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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No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device software
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
Not in Commercial Distribution

  • 07109615470598 ()


  • Pelvic floor muscle exerciser
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
SBA11LLSLF
In Commercial Distribution

  • 50197106899883 ()
  • 10197106899885 ()
SBA11LLSLF

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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
088-0015-18
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
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
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
088-0015-04
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 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
088-0012-17
In Commercial Distribution

  • 07613389402537 ()
088-0012-17

  • 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
088-0012-70
In Commercial Distribution

  • 07613389402513 ()
088-0012-70

  • 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
SBA11LLSL8
In Commercial Distribution

  • 50198956020595 ()
  • 10198956020597 ()
SBA11LLSL8

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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
SBA11LLSLE
In Commercial Distribution

  • 50197106767748 ()
  • 10197106767740 ()
SBA11LLSLE

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

  • 30815067040033 ()
  • 00815067040032 ()


  • Alternating-pressure inflator
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
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
G7 Wear OS Watch App
Dexcom, Inc.
SW14502
In Commercial Distribution

  • 00386270005175 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
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
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
SW APP A901 COMM MANAGER
MEDTRONIC, INC.
A901
In Commercial Distribution

  • 00643169738058 ()


  • Multiple active implantable device programmer
SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00643169738041 ()


  • Multiple active implantable device programmer
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL2
In Commercial Distribution

  • 50888439768440 ()
  • 10888439768442 ()
SBA11LLSL2

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLA
In Commercial Distribution

  • 50888439463963 ()
  • 10888439463965 ()
SBA11LLSLA

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Protekt Adjustable APP Pump Only
PROACTIVE MEDICAL PRODUCTS, LLC
80010-PUMP
In Commercial Distribution

  • 05060488570377 ()

  • Width: 13 Inch
  • Length: 7.5 Inch
  • Height: 9 Inch
80010-PUMP

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

  • 00643169491748 ()


  • ENT stereotactic surgery system
J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
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