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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CABLE 05409 ATAKR COMPUTER
MEDTRONIC, INC.
05409
In Commercial Distribution

  • 00643169135598 ()

  • Length: 10.0 Feet
  • Length: 305.0 Centimeter


  • Electrical-only medical device connection cable, reusable
COMPUTER NCCPU NOTEBOOK ROHS
MEDTRONIC XOMED, INC.
NCCPU
In Commercial Distribution

  • 00643169177710 ()


  • Nerve-locating system
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPULO
In Commercial Distribution

  • 00643169020191 ()


  • Nerve-locating system
COMPUTER 945NCCPUE4LO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPUE4LO
In Commercial Distribution

  • 00643169553088 ()


  • Nerve-locating system
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPULO
In Commercial Distribution

  • 00643169553071 ()


  • Nerve-locating system
COMPUTER 945NCCPUE4LO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPUE4LO
In Commercial Distribution

  • 00643169793873 ()


  • Nerve-locating system
COMPUTER 9734519R BRIDGESTONE REWORK
MEDTRONIC NAVIGATION, INC.
9734519R
In Commercial Distribution

  • 00613994763464 ()


  • Multi-purpose stereotactic surgery system
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPULO
In Commercial Distribution

  • 00643169861459 ()


  • Nerve-locating system
CABLE 05409 ATAKR COMPUTER
MEDTRONIC, INC.
05409
In Commercial Distribution

  • 00681490024358 ()

  • Length: 10.0 Feet


  • Electrical-only medical device connection cable, reusable
Computer ComboLab Acquisition v7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682146029 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Computer CardioLab Acquisition v7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682146012 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
Computer Mac-Lab Acquisition v7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145985 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
SEEKER™ Personal Computer
BAEBIES, INC.
3428
In Commercial Distribution

  • 00819704020258 ()
3428

  • Multichannel clinical chemistry analyser IVD, laboratory
SEEKER™ Personal Computer
BAEBIES, INC.
3145
Not in Commercial Distribution

  • 00819704020241 ()
3145

  • Multichannel clinical chemistry analyser IVD, laboratory
SEEKER™ Personal Computer
BAEBIES, INC.
3132
Not in Commercial Distribution

  • 00819704020234 ()
3132

  • Multichannel clinical chemistry analyser IVD, laboratory
COMPUTER DIGITAL VIDEO SYSTEM
PENTAX OF AMERICA, INC.
7245D
In Commercial Distribution

  • 04961333242054 ()


  • Video cassette recorder
COMPUTER DIGITAL VIDEO SYSTEM
PENTAX OF AMERICA, INC.
7245C
Not in Commercial Distribution

  • 04961333231638 ()


  • Manometric gastrointestinal motility analysis system
AltiX AI.i ComboLab Computer
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278935687 ()
2400000-005

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
AltiX AI.i CardioLab Computer
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278935656 ()
2400000-004

  • Cardiac electrophysiology analysis system
Computer ComboLab Acquisition v8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278507051 ()
2300000-005

  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Computer CardioLab Acquisition v8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278507044 ()
2300000-004

  • Cardiac electrophysiology analysis system
AltiX AI.i Mac-Lab Computer
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278935632 ()
2400000-003

  • Cardiac catheterization monitoring system
5 leg computer stand
PRYOR PRODUCTS
500
In Commercial Distribution

  • 00761887001497 ()
500

  • Freestanding/bed-attached intravenous pole
5 leg Computer Cart
PRYOR PRODUCTS
520
In Commercial Distribution

  • 00761887000407 ()
520

  • Freestanding/bed-attached intravenous pole
SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350201490 ()
502-0149

  • Electroencephalograph
Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350101320 ()
502-0132

  • Electroencephalograph
COMPUTER NWCPU DESKTOP ENGLISH ROHS
MEDTRONIC XOMED, INC.
NWCPU
In Commercial Distribution

  • 00643169221000 ()


  • Nerve-locating system
COMPUTER 9735602 FUSION COMP LOADED
MEDTRONIC NAVIGATION, INC.
9735602
In Commercial Distribution

  • 00643169672956 ()


  • ENT stereotactic surgery system
COMPUTER 9735704R FUSION COMPACT RFRB
MEDTRONIC NAVIGATION, INC.
9735704R
Not in Commercial Distribution

  • 00643169791862 ()


  • Multi-purpose stereotactic surgery system
COMPUTER 9735225R ROLLINGSTONE S7 RFRB
MEDTRONIC NAVIGATION, INC.
9735225R
In Commercial Distribution

  • 00643169291539 ()


  • Multi-purpose stereotactic surgery system
COMPUTER 9734860R ROLLINGSTONE FSN RFRB
MEDTRONIC NAVIGATION, INC.
9734860R
In Commercial Distribution

  • 00643169291515 ()


  • Multi-purpose stereotactic surgery system
COMPUTER NCCPU NOTEBOOK E6540 ROHS
MEDTRONIC XOMED, INC.
NCCPU
In Commercial Distribution

  • 00643169468573 ()


  • Nerve-locating system
Computer Power Cord, 3.0 ft
ALPHATEC SPINE, INC.
525-412-011
In Commercial Distribution

  • 00190376635606 ()


  • Neurological stereotactic surgery system
Power Supply for Tablet Computer
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
NM-6317
In Commercial Distribution

  • 08714729935179 ()


  • Analgesic spinal cord electrical stimulation system
OSP Workstation, 166 MHz (computer)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936396
In Commercial Distribution

  • 10758750005451 ()
936396

  • Enzyme immunoassay (EIA) analyser IVD
Computer Holder for Tower Enclosure
Touchpoint Medical, Inc.
TS.6146.991
In Commercial Distribution

  • 00840178702340 ()


  • Medical monitor/light mount
COMPUTER DIGITAL VIDEO SY 230V
PENTAX OF AMERICA, INC.
7245C/E
Not in Commercial Distribution

  • 04961333231645 ()


  • Manometric gastrointestinal motility analysis system
Computer for Mult-Speech or CSL
PENTAX OF AMERICA, INC.
4307
In Commercial Distribution

  • 04961333230037 ()


  • Electroglottograph
DESKTOP COMPUTER/ENDEAVOR CR - Demo
NATUS NEUROLOGY INCORPORATED
DM-842-128400
In Commercial Distribution

  • 00382830032001 ()


  • Electromyograph
NOTEBOOK COMPUTER/ENDEAVOR CR - Demo
NATUS NEUROLOGY INCORPORATED
DM-842-128500
In Commercial Distribution

  • 00382830031998 ()


  • Electromyograph
LessRay Image Enhancement Sys Computer
Nuvasive, Inc.
8230045
In Commercial Distribution

  • 00887517994820 ()


  • Diagnostic x-ray digital imaging system workstation
COMPUTER 9736242 AIO FLEX ENT
MEDTRONIC NAVIGATION, INC.
9736242
In Commercial Distribution

  • 00763000336592 ()


  • Multi-purpose stereotactic surgery system
fastmill.io system (fastdesign.io computer + fastmill.io)
Prismatik Dentalcraft, Inc
70-1181-MIL0016
In Commercial Distribution

  • D745701181MIL00160 ()
70-1181-MIL0016

  • CAD/CAM software
Computer stand with Gear base
PRYOR PRODUCTS
500G
In Commercial Distribution

  • 00761887005099 ()
500G

  • Freestanding/bed-attached intravenous pole
Leica Biosystems Adaptec 8405E Raid Controller
Leica Biosystems Richmond, Inc.
23BDI0036
Not in Commercial Distribution

  • 00849832013297 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD with Image, Dell T7500 RAID 1, Win 7
Leica Biosystems Richmond, Inc.
23DKI7517
Not in Commercial Distribution

  • 00849832009894 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5817
Not in Commercial Distribution

  • 00849832009887 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5810
Not in Commercial Distribution

  • 00849832009870 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5807
Not in Commercial Distribution

  • 00849832009863 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5800
Not in Commercial Distribution

  • 00849832009856 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
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