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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Philips HearLink Connect 3.4.0 iOS
Sbo Hearing A/S
234032
In Commercial Distribution

  • 05714464034659 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.4.0 iOS
Sbo Hearing A/S
234030
In Commercial Distribution

  • 05714464034635 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.4.0 iOS
Sbo Hearing A/S
234028
In Commercial Distribution

  • 05714464034611 ()


  • Hearing aid/implant system remote control
FW updater App 1.0.0 iOS
Sbo Hearing A/S
232872
In Commercial Distribution

  • 05714464033829 ()


  • Hearing aid wireless-fitting computer-aided set
PHILIPS HEARLINK 2 1.4.0 IOS
Sbo Hearing A/S
270492
In Commercial Distribution

  • 05714464139460 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.3.0 IOS
Sbo Hearing A/S
269358
In Commercial Distribution

  • 05714464133987 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK 3 1.2.0 IOS
Sbo Hearing A/S
265708
In Commercial Distribution

  • 05714464127177 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.2.0 IOS
Sbo Hearing A/S
265706
In Commercial Distribution

  • 05714464127153 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 IOS
Sbo Hearing A/S
264788
In Commercial Distribution

  • 05714464125227 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.5.0 IOS
Sbo Hearing A/S
274917
In Commercial Distribution

  • 05714464146086 ()


  • Hearing aid/implant system remote control
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Wide Neck TG Fixture Mount
TITAN IMPLANT INC
ITI-WNTGM
In Commercial Distribution

  • 00842448103475 ()


  • Dental implant system
Standard Diameter TG Fixture Mount
TITAN IMPLANT INC
ITI-STGM
In Commercial Distribution

  • 00842448103444 ()


  • Dental implant system
MINI ACCESS 4FR SS/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST05
In Commercial Distribution

  • 40888277538871 ()
  • 10888277538870 ()
DYNJMAST05

  • General surgical procedure kit, non-medicated, reusable
MINI ACCESS 5FR NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST04
In Commercial Distribution

  • 40888277538864 ()
  • 10888277538863 ()
DYNJMAST04

  • General surgical procedure kit, non-medicated, reusable
MINI ACCESS 4FR NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST03
In Commercial Distribution

  • 40888277538857 ()
  • 10888277538856 ()
DYNJMAST03

  • General surgical procedure kit, non-medicated, reusable
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
IOS VMAX SERIES OPTION-ICU CART
VYAIRE MEDICAL, INC.
776268-103
In Commercial Distribution

  • 10190752164154 ()
776268-103

  • Neonatal/adult intensive-care ventilator
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047532 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042018 ()
1128264

  • Self-care monitoring/reporting software
4.8mm TG Hex Abutment Screw
TITAN IMPLANT INC
T-48TGHAS
In Commercial Distribution

  • 00842448109842 ()


  • Dental prosthesis/implant abutment screw
4.8mm TG Hex Abutment Analog
TITAN IMPLANT INC
T-48TGHAA
In Commercial Distribution

  • 00842448109835 ()


  • Dental implant abutment analog, laboratory
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046818 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044401 ()
1128264

  • Self-care monitoring/reporting software
XiVE® TG AuroBase D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254520
Not in Commercial Distribution

  • EFRI322545202 ()
25-4520

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment Screw
Dentsply Implants Manufacturing GmbH
32254300
Not in Commercial Distribution

  • EFRI322543002 ()
25-4300

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Castable Coping
Dentsply Implants Manufacturing GmbH
32254242
Not in Commercial Distribution

  • EFRI322542422 ()
25-4242

  • Dental implant suprastructure kit
XiVE® TG Coping Screw
Dentsply Implants Manufacturing GmbH
32254200
Not in Commercial Distribution

  • EFRI322542002 ()
25-4200

  • Dental implant suprastructure, permanent, preformed
3.8mm Platform TG Implant Analog
TITAN IMPLANT INC
P-38TGIA-AL
In Commercial Distribution

  • 00842448116819 ()


  • Dental implant analog
6.5mm TG Hex Abutment Analog
TITAN IMPLANT INC
TN2-65TGHAA-AL
In Commercial Distribution

  • 00842448115560 ()


  • Dental implant abutment analog, laboratory
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