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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IOS Healing Abutment Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
300992
In Commercial Distribution

  • 07332747162967 ()
300992

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
300991
In Commercial Distribution

  • 07332747162950 ()
300991

  • Dental implant suprastructure, temporary, preformed, single-use
SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system
SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system
SFTWR 9730897 KIT FUNCTIONAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730897
In Commercial Distribution

  • 00721902865558 ()


  • Multi-purpose stereotactic surgery system
APP,RS SMART 3D,1.0,ANDR
Gn Hearing A/S
20410700
In Commercial Distribution

  • 05708296071524 ()


  • Hearing aid/implant system remote control
APP,BT SMART REMOTE,1.0.6,ANDR
Gn Hearing A/S
20410000
In Commercial Distribution

  • 05708296071500 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,ANDR
Gn Hearing A/S
20410100
In Commercial Distribution

  • 05708296071463 ()


  • Hearing aid/implant system remote control
SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer
SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer
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