189
Not in Commercial Distribution

  • 07332747175943 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
Not in Commercial Distribution

  • 07332747175936 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
SFTWR MMT-6104 MM MBL CLIN IOS 2.0.2
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000521301 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6104 MM MBL CLIN IOS 1.0.0
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000480677 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6114 CL CONN CLIN IOS 2.1.1
MEDTRONIC MINIMED, INC.
MMT-6114
In Commercial Distribution

  • 00763000480653 ()


  • Patient health record information system application software
No Description
PIVOTAL HEALTH SOLUTIONS, INC.
EPD Package 2
In Commercial Distribution

  • 00850008449550 ()


  • Head/neck procedure positioner
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006388 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Web App
Not in Commercial Distribution

  • 00851203006173 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient Android App
Not in Commercial Distribution

  • 00851203006111 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Consumer Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer Android App
Not in Commercial Distribution

  • 00851203006036 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
Bernafon App 1.0.0 Android
Sbo Hearing A/S
242481
In Commercial Distribution

  • 05714464058921 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.4.0 ANDROID
Sbo Hearing A/S
270494
In Commercial Distribution

  • 05714464139484 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.3.0 ANDROID
Sbo Hearing A/S
269351
In Commercial Distribution

  • 05714464133918 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.2.0 ANDROID
Sbo Hearing A/S
265713
In Commercial Distribution

  • 05714464127221 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.1.0 ANDROID
Sbo Hearing A/S
264781
In Commercial Distribution

  • 05714464125159 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.5.0 ANDROID
Sbo Hearing A/S
274910
In Commercial Distribution

  • 05714464146017 ()


  • Hearing aid/implant system remote control
Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
PUMP,REPLACEMENT,APP,AIRONE
MEDLINE INDUSTRIES, INC.
MSCAOPUMP
In Commercial Distribution

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator
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