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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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n/a - 04961333231409

CD, 3650 VER. 3.4.1, REV.F
PENTAX OF AMERICA, INC.
7187-7400
In Commercial Distribution

  • 04961333231409 ()


  • Electroglottograph

n/a - 04961333231379

CD, 4337 VOICE DISORDS DATABA
PENTAX OF AMERICA, INC.
7183-1400
In Commercial Distribution

  • 04961333231379 ()


  • Electroglottograph

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

Welch Allyn, Inc. - 00817655023106

QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor

FLUOROMAP - 07613252196259

FLUOROMAP 1.0 - SALES DEMO CD
Stryker Leibinger GmbH & Co. KG
81-81022
In Commercial Distribution

  • 07613252196259 ()
81-81022

  • Robotic surgical navigation system application software

N/A - 00885074017082

SFTWR 9731368 CD, AUTO-INSTALL, TRACER
MEDTRONIC NAVIGATION, INC.
9731368
In Commercial Distribution

  • 00885074017082 ()


  • Multi-purpose stereotactic surgery system

Welch Allyn, Inc. - 00732094307351

QTEL v5.0.1 TOWER SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307351 ()
419751

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307375

Q-TEL V5.0.1 Q-PROGRESS SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307375 ()
419733

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307368

Q-TEL V5.0.1 Workstation Software CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307368 ()
413379

  • Centralized patient monitor

SOLERA - 00763000927110

TAPS 9735469 CD HORIZON SOLERA
MEDTRONIC NAVIGATION, INC.
9735469
In Commercial Distribution

  • 00763000927110 ()


  • Multi-purpose stereotactic surgery system
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