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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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InPen Smart Insulin Delivery System - 00763000489953

SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical

Cytomics FC500 - 15099590572839

Cytomics FC 500 with CXP Software
Beckman Coulter, Inc.
UPS (CXP)
In Commercial Distribution

  • 15099590572839 ()
626553

  • Flow cytometry analyser IVD, semi-automated

InPen Smart Insulin Delivery System - 00763000489960

SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000489960 ()


  • Empty self-injector, mechanical

Werewolf - 00885556692516

WEREWOLF MAIN SOFTWARE UPGRADE V. 2.5-1.4
Smith & Nephew, Inc.
72290133
In Commercial Distribution

  • 00885556692516 ()
72290133

  • Electrosurgical system generator

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit

VITEK®2 - 03573026553968

VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution

  • 03573026553968 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

360CAS - B432360CAS2100

360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.1.0
In Commercial Distribution

  • B432360CAS2100 ()


  • Robotic surgical navigation system application software

Koios DS - 00860002545714

Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution

  • 00860002545714 ()


  • Ultrasound imaging system application software

NeuroMatch - 00850056774000

NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution

  • 00850056774000 ()


  • Bioelectrical signal analysis software

Persyst 15 EEG Review and Analysis Software - 00869732000166

Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P15
In Commercial Distribution

  • 00869732000166 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000142

This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000135

The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software

Persyst 14 Review and Analysis Software - 00869732000128

Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P14
In Commercial Distribution

  • 00869732000128 ()


  • Bioelectrical signal analysis software

Persyst 13 EEG Review and Analysis Software - 00869732000111

Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P13
In Commercial Distribution

  • 00869732000111 ()


  • Bioelectrical signal analysis software

Persyst 12 EEG Review and Analysis Software - 00869732000104

Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P12
In Commercial Distribution

  • 00869732000104 ()


  • Bioelectrical signal analysis software

Natus - 00382830058575

IP Alarm Relay Box accessory kit
XLTEK
024006
In Commercial Distribution

  • 00382830058575 ()


  • Electroencephalograph

Natus - 00382830058216

Patient Room Alarm Relay Box (IP Version)
XLTEK
023019
In Commercial Distribution

  • 00382830058216 ()


  • Electroencephalograph

Natus - 00382830058209

IP Alarm Controller, Box
XLTEK
022979
In Commercial Distribution

  • 00382830058209 ()


  • Electroencephalograph

encevis - 09120109830078

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software

encevis - 09120109830122

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software

NA - 00840682104272

No Description
GE Healthcare Finland Oy
E-ENTROPY-01
In Commercial Distribution

  • 00840682104272 ()


  • Patient monitoring system module, electroencephalographic

OmniME - 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

Radixact®, Treatment Delivery Console (TDC) - M65810565930

Software, Version 1.0.0.3, Treatment Delivery Console (TDC), Radixact (Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1056593
In Commercial Distribution

  • M65810565930 ()
NA

  • Linear accelerator system

Radixact®, Treatment Delivery Console - M65810554870

Software, Version 1.0.0.2, Treatment Delivery Console, Radixact Version 1.0.0.2 (Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1055487
In Commercial Distribution

  • M65810554870 ()
NA

  • Linear accelerator system

Radixact®, Treatment Delivery Console (TDC) - M65810502410

Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact (Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1050241
In Commercial Distribution

  • M65810502410 ()
NA

  • Linear accelerator system

Brainlab Elements Fibertracking - 04056481142186

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481142186 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion - 04056481140816

No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481140816 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion Angio - 04056481138530

No Description
Brainlab AG
1.0
In Commercial Distribution

  • 04056481138530 ()


  • Radiological PACS software
  • Stereotactic system application software

Widex - 05706069659788

Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Widex A/S
B-F2
In Commercial Distribution

  • 05706069659788 ()
8 393 0101 112

  • Hearing aid remote control application software

Automated Wound Measurements - 00860475000383

No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution

  • 00860475000383 ()


  • Wound management image-analysis software
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