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 Class Implantable

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RemoteFit 3.3.0 Android
Sbo Hearing A/S
228206
In Commercial Distribution

  • 05714464012909 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.5.0 ANDROID
Sbo Hearing A/S
228200
In Commercial Distribution

  • 05714464012848 ()


  • Hearing aid/implant system remote control
HEARLINK 2.0 ANDROID
Sbo Hearing A/S
204545
In Commercial Distribution

  • 05714464002825 ()


  • Hearing aid/implant system remote control
HEARLINK 1.0 ANDROID
Sbo Hearing A/S
199531
In Commercial Distribution

  • 05714464000074 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.5.0 ANDROID
Sbo Hearing A/S
228194
In Commercial Distribution

  • 05714464012787 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.4.0 ANDROID
Sbo Hearing A/S
226432
In Commercial Distribution

  • 05714464012091 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.4.0 ANDROID
Sbo Hearing A/S
226427
In Commercial Distribution

  • 05714464012046 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.3.0 ANDROID
Sbo Hearing A/S
220588
In Commercial Distribution

  • 05714464011254 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.3.0 ANDROID
Sbo Hearing A/S
220594
In Commercial Distribution

  • 05714464011209 ()


  • Hearing aid/implant system remote control
REMOTEFIT 3.1.0 ANDROID
Sbo Hearing A/S
220352
In Commercial Distribution

  • 05714464006625 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.1.0 ANDROID
Bernafon AG
214718
In Commercial Distribution

  • 05711584115886 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.0 ANDROID
Bernafon AG
204544
In Commercial Distribution

  • 05711584106587 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.10 ANDROID
Bernafon AG
199522
In Commercial Distribution

  • 05711584095508 ()


  • Hearing aid/implant system remote control
RemoteFit 3.4.0 Android
Sbo Hearing A/S
236789
In Commercial Distribution

  • 05714464042470 ()


  • Hearing aid/implant system remote control
REMOTEFIT 3.5.0 ANDROID
Sbo Hearing A/S
247220
In Commercial Distribution

  • 05714464060306 ()


  • Hearing aid/implant system remote control
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
EASYCONTROL-A 1.9 ANDROID
Oticon A/S
189255
In Commercial Distribution

  • 05711584085349 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.8 ANDROID
Bernafon AG
185792
In Commercial Distribution

  • 05711584083208 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.4 ANDROID
Bernafon AG
178501
In Commercial Distribution

  • 05711583029917 ()


  • Hearing aid/implant system remote control
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Mobile application (Android)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43171
In Commercial Distribution

  • 09008737431716 ()


  • Audiometric/hearing device software
Mobile application (Android)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41342
In Commercial Distribution

  • 09008737413422 ()


  • Audiometric/hearing device software
A104BT White Android
HEARING LAB TECHNOLOGY, LLC
606*
In Commercial Distribution

  • 00810068832617 ()
LH-A104BT-PW

  • Air-conduction hearing aid, receiver-in-canal
A104BT Brown Android
HEARING LAB TECHNOLOGY, LLC
606*
In Commercial Distribution

  • 00810068832594 ()
LH-A104BT-BR

  • Air-conduction hearing aid, receiver-in-canal
A104BT Grey Android
HEARING LAB TECHNOLOGY, LLC
606*
In Commercial Distribution

  • 00810068832570 ()
LH-A104BT-GR

  • Air-conduction hearing aid, receiver-in-canal
A104BT Black Android
HEARING LAB TECHNOLOGY, LLC
606*
In Commercial Distribution

  • 00810068832556 ()
LH-A104BT-BK

  • Air-conduction hearing aid, receiver-in-canal
A104BT Beige Android
HEARING LAB TECHNOLOGY, LLC
606*
In Commercial Distribution

  • 00810068832532 ()
LH-A104BT-BG

  • Air-conduction hearing aid, receiver-in-canal
Knot pusher for placing knots for laparoscopic surgery. The various Knotpushers are intended for ligature passing and knot tying.
AMI Agency for Medical Innovations GmbH
APK 001
Not in Commercial Distribution

  • EAMIAPK0010 ()
APK 001

  • Suture knot pusher, reusable
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - Android
Novidan, Inc.
99-0011-01
In Commercial Distribution

  • 00850049194471 ()


  • Air-conduction hearing aid, receiver-in-canal
OTICON ON 2.1.0 ANDROID
Oticon A/S
219644
In Commercial Distribution

  • 05707131395467 ()


  • Hearing aid/implant system remote control
TALA Android EARPIECE RIGHT
ETYMOTIC RESEARCH, INC.
TALA ANDROID EARP R
In Commercial Distribution

  • 00846430005853 ()


  • Air-conduction hearing aid, in-the-ear
TALA Android EARPIECE LEFT
ETYMOTIC RESEARCH, INC.
TALA ANDROID EARP L
In Commercial Distribution

  • 00846430005846 ()


  • Air-conduction hearing aid, in-the-ear
OTICON ON 2.0 ANDROID
Oticon A/S
204455
In Commercial Distribution

  • 05707131357618 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.0 ANDROID
Oticon A/S
204453
In Commercial Distribution

  • 05707131357595 ()


  • Hearing aid/implant system remote control
OTICON ON 1.10 ANDROID
Oticon A/S
199519
In Commercial Distribution

  • 05707131349217 ()


  • Hearing aid/implant system remote control
OTICON ON 1.9 ANDROID
Bernafon AG
189259
In Commercial Distribution

  • 05707131337368 ()


  • Hearing aid/implant system remote control
OTICON ON 1.8 ANDROID
Oticon A/S
185788
In Commercial Distribution

  • 05707131335081 ()


  • Hearing aid/implant system remote control
OTICON ON 1.4 ANDROID
Oticon A/S
178498
In Commercial Distribution

  • 05707131329998 ()


  • Hearing aid/implant system remote control
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
t:connect Mobile Application (Android)
Tandem Diabetes Care, Inc.
1004127
In Commercial Distribution

  • 00850006613267 ()


  • Ambulatory insulin infusion pump software, data-display
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • 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
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