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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MINI ACCESS 4FR NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST03
In Commercial Distribution

  • 40888277538857 ()
  • 10888277538856 ()
DYNJMAST03

  • General surgical procedure kit, non-medicated, reusable
2mm Guide Pin, TG (Single)
ARTHROSURFACE INCORPORATED
7007-1300
In Commercial Distribution

  • M528700713000 ()
7007-1300

  • Orthopaedic bone wire
XiVE® TG AuroBase D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254520
In Commercial Distribution

25-4520

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment Screw
Dentsply Implants Manufacturing GmbH
32254300
In Commercial Distribution

25-4300

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Castable Coping
Dentsply Implants Manufacturing GmbH
32254242
In Commercial Distribution

25-4242

  • Dental implant suprastructure kit
XiVE® TG Coping Screw
Dentsply Implants Manufacturing GmbH
32254200
In Commercial Distribution

25-4200

  • Dental implant suprastructure, permanent, preformed
VA 20mm FLL TG- VF
WEST PHARMA. SERVICES IL, . LTD
8072035
In Commercial Distribution

  • 27290108240652 ()
  • 17290108240655 ()
  • 07290108240658 ()


  • Vial/bottle adaptor, non-hermetic
APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control
SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
DreamMapper iOS China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059078 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059061 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059054 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059047 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059801 ()
1136968

  • Self-care monitoring/reporting software
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