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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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Innocor Cardio-pulmonary function test equipment
Innovision ApS
INN00100-1
In Commercial Distribution

  • 05713867000124 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00100
In Commercial Distribution

  • 05713867000025 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00300
In Commercial Distribution

  • 05713867000018 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
No Description
Vektor Medical, Inc.
VMDISP2
In Commercial Distribution

  • 00860007954115 ()


  • Cardiac mapping system workstation
HEARTCENTRIX v7.1.0 FIXPACK INSTAL KIT
WELCH ALLYN, INC.
901152
In Commercial Distribution

  • 00732094335866 ()
H50-71A

  • Patient health record information system application software
HSCRIBE TO PYRAMIS INTERFACE
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094315318 ()
11095-002-70

  • Patient health record information system application software
SFTW PYRAMIS IE9 10 UPGRADE V6.2 6.5
WELCH ALLYN, INC.
901152
In Commercial Distribution

  • 00732094272338 ()
11094-001-50

  • Patient health record information system application software
UPGRADE KIT FOR HEARTCENTRIX
WELCH ALLYN, INC.
901152
In Commercial Distribution

  • 00732094261332 ()
UPGHC-B-SW-A

  • Patient health record information system application software
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Cathvision ApS
CVT-0069 R3.2
In Commercial Distribution

  • 05745001034009 ()
CVT-0069 R3.2 ECGenius System

  • Cardiac electrophysiology analysis system
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
In Commercial Distribution

STAR Apollo Mapping System

  • Cardiac mapping system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution

  • 00860009793507 ()
STAR Apollo Mapping System

  • Cardiac mapping system application software
Cable
ST. JUDE MEDICAL, INC.
H21922
In Commercial Distribution

  • 05414734219228 ()
H21922

  • Electrical-only medical device connection cable, reusable
Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Recording System
In Commercial Distribution

  • 05414734219105 ()
H21910

  • Cardiac catheterization monitoring system
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214841 ()
75-06066-001

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214636 ()
75-05772-001

  • Cardiac mapping system application software
Ablation Cable Kit, IBI,T9
ST. JUDE MEDICAL, INC.
75-05392-001
In Commercial Distribution

  • 05414734214469 ()
75-05392-001

  • Electrical-only medical device connection cable, reusable
Recorder Interconnect Kit, EPMED V5.0
ST. JUDE MEDICAL, INC.
75-04630-002
In Commercial Distribution

  • 05414734213738 ()
75-04630-002

  • Electrical-only medical device connection cable, reusable
Ablation Cable Kit,Stockert
ST. JUDE MEDICAL, INC.
75-04469-003
In Commercial Distribution

  • 05414734213684 ()
75-04469-003

  • Electrical-only medical device connection cable, reusable
Ablation Cable Kit, EPT
ST. JUDE MEDICAL, INC.
75-04467-004
In Commercial Distribution

  • 05414734213660 ()
75-04467-004

  • Electrical-only medical device connection cable, reusable
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