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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OTICON COMPANION 1.3.0 IOS
Sbo Hearing A/S
269348
In Commercial Distribution

  • 05714464133888 ()


  • Hearing aid/implant system remote control
Oticon RemoteCare 3.3.0 iOS
Sbo Hearing A/S
228209
In Commercial Distribution

  • 05714464012930 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.5.0 IOS
Sbo Hearing A/S
228198
In Commercial Distribution

  • 05714464012824 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.5.0 IOS
Sbo Hearing A/S
228196
In Commercial Distribution

  • 05714464012800 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.1.0 IOS
Sbo Hearing A/S
219643
In Commercial Distribution

  • 05714464006458 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.3.0 iOS
Sbo Hearing A/S
228203
In Commercial Distribution

  • 05714464012879 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 IOS
Sbo Hearing A/S
228193
In Commercial Distribution

  • 05714464012770 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 IOS
Sbo Hearing A/S
226657
In Commercial Distribution

  • 05714464012275 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.4.0 IOS
Sbo Hearing A/S
226431
In Commercial Distribution

  • 05714464012084 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.4.0 IOS
Sbo Hearing A/S
226429
In Commercial Distribution

  • 05714464012060 ()


  • Hearing aid/implant system remote control
OTICON ON 2.3.0 IOS
Sbo Hearing A/S
224170
In Commercial Distribution

  • 05714464011612 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.3.0 IOS
Sbo Hearing A/S
220593
In Commercial Distribution

  • 05714464011308 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.3.0 IOS
Sbo Hearing A/S
220591
In Commercial Distribution

  • 05714464011285 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215188
In Commercial Distribution

  • 05714464004645 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.1.0 IOS
Sbo Hearing A/S
214715
In Commercial Distribution

  • 05714464003617 ()


  • Hearing aid/implant system remote control
Oticon RemoteCare 3.4.0 iOS
Sbo Hearing A/S
236788
In Commercial Distribution

  • 05714464042463 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.4.0 iOS
Sbo Hearing A/S
234034
In Commercial Distribution

  • 05714464034673 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.5.0 IOS
Sbo Hearing A/S
247221
In Commercial Distribution

  • 05714464060313 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246114
In Commercial Distribution

  • 05714464059805 ()


  • Hearing aid/implant system remote control
Oticon Companion 1.0.0 iOS
Sbo Hearing A/S
243486
In Commercial Distribution

  • 05714464059331 ()


  • Hearing aid/implant system remote control
SoundLink 3 1.0.0 iOS
Sbo Hearing A/S
242486
In Commercial Distribution

  • 05714464058976 ()


  • Hearing aid/implant system remote control
RemoteLink 2 1.0.0 iOS
Sbo Hearing A/S
242484
In Commercial Distribution

  • 05714464058952 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 IOS
Sonic Innovations, Inc.
214710
In Commercial Distribution

  • 05711583038216 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.0 IOS
Sonic Innovations, Inc.
204547
In Commercial Distribution

  • 05711583037455 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 IOS
Sonic Innovations, Inc.
199525
In Commercial Distribution

  • 05711583037417 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.9 IOS
Sonic Innovations, Inc.
189262
In Commercial Distribution

  • 05711583031880 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.4 IOS
Sonic Innovations, Inc.
178497
In Commercial Distribution

  • 05711584074695 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.8 IOS
Sonic Innovations, Inc.
185787
In Commercial Distribution

  • 05711583030142 ()


  • Hearing aid/implant system remote control
iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
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
FreeStyle LibreLink iOS US
ABBOTT DIABETES CARE INC
71733-01
In Commercial Distribution

  • 00357599000059 ()
71733-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software
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
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 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
Not in Commercial Distribution

  • 07332747176278 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • 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 RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747113761 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • 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
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
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