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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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EndoPAT2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225364 ()
  • 07290109225371 ()
AS1650030

  • Cardiovascular-risk peripheral arterial tonometry system
Endo PAT 2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225357 ()
  • 07290109225333 ()
  • 07290109225319 ()
US1650004

  • Cardiovascular-risk peripheral arterial tonometry system
EndoPAT2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225340 ()
  • 07290109225326 ()
  • 07290109225302 ()
AS1650004

  • Cardiovascular-risk peripheral arterial tonometry system
Accessories for EndoPATx
ITAMAR MEDICAL LTD
Accessories, EndoPATx
In Commercial Distribution

  • 07290109225227 ()
AC0001650

  • Cardiovascular-risk peripheral arterial tonometry system
Anchors(30), EndoPAT
ITAMAR MEDICAL LTD
Anchors(30) for Endo PAT 2000
In Commercial Distribution

  • 07290109225210 ()
AC0572070

  • Cardiovascular-risk peripheral arterial tonometry system
Accessories, EndoPAT2000
ITAMAR MEDICAL LTD
Accessories for Endo PAT 2000
In Commercial Distribution

  • 07290109225203 ()
AC0001600

  • Cardiovascular-risk peripheral arterial tonometry system
12 Pneumatic Endo probes
ITAMAR MEDICAL LTD
12 Pneumatic Endo probes for Endo PAT 2000
In Commercial Distribution

  • 07290109225005 ()
AC1600005

  • Cardiovascular-risk peripheral arterial tonometry system sensor
Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
64 Ch. Console System
In Commercial Distribution

  • 07290102933082 ()
965-100-046

  • Cardiac electrophysiology analysis system
Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
64 Ch. Lite System
In Commercial Distribution

  • 07290102932832 ()
965-100-145

  • Cardiac electrophysiology analysis system
Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
64 Ch. Mobile System
In Commercial Distribution

  • 07290102933075 ()
965-100-036

  • Cardiac electrophysiology analysis system
Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
32 Ch. Console System
In Commercial Distribution

  • 07290102933068 ()
965-100-036

  • Cardiac electrophysiology analysis system
Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
32 Ch. Mobile System
In Commercial Distribution

  • 07290102933051 ()
965-100-035

  • Cardiac electrophysiology analysis system
Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
32 Ch. Lite System
In Commercial Distribution

  • 07290102932818 ()
965-100-135

  • Cardiac electrophysiology analysis system
Premier Heart MCG 12 Lead capture hardware.
PREMIER HEART, LLC
VH12
In Commercial Distribution

  • B320VH120 ()


  • Electrocardiograph, professional, multichannel
MCG Analysis API (Dedicated Server or Software-as-a-Service)
PREMIER HEART, LLC
MCGS
In Commercial Distribution

  • B320MCGS0 ()


  • Cardiopulmonary physiological parameter analysis software
Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
PREMIER HEART, LLC
MCGC
In Commercial Distribution

  • B320MCGC0 ()


  • Cardiopulmonary physiological parameter analysis software
Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel
Magnetic Tracking System Kit
BOSTON SCIENTIFIC CORPORATION
M004RBLMR100
In Commercial Distribution

  • 08714729880318 ()


  • Electromagnetic surgical navigation device tracking system
No Description
BOSTON SCIENTIFIC CORPORATION
H7495554280
In Commercial Distribution

  • 08714729986089 ()
H7495554280

  • Cardiovascular ultrasound imaging system
Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system
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