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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for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
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
G6 iOS
Dexcom, Inc.
SW11677
In Commercial Distribution

  • 00386270000804 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
MasterScreen IOS
Jaeger Medical GmbH
V-376406
In Commercial Distribution

  • 04250892905808 ()
V-376406

  • Pulmonary function analysis system, adult
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
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
176400
Not in Commercial Distribution

  • 04250892900452 ()
176400

  • 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
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892900438 ()
V-176400-03

  • Pulmonary function analysis system, adult
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
Reusable SpO2 Sensor/超思/Finger clip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410B-96
In Commercial Distribution

  • 06945664821162 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/超思/Soft Tip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410S-96
In Commercial Distribution

  • 06945664821155 ()


  • Pulse oximeter probe, reusable
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
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
SAW ATTACHMENT/IN-LINE FOR EPD AND APD
Synthes GmbH
05.001.183
In Commercial Distribution

  • 07611819414792 ()
  • H679050011830 ()
  • 10886982129567 ()
05001183

  • Sawing power tool attachment, sagittal
IRRIGATION NOZZLE FOR EPD HEX DRILLING ATTACHMENT
Synthes GmbH
05.001.111
In Commercial Distribution

  • 07611819798205 ()
  • H679050011110 ()
  • 10886982129338 ()
05001111

  • Surgical irrigation/aspiration tubing set
ADAPTOR FOR MAINTENANCE SPRAY FOR EPD ATTACHMENTS
Synthes GmbH
05.001.102
In Commercial Distribution

  • 07611819872080 ()
  • H679050011020 ()
  • 10886982129253 ()
05001102

  • Surgical power tool maintenance adaptor
IRRIGATION NOZZLE FOR EPD FOR PERFORATOR 05.001.054
Synthes GmbH
05.001.076
In Commercial Distribution

  • H679050010760 ()
  • 10886982128973 ()
  • 07611819816657 ()
05001076

  • Surgical irrigation/aspiration tubing set
IRRIGATION NOZZLE FOR EPD RECIPROCATING SAW ATTACHMENT
Synthes GmbH
05.001.071
In Commercial Distribution

  • H679050010710 ()
  • 10886982128935 ()
  • 07611819168091 ()
05001071

  • Surgical power tool irrigation-control device
IRRIGATION NOZZLE FOR EPD SAGITTAL SAW ATTACHMENT
Synthes GmbH
05.001.070
In Commercial Distribution

  • H679050010700 ()
  • 10886982128928 ()
  • 07611819168084 ()
05001070

  • Surgical power tool irrigation-control device
STANDARD CONSOLE-W/IRRIGATION W/O TORQUE-LIMITING-F/EPD
Synthes GmbH
05.001.006
In Commercial Distribution

  • H679050010060 ()
  • 10886982128188 ()
05001006

  • Surgical power tool system control unit, line-powered
EPD Permanent Pacing Drape 75" x 125"
ARGON MEDICAL DEVICES, INC.
397100
In Commercial Distribution

  • 20886333212747 ()
  • 00886333212743 ()

  • 75" x 125"
397100

  • Angiographic drape
Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive
REMOTELINK 1.2 IOS
Oticon A/S
176636
In Commercial Distribution

  • 05707131328533 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.1.0 IOS
Lehiso A/S
214712
Not in Commercial Distribution

  • 05713708000214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.0 IOS
Lehiso A/S
204456
Not in Commercial Distribution

  • 05713708000177 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.10 IOS
Lehiso A/S
199527
Not in Commercial Distribution

  • 05713708000153 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.9 IOS
Lehiso A/S
189260
Not in Commercial Distribution

  • 05713708000115 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.8 IOS
Lehiso A/S
185784
Not in Commercial Distribution

  • 05713708000054 ()


  • Hearing aid/implant system remote control
RemoteFit 3.3.0 iOS
Sbo Hearing A/S
228207
In Commercial Distribution

  • 05714464012916 ()


  • Hearing aid/implant system remote control
HEARLINK 2.0 IOS
Sbo Hearing A/S
204546
In Commercial Distribution

  • 05714464002832 ()


  • Hearing aid/implant system remote control
HEARLINK 1.0 IOS
Sbo Hearing A/S
199530
In Commercial Distribution

  • 05714464000012 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.5.0 IOS
Sbo Hearing A/S
228201
In Commercial Distribution

  • 05714464012855 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.5.0 IOS
Sbo Hearing A/S
228195
In Commercial Distribution

  • 05714464012794 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.4.0 IOS
Sbo Hearing A/S
226433
In Commercial Distribution

  • 05714464012107 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.4.0 IOS
Sbo Hearing A/S
226426
In Commercial Distribution

  • 05714464012039 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.3.0 IOS
Sbo Hearing A/S
220589
In Commercial Distribution

  • 05714464011261 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.3.0 IOS
Sbo Hearing A/S
220595
In Commercial Distribution

  • 05714464011193 ()


  • Hearing aid/implant system remote control
REMOTEFIT 3.1.0 IOS
Sbo Hearing A/S
220351
In Commercial Distribution

  • 05714464006618 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.1.0 IOS
Bernafon AG
214717
In Commercial Distribution

  • 05711584115879 ()


  • Hearing aid/implant system remote control
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