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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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X EP System AutoMark Distance Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AMD-01
In Commercial Distribution

  • 05415067048363 ()
ENSITE-D-AMD-01

  • Cardiac mapping system application software
Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.
ELECTRICAL GEODESICS, INC.
GeoSource 2.0
Not in Commercial Distribution

  • 00863003000343 ()


  • Electroencephalograph
VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.3
In Commercial Distribution

  • 09421904268098 ()


  • Radiology DICOM image processing application software
Software for biopsy needle guide planning and tracking.
Medical Targeting Technologies GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software
Siesta 802 Basic EEG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic EEG System
In Commercial Distribution

  • 09342451002112 ()
9007-0061-01

  • Electroencephalographic ambulatory recorder
Siesta 802 Basic PSG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic PSG System
In Commercial Distribution

  • 09342451001788 ()
9007-0060-00

  • Polysomnograph
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software
EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished)
ECHONOUS, INC.
R007635
In Commercial Distribution

  • 09353278000670 ()


  • Hand-held ultrasound imaging system, body-surface
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
In Commercial Distribution

  • 04012030022910 ()
1252000030

  • Medical equipment clinical data interfacing software
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030021678 ()
1252000020

  • Medical equipment clinical data interfacing software
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030020794 ()
1252000012

  • Medical equipment clinical data interfacing software
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030020503 ()
1252000010

  • Medical equipment clinical data interfacing software
BioPlex 2200 System Operation Manual , Software Version 4.3
BIO-RAD LABORATORIES, INC.
SW Version 4.3
In Commercial Distribution

  • 03610520540633 ()

  • 1 EA
12000958

  • Fluorescent immunoassay analyser IVD, laboratory
BioPlex 2200 System Operation Manual , Software Version 4.2
BIO-RAD LABORATORIES, INC.
SW Version 4.2
In Commercial Distribution

  • 03610520505915 ()

  • 1 EA
6600813-4.2.1

  • Fluorescent immunoassay analyser IVD, laboratory
Medical software used for oximetry analysis and reporting.
APNEICARE, LLC
CCIA
In Commercial Distribution

  • G642CC1A0 ()


  • Medical equipment clinical data interfacing software
Software Module for RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-104918
In Commercial Distribution

  • H7877001049180 ()
  • 15051684021876 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
LABSYSTEM™ PRO EP Review Workstation Software, V2.7
BOSTON SCIENTIFIC CORPORATION
M00420020300
In Commercial Distribution

  • 08714729884002 ()


  • Cardiopulmonary physiological parameter analysis software
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.1
In Commercial Distribution

  • B9875X10 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.0
Not in Commercial Distribution

  • B9875X00 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
4.0
Not in Commercial Distribution

  • B9874X00 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.4
Not in Commercial Distribution

  • B9873X40 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.3
Not in Commercial Distribution

  • B9873X30 ()


  • Accelerator system quality assurance device
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
VIDAS PC V4.9 W10 Software version for clinic
BIOMERIEUX SA
4.9
In Commercial Distribution

  • 03573026619527 ()


  • Fluorescent immunoassay analyser IVD, laboratory
FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
SIRONA DENTAL, INC.
B1035106
In Commercial Distribution

  • D764B10351060 ()


  • Diagnostic x-ray digital imaging system workstation application software
BD Pyxis MedBank Tower (MedPass Software v1.X)
CAREFUSION 303, INC.
SW-MP-V1
In Commercial Distribution

  • 10885403513817 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station 4000 (Software v6.X)
CAREFUSION 303, INC.
SW-PAS-4000-V6
In Commercial Distribution

  • 10885403513787 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station ES (Software v2.X)
CAREFUSION 303, INC.
SW-PAS-ES-V2
In Commercial Distribution

  • 10885403513770 ()


  • Anaesthesia cabinet
ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL"
Gimmi GmbH
S.2046.60 HD
In Commercial Distribution

  • 04049047653516 ()
S.2046.60 HD

  • Endoscopic video imaging system
Software unitary component (common to hip and knee)
Omni Life Science, Inc.
TOOL 14-020
In Commercial Distribution

  • 00841690194019 ()
TOOL 14-020

  • Robotic surgical navigation system application software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.22
In Commercial Distribution

  • 00606959056909 ()
1126366

  • Medical equipment clinical data interfacing software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.21
In Commercial Distribution

  • 00606959056329 ()
1126366

  • Medical equipment clinical data interfacing software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.20
In Commercial Distribution

  • 00606959056084 ()
1126366

  • Medical equipment clinical data interfacing software
EMG v22 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630300
In Commercial Distribution

  • 00382830045070 ()


  • Electromyograph
BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical Flow Cytometry Software v1.3
Becton, Dickinson And Company
663003
In Commercial Distribution

  • 00382906630032 ()
663003

  • Laboratory instrument/analyser application software IVD
Software Kit for SVM-7200 Series Vital Signs Monitor
NIHON KOHDEN CORPORATION
QS-126P
In Commercial Distribution

  • 04931921006054 ()
QS-126P

  • General-purpose multi-parameter bedside monitor
PC Software for BP Unit,w/USB Cable
AMERICAN DIAGNOSTIC CORP
6017PC
Not in Commercial Distribution

  • 00634782058470 ()
6017PC

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
PC Software for Digital BP,w/USB Cable
AMERICAN DIAGNOSTIC CORP
6023NPC
In Commercial Distribution

  • 00634782075941 ()
6023NPC

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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