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 Class Implantable

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IOS external fixator system (short)
METAPHYSIS LLP
2-0-0S
In Commercial Distribution

  • 05060309872017 ()


  • External orthopaedic fixation system, single-use
IOS external fixator system (Long)
METAPHYSIS LLP
2-0-0L
In Commercial Distribution

  • 05060309872000 ()


  • External orthopaedic fixation system, single-use
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
IBP interface cable/华南医电/Edwards/LP5/4.0M
Unimed Medical Supplies, Inc.
BC-HY-ED
In Commercial Distribution

  • 06945664869171 ()


  • Electrical-only medical device connection cable, reusable
MasterScreen IOS
Jaeger Medical GmbH
V-176420
In Commercial Distribution

  • 04250892905631 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
In Commercial Distribution

  • 04250892905259 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
In Commercial Distribution

  • 04250892905242 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
In Commercial Distribution

  • 04250892905235 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892900452 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892900438 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-376406
In Commercial Distribution

  • 04250892905808 ()
V-376406

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892902777 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892902760 ()
V-176420-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892902746 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
Not in Commercial Distribution

  • 04250892900513 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
Not in Commercial Distribution

  • 04250892900476 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420
Not in Commercial Distribution

  • 04250892900469 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892900445 ()
V-176420-03

  • Pulmonary function analysis system, adult
G6 iOS
Dexcom, Inc.
SW11677
In Commercial Distribution

  • 00386270000804 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
6.0
In Commercial Distribution

  • 09321502065764 ()
P1861019

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software
myAir (iOS)
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840039 ()


  • Self-care monitoring/reporting software
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

  • Self-care monitoring/reporting software
G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper Application iOS
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044340 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041943 ()
1101478

  • Self-care monitoring/reporting software
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43307
In Commercial Distribution

  • 09008737433079 ()


  • Audiometric/hearing device software
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41341
In Commercial Distribution

  • 09008737413415 ()


  • Audiometric/hearing device software
DreamMapper App iOS
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048560 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047525 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046740 ()
1101478

  • Self-care monitoring/reporting software
EASYCONTROL-A 2.0 IOS
Bernafon AG
204543
In Commercial Distribution

  • 05711584106570 ()


  • Hearing aid/implant system remote control
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