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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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Burn Navigator - B2551120

Burn Navigator H2 model
ARCOS, INC.
H2
In Commercial Distribution

  • B2551120 ()
1120

  • Clinical information system web-based application software

VITEK®2 - 03573026609399

CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit - 00854624006005

No Description
IVD RESEARCH, INC.
C/G-DFA
In Commercial Distribution

  • 00854624006005 ()
C/G-DFA

  • Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
  • Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)

Widex - 05706069659788

Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Widex A/S
B-F2
In Commercial Distribution

  • 05706069659788 ()
8 393 0101 112

  • Hearing aid remote control application software

Norav 1200 Series PC-ECG - 07290110252809

Norav 1200 Series PC-ECG Software Kit for COSMED 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 - I1 = Resting-ECG Measurement - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1-D1
In Commercial Distribution

  • 07290110252809 ()
HASP-SW-K-S2I1D1-01

  • Cardiopulmonary stress exercise monitoring system computer
  • Cardiovascular risk evaluation interpretive software
  • Patient-administration information system application software

BioSticker™ System Offload Software - 00850005949046

Offload Software for the BioSticker System.
BIOINTELLISENSE, INC.
SWDT10001-1.1.1
In Commercial Distribution

  • 00850005949046 ()


  • Electrocardiography telemetric monitoring system transmitter

660 - 03596010579591

CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system

VITEK® 2 KB UPDATE V2S - 03573026613914

Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.03
In Commercial Distribution

  • 03573026613914 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

Cardiostation Premier Stand Alone Software - B147CSS0

Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system

Cardiostation® Advantage Software - B147CA0

Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution

  • B147CA0 ()


  • Electrocardiography telemetric monitoring system
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