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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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MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL4
In Commercial Distribution

  • 50195594797131 ()
  • 10195594797133 ()
SBA11LLSL4

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL5
In Commercial Distribution

  • 50195594880147 ()
  • 10195594880149 ()
SBA11LLSL5

  • Laparoscopic surgical procedure kit, non-medicated, single-use
SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00763000520076 ()


  • Multiple active implantable device programmer
SW APP A620 DBS PATIENT
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000041618 ()


  • Multiple active implantable device programmer
SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000275655 ()


  • Multiple active implantable device programmer
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLB
In Commercial Distribution

  • 50195594959188 ()
  • 10195594959180 ()
SBA11LLSLB

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLC
In Commercial Distribution

  • 50195594541888 ()
  • 10195594541880 ()
SBA11LLSLC

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL6
In Commercial Distribution

  • 50197106036479 ()
  • 10197106036471 ()
SBA11LLSL6

  • Laparoscopic surgical procedure kit, non-medicated, single-use
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system
G7 Wear OS Watch App
Dexcom, Inc.
SW14502
In Commercial Distribution

  • 00386270005175 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
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