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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J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software
BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control
APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
DreamMapper Mobile App Android (APAC)
Respironics, Inc.
DreamMapper Mobile App Android, Asia- Pacific Instance - 2
In Commercial Distribution

  • 00606959057678 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
DreamMapper Mobile App Android EMEA, - 2
In Commercial Distribution

  • 00606959057661 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (DMM)
Respironics, Inc.
DreamMapper Mobile App Android, North America Instance - 2
In Commercial Distribution

  • 00606959057654 ()
1101479

  • Self-care monitoring/reporting software
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
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
Not in Commercial Distribution

  • 03770014642226 ()


  • Pelvic floor muscle exerciser
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink
Not in Commercial Distribution

  • 03770014642004 ()


  • Pelvic floor muscle exerciser
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649286 ()


  • Cardiopulmonary physiological parameter analysis software
Genesis Deluxe APP Pump/Pad
COMPASS HEALTH BRANDS CORP.
APP-2000-GBN
In Commercial Distribution

  • 40092237602230 ()
  • 00092237602232 ()


  • Alternating-pressure bed mattress overlay system
Genesis standard APP pump/pad
COMPASS HEALTH BRANDS CORP.
APP-1000-GBN
In Commercial Distribution

  • 40092237602223 ()
  • 00092237602225 ()


  • Alternating-pressure bed mattress overlay system
DS Replacement APP Pad (Double
COMPASS HEALTH BRANDS CORP.
DS-APP2
In Commercial Distribution

  • 30092237617695 ()
  • 00092237617694 ()


  • Alternating-pressure bed mattress overlay, reusable
DS Panacea APP & Pad Syst.,
COMPASS HEALTH BRANDS CORP.
DS-APP1-NADJP
In Commercial Distribution

  • 30092237617688 ()
  • 00092237617687 ()


  • Alternating-pressure bed mattress overlay system
MY MASSAGE APP CONTROLLED CUSH
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
MCS-1000HJ
In Commercial Distribution

  • 10031262071719 ()
  • 00031262071712 ()


  • Bed/chair electric massager
TRUE MANAGER AIR APP - Android
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Android
In Commercial Distribution

  • 00021292013622 ()


  • Self-care monitoring/reporting software
BARANY Noise App. w. olive
Karl Storz GmbH & Co. KG
130000
In Commercial Distribution

  • 04048551054543 ()


  • Audiometric-evaluation noise system
Lathbury cotton app 6" regular
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.80
In Commercial Distribution

  • 04046826203399 ()
955.62.80

  • Surgical tamp, reusable
Lathbury cotton app 6" triang
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.20
In Commercial Distribution

  • 04046826203375 ()
955.62.20

  • Surgical tamp, reusable
Lathbury cotton app 6" triang
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.00
In Commercial Distribution

  • 04046826203368 ()
955.62.00

  • Surgical tamp, reusable
Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL7
In Commercial Distribution

  • 50198956001310 ()
  • 10198956001312 ()
SBA11LLSL7

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL8
In Commercial Distribution

  • 50198956020595 ()
  • 10198956020597 ()
SBA11LLSL8

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Unitron Remote Plus 4.0 app
Unitron Hearing Division
088-5013
In Commercial Distribution

  • 07613389465013 ()
088-5013

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015
In Commercial Distribution

  • 07613389432220 ()
088-0015

  • Audiometric/hearing device software
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