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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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
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • 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
REMOTELINK 1.2 ANDROID
Oticon A/S
176637
In Commercial Distribution

  • 05707131328540 ()


  • 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
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
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
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
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
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 2.1.0 ANDROID
Lehiso A/S
214714
Not in Commercial Distribution

  • 05713708000221 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.0 ANDROID
Lehiso A/S
204457
Not in Commercial Distribution

  • 05713708000184 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.10 ANDROID
Lehiso A/S
199526
Not in Commercial Distribution

  • 05713708000146 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.9 ANDROID
Lehiso A/S
189261
Not in Commercial Distribution

  • 05713708000122 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.8 ANDROID
Lehiso A/S
185789
Not in Commercial Distribution

  • 05713708000078 ()


  • 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
RemoteFit 3.4.0 Android
Sbo Hearing A/S
236789
In Commercial Distribution

  • 05714464042470 ()


  • 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
iCare PATIENT2 (Android version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851104 ()


  • Medical equipment clinical data interfacing software
OTICON ON 2.1.0 ANDROID
Oticon A/S
219644
In Commercial Distribution

  • 05707131395467 ()


  • Hearing aid/implant system remote control
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