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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 - B2551125

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

  • B2551125 ()
1125

  • Clinical information system web-based application software

Burn Navigator - B2551120

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

  • B2551120 ()
1120

  • Clinical information system web-based 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

Xltek - 00382830023924

Sandman Codec Software V.2.0 CD-Elite
Embla Systems Ltd
4120082
In Commercial Distribution

  • 00382830023924 ()


  • Sleep disorder interpretive software

660 - 03596010579591

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

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system

VULCAN - 03596010612793

PCMCIA CARD SOFTWARE VERSION 3.71 VULC
Smith & Nephew, Inc.
72201356
In Commercial Distribution

  • 03596010612793 ()
72201356

  • Radio-frequency ablation 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

Q-Tel RMS - 00817655021447

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-006-70
In Commercial Distribution

  • 00817655021447 ()


  • Electrocardiography telemetric monitoring system
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