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 iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
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
SBA11LLSL5
In Commercial Distribution

  • 50195594880147 ()
  • 10195594880149 ()
SBA11LLSL5

  • 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
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLE
In Commercial Distribution

  • 50197106767748 ()
  • 10197106767740 ()
SBA11LLSLE

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
Not in Commercial Distribution

  • 07109615470598 ()


  • Pelvic floor muscle exerciser
SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000275655 ()


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

  • 00763000041618 ()


  • Multiple active implantable device programmer
MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use
SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00763000520076 ()


  • Multiple active implantable device programmer
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLD
In Commercial Distribution

  • 50197106436514 ()
  • 10197106436516 ()
SBA11LLSLD

  • 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
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
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
KIT TISSEEL APP 16GA X 3.75
MEDLINE INDUSTRIES, INC.
DYNDA2944
In Commercial Distribution

  • 40195327155569 ()
  • 10195327155568 ()
DYNDA2944

  • General surgical procedure kit, non-medicated, single-use
SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software
APP,RS SMART 3D,1.0,ANDR
Gn Hearing A/S
20410700
In Commercial Distribution

  • 05708296071524 ()


  • Hearing aid/implant system remote control
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
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 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
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
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 STD-No App
OSSUR AMERICAS, INC.
515400C
Not in Commercial Distribution

  • 05690977308626 ()
515400C

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

  • 05690977308664 ()
515500D

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

  • 05690977308640 ()
515300D

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

  • 00643169738065 ()


  • Multiple active implantable device programmer
Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
DS Panacea Dlx APP Pump & Pad
COMPASS HEALTH BRANDS CORP.
DS-APP2-ADJP
In Commercial Distribution

  • 30092237617701 ()
  • 00092237617700 ()


  • Alternating-pressure bed mattress overlay system
DS Panacea APP Adj Pump & Dlx
COMPASS HEALTH BRANDS CORP.
DS-APP1-ADJP
In Commercial Distribution

  • 30092237617671 ()
  • 00092237617670 ()


  • Alternating-pressure bed mattress overlay system
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