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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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EnSite™ - 05415067050281

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067048394

X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software

EnSite™ - 05415067048370

X EP System Averaged Impedance Drop Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-IMP-01
In Commercial Distribution

  • 05415067048370 ()
ENSITE-D-IMP-01

  • Cardiac mapping system application software

EnSite™ - 05415067047861

X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

Eko Mobile App iOS - 00863609000334

iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software

AngioDynamics - H7877001059370

Software Module (RoHS Compliant) RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-105937
In Commercial Distribution

  • H7877001059370 ()
  • 15051684025867 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

AngioDynamics - H7877001057400

Japanese Software Module for RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-105740
Not in Commercial Distribution

  • H7877001057400 ()
  • 15051684026253 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

Philips Sonicare - 08710103988984

Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush

Philips Sonicare - 08710103988977

Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush

SICAT Function - D77664556410

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 - 10885403513800

BD Pyxis MedBank Tower (Cabinet CR Software v3.X)
CAREFUSION 303, INC.
SW-MB-CR-V3
In Commercial Distribution

  • 10885403513800 ()


  • Anaesthesia cabinet

Natus - 00382830045087

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

  • 00382830045087 ()


  • Electromyograph

Natus - 00382830062251

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

  • 00382830062251 ()


  • Electromyograph

Care Orchestrator Essence - 00606959062863

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 - 09120073931931

Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor

TrakStar Patient Data Management System Software - 00850005944553

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

TrakStar Patient Data Management System Software - 00850005944447

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

TrakStar Patient Data Management System Software - 00850005944133

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

TrakStar Patient Data Management System Software - 00850005944126

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
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