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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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
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery 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
Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer
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
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
APP PUMP NO PRESSURE REGULATOR
COMPASS HEALTH BRANDS CORP.
1001
In Commercial Distribution

  • 30815067040033 ()
  • 00815067040032 ()


  • Alternating-pressure inflator
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
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
Easy Line Remote 2.0 app
Sonova AG
088-0012
In Commercial Distribution

  • 07613389402575 ()
088-0012

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-19
In Commercial Distribution

  • 07613389402568 ()
088-0012-19

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-06
In Commercial Distribution

  • 07613389402551 ()
088-0012-06

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-17
In Commercial Distribution

  • 07613389402537 ()
088-0012-17

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-70
In Commercial Distribution

  • 07613389402513 ()
088-0012-70

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-04
In Commercial Distribution

  • 07613389402544 ()
088-0012-04

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-18
In Commercial Distribution

  • 07613389402520 ()
088-0012-18

  • Audiometric/hearing device software
Easy Line Remote 2.0 app
Sonova AG
088-0012-02
In Commercial Distribution

  • 07613389398700 ()
088-0012-02

  • Audiometric/hearing device software
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
Classic TouchChat w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021039 ()
18626-1

  • Voice synthesizer/digitizer
TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer
Unitron Remote Plus 5.0 app
Sonova AG
088-5016
In Commercial Distribution

  • 07613389610918 ()
088-5016

  • Audiometric/hearing device software
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
Easy Line Remote 3.0 app
Sonova AG
088-0015-06
In Commercial Distribution

  • 07613389432213 ()
088-0015-06

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015-19
In Commercial Distribution

  • 07613389431704 ()
088-0015-19

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015-17
In Commercial Distribution

  • 07613389431698 ()
088-0015-17

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015-04
In Commercial Distribution

  • 07613389431681 ()
088-0015-04

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015-02
In Commercial Distribution

  • 07613389431674 ()
088-0015-02

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015-18
In Commercial Distribution

  • 07613389431667 ()
088-0015-18

  • Audiometric/hearing device software
Easy Line Remote 3.0 app
Sonova AG
088-0015-70
In Commercial Distribution

  • 07613389431650 ()
088-0015-70

  • Audiometric/hearing device software
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLD
In Commercial Distribution

  • 50197106436514 ()
  • 10197106436516 ()
SBA11LLSLD

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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
SBA11LLSLF
In Commercial Distribution

  • 50197106899883 ()
  • 10197106899885 ()
SBA11LLSLF

  • 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
SBA11LLSLC
In Commercial Distribution

  • 50195594541888 ()
  • 10195594541880 ()
SBA11LLSLC

  • 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 A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00763000520076 ()


  • 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
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL6
In Commercial Distribution

  • 50197106036479 ()
  • 10197106036471 ()
SBA11LLSL6

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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