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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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QUANTIEN™ - 05415067000996

Diagnostic Computer
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067000996 ()
C12787

  • Cardiac catheterization laboratory computer

N/A - 04961333241989

COMPUTER ACCESSORIES
PENTAX OF AMERICA, INC.
68403-ACC
In Commercial Distribution

  • 04961333241989 ()


  • Computer terminal

N/A - 04961333241972

COMPUTER ACCESSORIES
PENTAX OF AMERICA, INC.
68391-ACC
In Commercial Distribution

  • 04961333241972 ()


  • Computer terminal

N/A - 04961333241965

LAPTOP COMPUTER
PENTAX OF AMERICA, INC.
4307-1
In Commercial Distribution

  • 04961333241965 ()


  • Electroglottograph

RIO - 00848486021702

LAPTOP COMPUTER
MAKO SURGICAL CORP.
203866
In Commercial Distribution

  • 00848486021702 ()
203866

  • Robotic surgical navigation system

X-GUIDE - 00817421020711

COMPUTER MOUSE
XNAV TECHNOLOGIES LLC
P008697
In Commercial Distribution

  • 00817421020711 ()
P008697

  • Surgical planning/navigation-enhancement system

N/A - 00643169188174

COMPUTER 945NCCPU NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPU
In Commercial Distribution

  • 00643169188174 ()


  • Nerve-locating system

NIM-Eclipse® - 00643169438187

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00643169438187 ()


  • Nerve-locating system

N/A - 00643169438170

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00643169438170 ()


  • Portable computer

EP-4™ - 05414734219112

Touch Screen Computer
ST. JUDE MEDICAL, INC.
H21911
In Commercial Distribution

  • 05414734219112 ()
H21911

  • Cardiac electrophysiology stimulation system
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