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

  • 04953170304927 ()
N3646630

  • Computer/medical device keyboard
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1710
Not in Commercial Distribution

  • 04953170264955 ()


  • Computer/medical device keyboard
MAJ-1981 KEYBOARD FOR CV-170
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1981
In Commercial Distribution

  • 04953170338540 ()


  • Computer/medical device keyboard
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1463
In Commercial Distribution

  • 04953170222542 ()


  • Computer/medical device keyboard
MAJ-1428 KEYBOARD EVIS EXERA II
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1428
In Commercial Distribution

  • 04953170214493 ()


  • Computer/medical device keyboard
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™ 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
No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution

  • 00860007954177 ()


  • Cardiac mapping system computer
No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer
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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