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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ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL1
In Commercial Distribution

  • 50888439686430 ()
  • 10888439686432 ()
SBA11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use
SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution

  • 10080196403905 ()
MSCAIRONE220

  • Alternating-pressure bed mattress overlay, reusable
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system
BARANY Noise App. w. olive
Karl Storz GmbH & Co. KG
130000
In Commercial Distribution

  • 04048551054543 ()


  • Audiometric-evaluation noise system
DreamMapper Mobile App Android (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048553 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048546 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (DMM)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048539 ()
1101479

  • Self-care monitoring/reporting software
APP,JABRA,ENHANCE,1.0.0,IOS
Gn Hearing A/S
22153200
In Commercial Distribution

  • 05708296229185 ()


  • Hearing aid/implant system remote control
Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
FW updater App 1.0.0 iOS
Sbo Hearing A/S
232872
In Commercial Distribution

  • 05714464033829 ()


  • Hearing aid wireless-fitting computer-aided set
APP,AUDIGY ATTUNE,1.2,ANDR
Gn Hearing A/S
20789100
In Commercial Distribution

  • 05708296097258 ()


  • Hearing aid/implant system remote control
APP,AUDIGY ATTUNE,1.2,IOS
Gn Hearing A/S
20789000
In Commercial Distribution

  • 05708296097241 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,ANDR
Gn Hearing A/S
20681500
In Commercial Distribution

  • 05708296095575 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,IOS
Gn Hearing A/S
20681400
In Commercial Distribution

  • 05708296095568 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,ANDR
Gn Hearing A/S
20664000
In Commercial Distribution

  • 05708296095308 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,IOS
Gn Hearing A/S
20663900
In Commercial Distribution

  • 05708296095292 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,ANDR
Gn Hearing A/S
20425500
In Commercial Distribution

  • 05708296076703 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
In Commercial Distribution

  • 05708296074235 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,ANDR
Gn Hearing A/S
20416600
In Commercial Distribution

  • 05708296074211 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
In Commercial Distribution

  • 05708296074259 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution

  • 05708296071548 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,ANDR
Gn Hearing A/S
20409900
In Commercial Distribution

  • 05708296071449 ()


  • Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,IOS
Gn Hearing A/S
20409500
In Commercial Distribution

  • 05708296071432 ()


  • Hearing aid/implant system remote control
APP,MY LIVELY 1.4,ANDR
Gn Hearing A/S
21123100
In Commercial Distribution

  • 05708296169719 ()


  • Hearing aid/implant system remote control
APP,MY LIVELY 1.4,IOS
Gn Hearing A/S
21123000
In Commercial Distribution

  • 05708296169702 ()


  • Hearing aid/implant system remote control
APP,KS DISCOVER,1.4,ANDR
Gn Hearing A/S
20665300
In Commercial Distribution

  • 05708296164301 ()


  • Hearing aid/implant system remote control
APP,KS DISCOVER,1.4,IOS
Gn Hearing A/S
20665200
In Commercial Distribution

  • 05708296164295 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,ANDR
Gn Hearing A/S
20993700
In Commercial Distribution

  • 05708296158478 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,IOS
Gn Hearing A/S
20993600
In Commercial Distribution

  • 05708296158461 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,4.0,ANDR
Gn Hearing A/S
20993500
In Commercial Distribution

  • 05708296158454 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,4.0,IOS
Gn Hearing A/S
20993400
In Commercial Distribution

  • 05708296158447 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,ANDR
Gn Hearing A/S
20993300
In Commercial Distribution

  • 05708296158430 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,IOS
Gn Hearing A/S
20993200
In Commercial Distribution

  • 05708296158423 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,ANDR
Gn Hearing A/S
20993100
In Commercial Distribution

  • 05708296158416 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,IOS
Gn Hearing A/S
20993000
In Commercial Distribution

  • 05708296158409 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,ANDR
Gn Hearing A/S
21820100
In Commercial Distribution

  • 05708296214655 ()


  • Hearing aid/implant system remote control
Sony | Hearing Control App WA
Ws Audiology Usa, Inc.
Sony | Hearing Control WA
In Commercial Distribution

  • 05714880199420 ()
21026345

  • Audiometric/hearing device software
BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution

  • 00851203006272 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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