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,BT SMART REMOTE,1.0.6,ANDR
Gn Hearing A/S
20410000
In Commercial Distribution

  • 05708296071500 ()


  • Hearing aid/implant system remote control
APP,BT SMART REMOTE,1.0.6,IOS
Gn Hearing A/S
20409600
In Commercial Distribution

  • 05708296071494 ()


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

  • 00643169940765 ()


  • Neurological stereotactic surgery system
APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable
9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve
IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571
In Commercial Distribution

  • 00653160357561 ()
  • 10653160357568 ()
DYNDV2571

  • Peripheral intravenous catheterization support kit
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2591
In Commercial Distribution

  • 00653160360462 ()
  • 10653160360469 ()
DYNDV2591

  • Peripheral intravenous catheterization support kit
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571A
In Commercial Distribution

  • 00653160373646 ()
  • 10653160373643 ()
DYNDV2571A

  • Peripheral intravenous catheterization support kit
DS Panacea APP Adj Pump & Dlx
COMPASS HEALTH BRANDS CORP.
DS-APP1-ADJP
In Commercial Distribution

  • 30092237617671 ()
  • 00092237617670 ()


  • Alternating-pressure bed mattress overlay system
DS Panacea Dlx APP Pump & Pad
COMPASS HEALTH BRANDS CORP.
DS-APP2-ADJP
In Commercial Distribution

  • 30092237617701 ()
  • 00092237617700 ()


  • Alternating-pressure bed mattress overlay 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
SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system
IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software
SW APP A52200 GU PATIENT PERFICIO
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000159092 ()


  • Multiple active implantable device programmer
SW APP A51200 GU CLINICIAN PERFICIO
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000159085 ()


  • Multiple active implantable device programmer
SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software
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