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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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YO Home Sperm Test - 07290016650112

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Iphone 6 plus/ 6s plus/ 7 plus
In Commercial Distribution

  • 07290016650112 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

YO Home Sperm Test - 07290016650105

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7 Edge
In Commercial Distribution

  • 07290016650105 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

YO Home Sperm Test - 07290016650082

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7
Not in Commercial Distribution

  • 07290016650082 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

YO Home Sperm Test - 07290016650075

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 6
In Commercial Distribution

  • 07290016650075 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

YO Home Sperm Test - 07290016650068

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 7
In Commercial Distribution

  • 07290016650068 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

YO Home Sperm Test - 07290016650051

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 6
In Commercial Distribution

  • 07290016650051 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

CLEWICU - 07290018852002

No Description
CLEW MEDICAL LTD
4.8
In Commercial Distribution

  • 07290018852002 ()


  • Clinical management support software

INTELLIO Tablet - 00885556813683

INTELLIO TABLET
Smith & Nephew, Inc.
72205455
In Commercial Distribution

  • 00885556813683 ()
72205455

  • Operating room audiovisual data/device management system application software

DIGITAL DIAGNOSTICS SYSTEM - 15420045517585

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517585 ()
ASY-17964

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045517097

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517097 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045515062

Computer to operate the ThinPrep® Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045515062 ()
CMP-01836

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045514201

Medical grade Genius™ Review Station monitor for use with the Genius™ Digital Diagnostics System.
Hologic, Inc.
DISPLAY, 27IN, 8MP
In Commercial Distribution

  • 15420045514201 ()
CMP-01669

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512535

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512511

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512511 ()
CMP-01667

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045508163

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD

SecurView DX Manager - 15420045507388

The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations.
Hologic, Inc.
SVDX Manager
In Commercial Distribution

  • 15420045507388 ()
SVDX-00600-HIRES

  • Laboratory instrument/analyser application software IVD

SecurViewRT Manager - 15420045507371

The SecurView® RT technologist workstation Manager provides central database access and performs the image preparation for all connected SecurView RT Client workstations.
Hologic, Inc.
SVRT Manager
In Commercial Distribution

  • 15420045507371 ()
SVRT-00600R

  • Laboratory instrument/analyser application software IVD

SecurViewRT Mammorgraphy Workstation - 15420045507364

The SecurView® RT technologist workstation is intended to be used by technologists to view images durign screening and diagnostic exams.
Hologic, Inc.
SVRT
In Commercial Distribution

  • 15420045507364 ()
SVRT-00300

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507265

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705145

Kaluza C 10 User Network Educational License
Beckman Coulter, Inc.
10 User Network Educational License
In Commercial Distribution

  • 15099590705145 ()
C10580

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705121

Kaluza C Perpetual Education License
Beckman Coulter, Inc.
Perpetual Education License
In Commercial Distribution

  • 15099590705121 ()
C10578

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705107

Kaluza C 10 User Network
Beckman Coulter, Inc.
10 User Network
In Commercial Distribution

  • 15099590705107 ()
C10577

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705084

Kaluza C Perpetual License
Beckman Coulter, Inc.
Perpetual License
In Commercial Distribution

  • 15099590705084 ()
C10574

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045513914

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045513914 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045513716

Computer to operate the ThinPrep® Integrated Imager.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045513716 ()
CMP-01764

  • Laboratory instrument/analyser application software IVD

LENS CONNECTED TOWER APPLICATION - 00885556778777

LENS CONNECTED TOWER APPLICATION
Smith & Nephew, Inc.
72205347
In Commercial Distribution

  • 00885556778777 ()
72205347

  • Operating room audiovisual data/device management system application software

INTEllIO LINK WEREWOLF - 00885556741641

INTELLIO LINK WEREWOLF
Smith & Nephew, Inc.
72205191
In Commercial Distribution

  • 00885556741641 ()
72205191

  • Operating room audiovisual data/device management system application software

LINK DOUBLEFLOW PUMP - 00885556741634

LINK DOUBLEFLO PUMP
Smith & Nephew, Inc.
72205190
In Commercial Distribution

  • 00885556741634 ()
72205190

  • Operating room audiovisual data/device management system application software

INTELLIO LINK Dyonics Power II - 00885556741627

INTELLIO LINK DYONICS POWER II
Smith & Nephew, Inc.
72205189
In Commercial Distribution

  • 00885556741627 ()
72205189

  • Operating room audiovisual data/device management system application software

ThinPrep Imaging System - 15420045508040

Automated cytology review microscope with ThinPrep® slide imaging functionality.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045508040 ()
ASY-07233

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507258

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507258 ()
CMP-01515

  • Laboratory instrument/analyser application software IVD

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD

MULTIVIEW - 15420045504684

MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD

SecurView Diagnostic Workstation - 15420045504523

The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis.
Hologic, Inc.
SecurView DX
In Commercial Distribution

  • 15420045504523 ()


  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504103

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504103 ()
ASY-08346

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504097

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504097 ()
ASY-06281

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504080

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504080 ()
ASY-06284

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504042

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504035

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504035 ()
CMP-01284

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501041

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501034

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
Not in Commercial Distribution

  • 15420045501034 ()
ASY-03446

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500990

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500990 ()
CMP-00815

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500983

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500983 ()
71278-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500976

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500976 ()
71964-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500945

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500945 ()
71074-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500938

A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500938 ()
71050-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500921

A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500921 ()
70564-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500914

A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500914 ()
ASY-06042

  • Laboratory instrument/analyser application software IVD

MicroScan - 15099590793005

DVD, LabPro V4_V5 Maintenance Update 05
Beckman Coulter, Inc.
V4_V5
In Commercial Distribution

  • 15099590793005 ()
  • 15099590792930 ()
D12428

  • Laboratory instrument/analyser application software IVD

MicroScan - 15099590792923

LabPro V4_V5 Maintenance Update 05 (US), Electronic
Beckman Coulter, Inc.
V4_V5
In Commercial Distribution

  • 15099590792923 ()
D12427

  • Laboratory instrument/analyser application software IVD
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