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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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vMap Disposables - 00860007954108

No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • 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

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

Volta AF-Xplorer - 03770019196038

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution

  • 03770019196038 ()
A002

  • Cardiac mapping system computer

VX1 - 03770019196007

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution

  • 03770019196007 ()
A001

  • 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
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