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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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FilmArray® 2.0 Instrument NGDS Configuration - 00851458005143

NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BD FocalPoint™ GS Review Station - 00382904901899

BD FocalPoint™ GS Review Station Computer
BECTON, DICKINSON AND COMPANY
490189
In Commercial Distribution

  • 00382904901899 ()

  • Height: 33.2 Centimeter
  • Width: 55 Centimeter
  • Length: 59.2 Centimeter
490189

  • Cell morphology analyser IVD, manual

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116040

CompuFlo Epidural Computer Controlled Anesthesia System 220V
Milestone Scientific Inc.
EPI-6000-220
In Commercial Distribution

  • 00618874116040 ()


  • Electronic epidural space locator control unit

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116033

CompuFlo Epidural Computer Controlled Anesthesia System 110V
Milestone Scientific Inc.
EPI-6000-110
In Commercial Distribution

  • 00618874116033 ()


  • Electronic epidural space locator control unit

MammoScreen - B885MAML2US0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software

MammoScreen - B885MAML0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software

Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

Vita LE CR System - 60889971067708

NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner

Vita XE CR System - 60889971067685

NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner

vMap Control Unit - 00860007954177

No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution

  • 00860007954177 ()


  • Cardiac mapping system computer

vMap Disposables - 00860007954108

No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer

QUANTIEN™ - 05415067023704

No Description
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067023704 ()
H702370

  • Cardiac catheterization laboratory computer

Ablamap® System - 00860457001568

The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
Ablacon Inc.
AB-0007
In Commercial Distribution

  • 00860457001568 ()


  • Cardiac mapping system computer

Navik 3D - 00869781000308

Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.
APN HEALTH
Navik 3D v2.0
In Commercial Distribution

  • 00869781000308 ()
200-00668

  • Cardiac mapping system computer

Merge Hemo Link Assembly - 00842000100515

Merge Hemo 77-00327-00 Link Assembly
MERGE HEALTHCARE SOLUTIONS INC.
77-00327-00
In Commercial Distribution

  • 00842000100515 ()


  • Cardiac catheterization laboratory computer

Merge HEMO - 00842000100034

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.1
In Commercial Distribution

  • 00842000100034 ()


  • Cardiac catheterization laboratory computer

Merge Hemo - 00842000100010

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.0.4
In Commercial Distribution

  • 00842000100010 ()


  • Cardiac catheterization laboratory computer

FUJIFILM - 04547410389005

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard

FUJIFILM - 04547410388992

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard

PENTAX Medical - 04961333251650

PENTAX Medical Keyboard EN OS-A116
HOYA CORPORATION
OS-A116
In Commercial Distribution

  • 04961333251650 ()


  • Computer/medical device keyboard

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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