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 3.5.0 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
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
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
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
OTICON COMPANION 1.5.0 ANDROID
Sbo Hearing A/S
274918
In Commercial Distribution

  • 05714464146093 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.5.0 ANDROID
Sbo Hearing A/S
274914
In Commercial Distribution

  • 05714464146055 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274912
In Commercial Distribution

  • 05714464146031 ()


  • 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
OTICON COMPANION 1.4.0 ANDROID
Sbo Hearing A/S
270498
In Commercial Distribution

  • 05714464139521 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.4.0 ANDROID
Sbo Hearing A/S
270496
In Commercial Distribution

  • 05714464139507 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.4.0 ANDROID
Sbo Hearing A/S
270495
In Commercial Distribution

  • 05714464139491 ()


  • 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
SOUNDLINK 3 1.3.0 ANDROID
Sbo Hearing A/S
269355
In Commercial Distribution

  • 05714464133956 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.3.0 ANDROID
Sbo Hearing A/S
269353
In Commercial Distribution

  • 05714464133932 ()


  • 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
OTICON COMPANION 1.3.0 ANDROID
Sbo Hearing A/S
269347
In Commercial Distribution

  • 05714464133871 ()


  • Hearing aid/implant system remote control
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