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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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PENTAX Medical - 04961333247462

PENTAX Medical Keyboard EN OS-A115
HOYA CORPORATION
OS-A115
In Commercial Distribution

  • 04961333247462 ()


  • Computer/medical device keyboard

PENTAX Medical - 04961333233557

PENTAX Medical Keyboard EN OS-A111
HOYA CORPORATION
OS-A111
In Commercial Distribution

  • 04961333233557 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170343384

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1995
In Commercial Distribution

  • 04953170343384 ()
N4505930

  • Computer/medical device keyboard

KEYBOARD - 04953170356797

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1995
In Commercial Distribution

  • 04953170356797 ()
N4505940

  • Computer/medical device keyboard

KEYBOARD - 04953170356087

MAJ-1710 EU-ME1 Keyboard
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1710
Not in Commercial Distribution

  • 04953170356087 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170338540

MAJ-1981 KEYBOARD FOR CV-170
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1981
In Commercial Distribution

  • 04953170338540 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170304927

MAJ-1921 VISERA ELITE KEYBOARD
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1921
In Commercial Distribution

  • 04953170304927 ()
N3646630

  • Computer/medical device keyboard

KEYBOARD - 04953170264955

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1710
Not in Commercial Distribution

  • 04953170264955 ()


  • Computer/medical device keyboard

KEY BOARD - 04953170026324

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-844
In Commercial Distribution

  • 04953170026324 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170222542

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1463
In Commercial Distribution

  • 04953170222542 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170214493

MAJ-1428 KEYBOARD EVIS EXERA II
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1428
In Commercial Distribution

  • 04953170214493 ()


  • Computer/medical device keyboard

VISERA VIDEO SYSTEM CENTER - 04953170142055

MAJ-1124 VISERA SYSTEM KEYBOARD
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1124
In Commercial Distribution

  • 04953170142055 ()


  • Computer/medical device keyboard

Sensis Vibe Combo - 04056869010205

Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007642
In Commercial Distribution

  • 04056869010205 ()


  • Cardiac catheterization laboratory computer

Sensis Vibe Hemo - 04056869010199

Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007641
In Commercial Distribution

  • 04056869010199 ()


  • Cardiac catheterization laboratory computer

Sensis Lite - 04056869010144

No Description
Siemens Healthcare GmbH
10764562
In Commercial Distribution

  • 04056869010144 ()


  • Cardiac catheterization laboratory computer

Sensis - 04056869010137

No Description
Siemens Healthcare GmbH
10764561
In Commercial Distribution

  • 04056869010137 ()


  • Cardiac catheterization laboratory computer

BR Surgical, LLC - 00840183528614

Keyboard for Image Capture System
BR Surgical, LLC
BR900-1306
In Commercial Distribution

  • 00840183528614 ()
BR900-1306

  • Computer/medical device keyboard

ACIST RXi® Console with dPR - 10841716103763

RXi Console with dPR, US (p/n: 800939-010 )
ACIST MEDICAL SYSTEMS, INC.
019994
In Commercial Distribution

  • 10841716103763 ()
  • 30841716103767 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Navvus Interface - 10841716101790

RXi Mini Navvus Interface p/n 701600-002
ACIST MEDICAL SYSTEMS, INC.
018592
In Commercial Distribution

  • 30841716101794 ()
  • 10841716101790 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Processing Unit - 10841716101783

RXi Mini Processing Unit p/n 701630-002
ACIST MEDICAL SYSTEMS, INC.
018593
In Commercial Distribution

  • 30841716101787 ()
  • 10841716101783 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Mount - 10841716101769

RXi Mini Mounts p/n 701601-008
ACIST MEDICAL SYSTEMS, INC.
018594
In Commercial Distribution

  • 30841716101763 ()
  • 10841716101769 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System - 10841716101738

RXi System Console, p/n 701640-001
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 30841716101732 ()
  • 10841716101738 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Ao Interface Box - 10841716101448

Ao Interface Box, p/n 701587-001 Contents: Ao interface box, mounting bracket, cables
ACIST MEDICAL SYSTEMS, INC.
018311
In Commercial Distribution

  • 30841716101442 ()
  • 10841716101448 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System - 10841716101257

RXi System Console, p/n 701309-008
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 30841716100384 ()
  • 10841716101257 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Cart - 10841716100595

RXi Cart, p/n 701606-001
ACIST MEDICAL SYSTEMS, INC.
018111
In Commercial Distribution

  • 30841716100599 ()
  • 10841716100595 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Bed Rail Mount - 10841716100588

RXi Bed Rail Mount, p/n 701605-001
ACIST MEDICAL SYSTEMS, INC.
017753
In Commercial Distribution

  • 10841716100588 ()
  • 30841716100582 ()


  • Cardiac catheterization laboratory computer

VISITAG EXT PROCESSING UNIT ACCESS - 10846835018585

DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution

  • 10846835018585 ()
M665701SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU SPARE - 10846835018578

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution

  • 10846835018578 ()
M660201SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU - 10846835018554

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution

  • 10846835018554 ()
M660202SP

  • Cardiac mapping system computer

VISITAG SURPOINT External Processing Unit - 10846835017885

External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer
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