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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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GE Client Workstation - 00840682123594

SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

PillCam - 10884521845923

PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software

AVEA - 10846446064865

KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software

Somnostar - 10846446032550

SWR KIT SSPRO SOFTWARE VER 11
Carefusion Corporation
28008-001
Not in Commercial Distribution

  • 10846446032550 ()
28008-001

  • Home-use sleep apnoea recording system

Somnostar - 10846446031485

SWR KIT SSPRO SOFTWARE VER 10.2
Carefusion Corporation
22312-001
Not in Commercial Distribution

  • 10846446031485 ()
22312-001

  • Home-use sleep apnoea recording system

Vmax - 10846446027693

SOFTWARE KIT VMAX ENCORE VER 21-1
Carefusion Corporation
63792
Not in Commercial Distribution

  • 10846446027693 ()
63792

  • Pulmonary function analysis system, adult
  • Pulmonary function analysis system, paediatric

BD Pyxis - 10885403513725

BD Pyxis CIISafe (Software v9.X)
CAREFUSION 303, INC.
SW-CII-SAFE-V9
In Commercial Distribution

  • 10885403513725 ()


  • Anaesthesia cabinet

CoroFlow Upgrade kit - 07350111070663

Software upgrade for Coroventis CoroFlow System
COROVENTIS Research AB
12000-20
In Commercial Distribution

  • 07350111070663 ()


  • Cardiac catheterization laboratory computer

Aurora Xi Plasmapheresis System - 00810020440898

Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

Vita CR System - 60889971919878

IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner

PillCam - 07290110360214

PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software

Site~Rite 8 Ultrasound System - 00801741225895

Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution

  • 00801741225895 ()
SR8v3.0.1

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219436

Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution

  • 00801741219436 ()
Sherlockv3.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic

Site~Rite 8 Ultrasound System - 00801741219382

Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution

  • 00801741219382 ()
SR8v2.3.1

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219344

Site~Rite 8 Host System Software
Bard Access Systems, Inc.
SR8v2.2.0
In Commercial Distribution

  • 00801741219344 ()
SR8v2.2.0

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219252

Site~Rite 8 Ultrasound Application Software
Bard Access Systems, Inc.
SR8 USv2.2.0
In Commercial Distribution

  • 00801741219252 ()
SR8 USv2.2.0

  • General-purpose ultrasound imaging system

Sherlock 3CG+ TCS - 00801741188718

Sherlock 3CG+ TCS Software Version 3.1.0
Bard Access Systems, Inc.
Sherlock 3CG+ TCS Software Version 3.1.0
In Commercial Distribution

  • 00801741188718 ()
Sherlock 3CG+ TCS Software Version 3.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic

Site~Rite 8 - 00801741121449

Site~Rite 8 Ultrasound System Software
Bard Access Systems, Inc.
SR8v1.0.3
In Commercial Distribution

  • 00801741121449 ()
SR8v1.0.3

  • General-purpose ultrasound imaging system

N/A - 00763000975029

SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer

VULCAN - 03596010612793

PCMCIA CARD SOFTWARE VERSION 3.71 VULC
Smith & Nephew, Inc.
72201356
In Commercial Distribution

  • 03596010612793 ()
72201356

  • Radio-frequency ablation system

Q-Tel RMS - 00817655020105

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-001-70
In Commercial Distribution

  • 00817655020105 ()


  • Electrocardiography telemetric monitoring system

Q-Tel RMS - 00817655021447

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-006-70
In Commercial Distribution

  • 00817655021447 ()


  • Electrocardiography telemetric monitoring system

Q-Tel RMS - 00817655021430

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-005-70
In Commercial Distribution

  • 00817655021430 ()


  • Electrocardiography telemetric monitoring system

UNITRON - 07613389221589

TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software

UNITRON - 07613389221572

TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software

HANSATON - 07613389143232

USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software

HANSATON - 07613389143225

DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software

Phadia Information Data Manager Software Package - 07333066001012

Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution

  • 07333066001012 ()
12-3801-11

  • Laboratory instrument/analyser application software IVD

OrthoNext™ Platform System Software - 18052469476444

POSTOPERATIVE TLHEX MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469476444 ()
TLHEXMODULESW

  • Radiological PACS software

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

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

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

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
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