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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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Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation
BD Pyxis MedBank Tower (Cabinet CR Software v3.X)
CAREFUSION 303, INC.
SW-MB-CR-V3
In Commercial Distribution

  • 10885403513800 ()


  • Anaesthesia cabinet
EMG v20/v21 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630400
In Commercial Distribution

  • 00382830045087 ()


  • Electromyograph
Natus Elite v2 Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
688-630200
In Commercial Distribution

  • 00382830062251 ()


  • Electromyograph
Care Orchestrator Essence, Medical equipment clinical data interfacing software
Respironics, Inc.
4.0.0
In Commercial Distribution

  • 00606959062863 ()
1135709

  • Medical equipment clinical data interfacing software
Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor
Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.8 (Cloud)
In Commercial Distribution

  • 00850005944553 ()
83-00090-000

  • Magnetic neural stimulation system
Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.8 (Local)
In Commercial Distribution

  • 00850005944447 ()
83-00091-000

  • Magnetic neural stimulation system
Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Cloud)
In Commercial Distribution

  • 00850005944133 ()
83-00060-000

  • Magnetic neural stimulation system
Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Cloud)
In Commercial Distribution

  • 00850005944126 ()
83-00060-000

  • Magnetic neural stimulation system
Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Local)
In Commercial Distribution

  • 00850005944102 ()
83-00056-000

  • Magnetic neural stimulation system
Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Local)
In Commercial Distribution

  • 00850005944096 ()
83-00056-000

  • Magnetic neural stimulation system
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-08
In Commercial Distribution

  • 00811505030467 ()
LVP-SW

  • Bedside infusion pump, single-channel
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-07
In Commercial Distribution

  • 00811505030436 ()
LVP-SW

  • Bedside infusion pump, single-channel
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
In Commercial Distribution

  • 00811505030375 ()
LVP-SW

  • Bedside infusion pump, single-channel
Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
Not in Commercial Distribution

  • 00811050530375 ()
LVP-SW

  • Bedside infusion pump, single-channel
EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software Dongle Only, 12 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020221 ()
A10-0118-12

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software & Dongle, 12 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020214 ()
A10-0118-10

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software Dongle Only, 3 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020207 ()
A10-0118-02

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020177 ()
A10-0118-00

  • Electrocardiographic long-term ambulatory recording analyser application software
CB Series Analysis & Reporting Software - 3 & 12 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020139 ()
A10-0031

  • Electrocardiographic long-term ambulatory recording analyser application software
Application- Bio-Impendence Analysis software used for determining Body Composition
IMPEDIMED LIMITED
1.1.0
Not in Commercial Distribution

  • B277SOZOPRO0 ()
SOZOpro

  • Bioelectrical body composition analyser
Sherlock 3GC Diamond TCS on Site~Rite 8 Software
Bard Access Systems, Inc.
Sherlockv1.1.2
In Commercial Distribution

  • 00801741121470 ()
Sherlockv1.1.2

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software for MicronMapper and MicronMapper EVO Dental Metrology Systems
Claronav Inc
990-MM1-INST-WIN
In Commercial Distribution

  • 07540209956232 ()


  • Dental milling system, CAD/CAM, laboratory
Stellaris Elite PC with Laser with Version 5+ Software
Bausch & Lomb Incorporated
BL15455
In Commercial Distribution

  • 00757770524532 ()
BL15455

  • Phacoemulsification/vitrectomy system
Stellairs Elite PC Combined System with Version 5+ Software
Bausch & Lomb Incorporated
BL14455
In Commercial Distribution

  • 00757770524525 ()
BL14455

  • Phacoemulsification/vitrectomy system
No Description
ULTROMICS LIMITED
Amyloidosis 1.0
In Commercial Distribution

  • 05060634690065 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
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