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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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IPS CaseDesigner 1.2 for MAC
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747125009 ()
300011

  • Dental treatment application software
IPS CaseDesigner 1.2 for Windows 64-bit
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747124996 ()
300011

  • Dental treatment application software
Software, TomoApps, Version 5.1.3 Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
ACCURAY INCORPORATED
1062424
In Commercial Distribution

  • M65810624240 ()
NA

  • Linear accelerator system
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5736744
In Commercial Distribution

  • 04049098053808 ()


  • Patient monitoring system module, electroencephalographic
A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution

  • 06430056480022 ()


  • Electroencephalograph
The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300152
In Commercial Distribution

  • 00860183001528 ()


  • Stereotactic radiosurgery/radiation therapy linear accelerator system
The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300151
In Commercial Distribution

  • 00860183001511 ()


  • Stereotactic radiosurgery/radiation therapy linear accelerator system
BrainSpec Core™ Software is a web-based software platform that allows for the interpretation of magnetic spectroscopy data to display relative levels of brain metabolites.
BrainSpec Inc.
BrainSpec Core™ Software
In Commercial Distribution

  • 00860013965204 ()


  • Radiological PACS software
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