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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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Norav 1200 Series PC-ECG - 07290110252786

Norav 1200 Series PC-ECG Software Upgrade Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2toS2
In Commercial Distribution

  • 07290110252786 ()
HASP-SW-K-S2-S1-01

  • Cardiopulmonary stress exercise monitoring system computer

MUCheck® - 00860175002403

MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution

  • 00860175002403 ()


  • Radiation therapy software

CARES Chairside Software - 07630031738820

No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738820 ()
019.2033

  • Dental milling system, CAD/CAM, chairside

CARES Visual Software - 07630031738813

No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738813 ()
019.2032

  • Dental milling system, CAD/CAM, laboratory

MobiTrak Software v3.00 - B292M9170810

No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system

U400 ImpSoft Software - B277292U400CD0

Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser

CAS-One IR Software - 07616962000250

No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation

isoPoint Validation Software - B3658080000

Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.
Aktina Corp.
80-800
In Commercial Distribution

  • B3658080000 ()


  • Accelerator system quality assurance device

PinPoint Autoregistration Software - B365501350

No Description
Aktina Corp.
50-135
In Commercial Distribution

  • B365501350 ()


  • Stereotactic system application software

VERASENSE Software Application - 07613327581843

No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit
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