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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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Knee Software Package, ART 2.2 Add-on
Omni Life Science, Inc.
NS-27009
In Commercial Distribution

  • 00841690194514 ()
NS-27009

  • Instrument tray, reusable
CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system
Lilivis CAD L-CAD (Chairside CAD Software)
Huvitz Co., Ltd.
L-CAD
In Commercial Distribution

  • 08800019600909 ()
LS-100

  • CAD/CAM software
Monarch™ Laptop P16 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811527 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811510 ()


  • Robotic surgical system application software
Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software
Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.04
In Commercial Distribution

  • 03573026626471 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
PGDx elio™ tissue complete software
PERSONAL GENOME DIAGNOSTICS INC.
B01103200
In Commercial Distribution

  • 00192721000770 ()
B01103200

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
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