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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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Patient Transmitter Software
ST. JUDE MEDICAL, INC.
LSRM1000
In Commercial Distribution

  • 05415067049971 ()
LSRM1000

  • Transtelephonic implantable pacemaker analysis system
Media Writer Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007129 ()


  • Radiology DICOM image processing application software
Gearview QC Software
HYLAND LLC
2
In Commercial Distribution

  • 00850677007051 ()


  • Radiological PACS software
PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner
Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer
Dosimetry QA Software
VARIAN MEDICAL SYSTEMS, INC.
6.8.0
Not in Commercial Distribution

  • 00861334000339 ()
DoseLab Pro

  • Accelerator system quality assurance device
PMD Viewer Software
Spencer Technologies
PMD Viewer
In Commercial Distribution

  • 00862726000326 ()
12143

  • Radiology DICOM image processing application software
3D visualization software
CURVEBEAM, LLC
3.7.0
In Commercial Distribution

  • 00863152000379 ()


  • Radiology DICOM image processing application software
3D visualization software
CURVEBEAM, LLC
3.6.0
In Commercial Distribution

  • 00863152000362 ()


  • Radiology DICOM image processing application software
SOFTWARE CONNEXX 9.11
Ws Audiology Usa, Inc.
Connexx 9.11
In Commercial Distribution

  • 05714880200003 ()
21026507

  • Audiometric/hearing device software
SOFTWARE CONNEXX 9.9
Ws Audiology Usa, Inc.
Connexx 9.9
In Commercial Distribution

  • 05714880182354 ()
21022254

  • Audiometric/hearing device software
SOFTWARE CONNEXX 9.8
Ws Audiology Usa, Inc.
Connexx 9.8
In Commercial Distribution

  • 05714880169393 ()
21016993

  • Audiometric/hearing device software
SOFTWARE COMPASS CLOUD
Widex A/S
Widex Compass Cloud
In Commercial Distribution

  • 05714880207750 ()
21028348

  • Audiometric/hearing device software
PCH100 STANDALONE SOFTWARE
WELCH ALLYN, INC.
901052
In Commercial Distribution

  • 00732094128482 ()
704525

  • Electrocardiograph, professional, multichannel
Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system
Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis software
Hearing implant software
COCHLEAR LIMITED
v7.1, US
In Commercial Distribution

  • 09321502072359 ()
P1947519

  • Audiometric/hearing device software
Hearing implant software
COCHLEAR LIMITED
v 2.0
In Commercial Distribution

  • 09321502070416 ()
P1986795

  • Cochlear implant intraoperative electrophysiological analysis software
Data Manager Software
Dexcom, Inc.
350-0011
Not in Commercial Distribution

  • 00038270000451 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
Modality Worklist Software
KOVEN TECHNOLOGY, INC.
2.0
In Commercial Distribution

  • 00894912002067 ()
PAUS2.0

  • Radiology information system application software
EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software
Protura Software Manual
MEDTEC, INC.
MT6XSM1.6.0
Not in Commercial Distribution

  • 00841439102930 ()

  • Width: 8.5 Inch
  • Length: 11 Inch
MT6XSM1.6.0

  • Indexed-immobilization patient positioning system
sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software
Connect 4.5.0 Software
SIRONA Dental Systems GmbH
6620780
In Commercial Distribution

  • E27666207800 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC 4.4.4 Software
SIRONA Dental Systems GmbH
6613009
In Commercial Distribution

  • E27666130090 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Connect 4.4.4 Software
SIRONA Dental Systems GmbH
6610468
In Commercial Distribution

  • E27666104680 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC 4.5.0 Software
SIRONA Dental Systems GmbH
6610450
In Commercial Distribution

  • E27666104500 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
inLab 16.0 Software
SIRONA Dental Systems GmbH
6610427
In Commercial Distribution

  • E27666104270 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
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