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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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Scenium - 04056869950198

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431562
In Commercial Distribution

  • 04056869950198 ()


  • SPECT system application software
  • PET system application software

syngo MBF - 04056869279800

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431553
In Commercial Distribution

  • 04056869279800 ()


  • SPECT system application software
  • PET system application software

Ai-Rad Companion Prostate MR - 04056869274638

AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11545289
In Commercial Distribution

  • 04056869274638 ()


  • Radiology DICOM image processing application software

Samsung ECG Monitor Application - 08806090792045

No Description
Samsung Electronics Co., Ltd.
1.1
In Commercial Distribution

  • 08806090792045 ()


  • Electrocardiographic monitor

Samsung ECG Monitor Application - 08806090792021

No Description
Samsung Electronics Co., Ltd.
1.1
In Commercial Distribution

  • 08806090792021 ()


  • Electrocardiographic monitor

BoneMetrics US - 03770020839108

No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839108 ()


  • Radiological PACS software

TeraRecon Cardiac.Chambers.MR - CARDIACCHAMBERSMR1

This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
Terarecon Inc.
Cardiac.Chambers.MR01
In Commercial Distribution

  • CARDIACCHAMBERSMR1 ()
CARDIACCHAMBERSMR1

  • Radiology DICOM image processing application software

GI Genius - 10884521844544

GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution

  • 10884521844544 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit

GI Genius - 10884521844537

GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution

  • 10884521844537 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit

GI Genius - 10884521821545

Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution

  • 10884521821545 ()


  • Endoscopic video image interpretive unit
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