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

  • 00643169438170 ()


  • Portable computer
LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M00420020810
In Commercial Distribution

  • 08714729996934 ()
M00420020810

  • General-purpose multi-parameter bedside monitor
LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M0042002081D0
In Commercial Distribution

  • 08714729996927 ()
M0042002081D0

  • General-purpose multi-parameter bedside monitor
LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M0042002081H0
In Commercial Distribution

  • 08714729996910 ()
M0042002081H0

  • General-purpose multi-parameter bedside monitor
LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M0042002081R0
In Commercial Distribution

  • 08714729996903 ()
M0042002081R0

  • General-purpose multi-parameter bedside monitor
ARVIS Computer Module
KICO KNEE INNOVATION COMPANY PTY LIMITED
12700
In Commercial Distribution

  • 00850012315254 ()


  • Orthopaedic stereotactic surgery system
COMPUTER 945NWCPU DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPU
In Commercial Distribution

  • 00643169071957 ()


  • Nerve-locating system
COMPUTER 945NCCPU NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPU
In Commercial Distribution

  • 00643169188174 ()


  • Nerve-locating system
COMPUTER, SIGNALS LAB
PENTAX OF AMERICA, INC.
7207
Not in Commercial Distribution

  • 04961333231102 ()


  • Manometric gastrointestinal motility analysis system
COMPUTER NCCPU NOTEBOOK
MEDTRONIC XOMED, INC.
NCCPU
In Commercial Distribution

  • 00613994910677 ()


  • Nerve-locating system
GL5 Notebook Computer
FHC, INC.
C0216-00675
In Commercial Distribution

  • 00873263006757 ()
C0216

  • Neurophysiologic monitoring system
  • Electroencephalograph
Tablet computer holder
Naviswiss AG
NS096
In Commercial Distribution

  • 07640176970962 ()


  • Optical surgical navigation device tracking system
Scanner computer unit
Align Technology, Inc.
211386
In Commercial Distribution

  • 00816063020844 ()


  • Dental milling system, CAD/CAM, chairside
Scanner computer unit
Align Technology, Inc.
211385
In Commercial Distribution

  • 00816063020837 ()


  • Dental milling system, CAD/CAM, chairside
ARVIS Computer Module
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-12700
In Commercial Distribution

  • 00810180350624 ()


  • Orthopaedic stereotactic surgery system
LessRay Computer Set
Nuvasive, Inc.
LRCPULOAN
In Commercial Distribution

  • 00887517790521 ()


  • Neurophysiologic monitoring system
LessRay Computer Enclosure
Nuvasive, Inc.
8230004
In Commercial Distribution

  • 00887517732699 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Computer Set
Nuvasive, Inc.
LRCPUMKT
In Commercial Distribution

  • 00887517948199 ()


  • Diagnostic x-ray digital imaging system workstation
COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000384197 ()


  • Nerve-locating system
COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000384180 ()


  • Portable computer
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