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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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,ANDR
Gn Hearing A/S
20410100
In Commercial Distribution

  • 05708296071463 ()


  • 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
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
SFW 9735913 STEALTH S8 STEALTHVIZ APP
MEDTRONIC NAVIGATION, INC.
9735913
In Commercial Distribution

  • 00643169940765 ()


  • Neurological stereotactic surgery system
CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring
CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring
CB RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400T
Not in Commercial Distribution

  • 05690977319035 ()
515400T

  • Cervical spine immobilization head ring
J TONG SML/MED- No App
OSSUR AMERICAS, INC.
JT-215
Not in Commercial Distribution

  • 05690977308718 ()
JT-215

  • Traction system skull tongs
OB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400D
Not in Commercial Distribution

  • 05690977308657 ()
515400D

  • Cervical spine immobilization head ring
CB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500C
Not in Commercial Distribution

  • 05690977308633 ()
515500C

  • Cervical spine immobilization head ring
CB RESOLVE RING KIT SM-No App
OSSUR AMERICAS, INC.
515300C
Not in Commercial Distribution

  • 05690977308596 ()
515300C

  • Cervical spine immobilization head ring
SW APP A902 PATIENT DATA SERVICES
MEDTRONIC, INC.
A902
In Commercial Distribution

  • 00643169738065 ()


  • Multiple active implantable device programmer
SW APP A820 TDD PATIENT PROG
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00643169771048 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00643169771031 ()


  • Infusion pump programmer
SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW APP A511 GU CLINICIAN EVALUATION
MEDTRONIC, INC.
A511
In Commercial Distribution

  • 00643169834323 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software
SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer
OB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500D
Not in Commercial Distribution

  • 05690977308664 ()
515500D

  • Cervical spine immobilization head ring
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