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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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Reusable SpO2 Sensor, Pediatric Soft
APK Technology Co.,Ltd.
S103S-060
In Commercial Distribution

  • 06946725541883 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Pediatric Soft
APK Technology Co.,Ltd.
S203S-060
In Commercial Distribution

  • 06946725541845 ()


  • Pulse Co-oximeter probe, reusable
Disposable SpO2 Sensor,Pediatric non-woven fabric
APK Technology Co.,Ltd.
S523-42D0
In Commercial Distribution

  • 06946725541654 ()
  • 16946725591618 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Adult Soft
APK Technology Co.,Ltd.
S410S-080
In Commercial Distribution

  • 06946725541647 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Pediatric Soft
APK Technology Co.,Ltd.
S310-010
In Commercial Distribution

  • 06946725541623 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Pediatric Soft
APK Technology Co.,Ltd.
S103S-1170
In Commercial Distribution

  • 06946725541616 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
S103-1250
In Commercial Distribution

  • 06946725541302 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Pediatric Soft
APK Technology Co.,Ltd.
S110S-208D0
In Commercial Distribution

  • 06946725541296 ()


  • Pulse Co-oximeter probe, reusable
Comen Compatible Adult Finger Clip Reusable SpO2 Sensor
APK Technology Co.,Ltd.
A0916-SA105PVT
In Commercial Distribution

  • 06946725541234 ()


  • Tissue saturation oximeter sensor, reprocessed
GE Compatible Foam Disposable SpO2 sensor
APK Technology Co.,Ltd.
A2520-SN01
In Commercial Distribution

  • 06946725541227 ()


  • Tissue saturation oximeter sensor, reprocessed
Nellcor Oxi-Max Compatible,Adult Finger clip, 1.0M
APK Technology Co.,Ltd.
U4M03-01P
In Commercial Distribution

  • 06946725541197 ()


  • Tissue saturation oximeter sensor, reprocessed
Disposable Adult Nellcor Compatible D25
APK Technology Co.,Ltd.
S503-010
In Commercial Distribution

  • 06946725541180 ()
  • 16946725591601 ()


  • Tissue saturation oximeter sensor, reprocessed
Disposable Compatible Masimo LNOP Adult Box of 20
APK Technology Co.,Ltd.
S503-1250
In Commercial Distribution

  • 16946725591588 ()
  • 06946725541111 ()


  • Tissue saturation oximeter sensor, reprocessed
Nellcor Compatible Wrapping Separate, DB9(7pin) Reusable SpO2 Sensor
APK Technology Co.,Ltd.
A1418-SW203ME
In Commercial Distribution

  • 06946725541104 ()


  • Tissue saturation oximeter sensor, reprocessed
Nellcor Compatible Reusable Adult SPO2 Finger Sensor - Clip Style
APK Technology Co.,Ltd.
NE-DS100A-NC
In Commercial Distribution

  • 06946725541098 ()


  • Tissue saturation oximeter sensor, reprocessed
Mindray Compatible SpO2 Sensor, 9 Foot Cable: Adult Clip
APK Technology Co.,Ltd.
S410-220
In Commercial Distribution

  • 06946725541081 ()


  • Tissue saturation oximeter sensor, reprocessed
Nikon Kohden Compatible Adult Finger SPO2 Sensor
APK Technology Co.,Ltd.
10213
In Commercial Distribution

  • 06946725541050 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible SpO2 Sensor, 9 Foot Cable: Multi Site Sensor
APK Technology Co.,Ltd.
S810-080
In Commercial Distribution

  • 06946725541043 ()


  • Tissue saturation oximeter sensor, reprocessed
Nihon Kohden Compatible Disposable Adult Sensor TL-251T
APK Technology Co.,Ltd.
S503-160
In Commercial Distribution

  • 16946725591571 ()
  • 06946725541036 ()


  • Tissue saturation oximeter sensor, reprocessed
Mindray Compatible Direct-Connect SpO2 Adult Clip Sensor
APK Technology Co.,Ltd.
10501
In Commercial Distribution

  • 06946725541005 ()


  • Tissue saturation oximeter sensor, reprocessed
SpO2 Sensor, Pediatric Soft
APK Technology Co.,Ltd.
10244
In Commercial Distribution

  • 06946725540992 ()


  • Pulse Co-oximeter probe, reusable
Adult Finger SPO2 Sensor
APK Technology Co.,Ltd.
S410-68D0
In Commercial Distribution

  • 06946725540985 ()


  • Pulse Co-oximeter probe, reusable
Philips Compatible Masimo Compatible SpO2 Sensor Multi-Site
APK Technology Co.,Ltd.
S810-91M0
In Commercial Distribution

  • 06946725540978 ()


  • Tissue saturation oximeter sensor, reprocessed
M-tech compatible 14 Pin SpO2 Patient Cable 10 ft
APK Technology Co.,Ltd.
MAS-LNC-10
In Commercial Distribution

  • 06946725540954 ()


  • Tissue saturation oximeter sensor, reprocessed
M-Tech Compatible Adult Reusable Finger Clip sensor
APK Technology Co.,Ltd.
MAS-1863
In Commercial Distribution

  • 06946725540947 ()


  • Tissue saturation oximeter sensor, reprocessed
Nellcor Oximax Compatible SpO2 Sensor, Adult Clip, 9-Foot Cable
APK Technology Co.,Ltd.
S410-01P0
In Commercial Distribution

  • 06946725540916 ()


  • Tissue saturation oximeter sensor, reprocessed
M-Tech Compatible LNCS (2318, 1860) Pediatric Disposable SpO2 Sensor
APK Technology Co.,Ltd.
MAS-LNCS PDTX-NC
In Commercial Distribution

  • 06946725540909 ()


  • Tissue saturation oximeter sensor, reprocessed
M-Tech Compatible LNCS (2317, 1859) Adult Disposable SpO2 Sensor
APK Technology Co.,Ltd.
MAS-LNCS ADTX-NC
In Commercial Distribution

  • 06946725540893 ()


  • Tissue saturation oximeter sensor, reprocessed
M-Tech Compatible LNCS (2319, 2328) Infant SpO2 Disposable Sensor
APK Technology Co.,Ltd.
MAS-2319-NC
In Commercial Distribution

  • 06946725540886 ()


  • Tissue saturation oximeter sensor, reprocessed
Nonin Compatible Infant finger soft , DB9(7pin) Reusable SpO2 Sensor
APK Technology Co.,Ltd.
A1414-SI103PU
In Commercial Distribution

  • 06946725539507 ()


  • Pulse Co-oximeter probe, reusable
Nellcor Compatible Reusable SpO2 Sensor, Pediatric Finger Clip
APK Technology Co.,Ltd.
A1418-SP103MV
In Commercial Distribution

  • 06946725538715 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1414-SA103PV
In Commercial Distribution

  • 06946725538036 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1414-SA103PU
In Commercial Distribution

  • 06946725538029 ()


  • Pulse Co-oximeter probe, reusable
Masimo Compatible, Adult Finger Clip, 1.0M
APK Technology Co.,Ltd.
S403-490
In Commercial Distribution

  • 06946725530283 ()


  • Pulse Co-oximeter probe, reusable
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
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
Android
In Commercial Distribution

  • 04260749840046 ()


  • Self-care monitoring/reporting software
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
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
QuicklyPro-APP is a medical software that supports healthcare professionals, in general the physiotherapist, in managing the rehabilitation plan; in detail, it allows the patient at home to view and perform the exercises assigned to him by the physiotherapist, at the end of the exercises the results obtained are recorded and sent to the QP-Rehab platform where the physiotherapist can consult them.
QUICKLYPRO SRL
1.1.2
In Commercial Distribution

  • 08056999860035 ()


  • Biomechanical function analysis/rehabilitation software
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Libre Android App US
ABBOTT DIABETES CARE INC
78745-01
In Commercial Distribution

  • 00357599840006 ()
78745-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software
APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
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