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 Class Implantable

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AcQMap® Ablation Interface Unit Cable
ACUTUS MEDICAL, INC.
800112
Not in Commercial Distribution

  • 00857042007104 ()
800112

  • Cardiac mapping system
AcQMap® Patient Interface Unit Cable
ACUTUS MEDICAL, INC.
800113
Not in Commercial Distribution

  • 00857042007098 ()
800113

  • Cardiac mapping system
AcQMap® Patient Interface Unit
ACUTUS MEDICAL, INC.
800229
Not in Commercial Distribution

  • 00857042007081 ()
800229

  • Cardiac mapping system
Ampere® Adapter Cable AcQMap® Ablation Catheter
ACUTUS MEDICAL, INC.
800430
Not in Commercial Distribution

  • 00857042007074 ()
800430

  • Cardiac mapping system
AcQMap® Ablation Interface Unit
ACUTUS MEDICAL, INC.
800244-001
Not in Commercial Distribution

  • 00857042007067 ()
800244-001

  • Cardiac mapping system
AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system
AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution

  • 00857042007043 ()
800258

  • Cardiac mapping system
North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system
AcQMap to DiamondTemp Generator Adapter Cable
ACUTUS MEDICAL, INC.
800818
Not in Commercial Distribution

  • 00850027837635 ()
800818

  • Cardiac mapping system
AcQMap to DiamondTemp Generator Adapter
ACUTUS MEDICAL, INC.
800727
Not in Commercial Distribution

  • 00850027837253 ()
800727

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system
X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-2.0.1
In Commercial Distribution

  • 05415067046710 ()
ENSITE-DWS-2.0.1

  • Cardiac mapping system
X EP System EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-2.0.1
In Commercial Distribution

  • 05415067046680 ()
ENSITE-R-DWS-2.0.1

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-1.1
In Commercial Distribution

  • 05415067037725 ()
ENSITE-DWS-1.1

  • Cardiac mapping system
RhythmView Workstation, US, streaming, refurbished
ABBOTT
2002-R
Not in Commercial Distribution

  • 00810591020185 ()
2002-R

  • Cardiac mapping system
RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system
USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system
RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system
RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system
Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

  • Cardiac mapping system
SWR KIT CARDIOSOFT V6.73
Carefusion Corporation
28282-001
Not in Commercial Distribution

  • 10846446032918 ()
28282-001

  • Cardiac mapping system
SWR PKG CARDIOSOFT V6.73
Carefusion Corporation
28281-001
Not in Commercial Distribution

  • 10846446032901 ()
28281-001

  • Cardiac mapping system
CARDIOSOFT V6.73 CAM14 W/USB
Carefusion Corporation
28278-001
Not in Commercial Distribution

  • 10846446032888 ()
28278-001

  • Cardiac mapping system
CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system
NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution

  • 10846835011678 ()
FG170000

  • Cardiac mapping system
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system
Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system
Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system
Rhythmia Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40000
In Commercial Distribution

  • 08714729842118 ()


  • Cardiac mapping system
ECG Box Out - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RH14000
In Commercial Distribution

  • 08714729842033 ()


  • Cardiac mapping system
Breakout Box MAP Out
BOSTON SCIENTIFIC CORPORATION
M004RH13000
In Commercial Distribution

  • 08714729842026 ()


  • Cardiac mapping system
Breakout Box B Out
BOSTON SCIENTIFIC CORPORATION
M004RH12500
In Commercial Distribution

  • 08714729842019 ()


  • Cardiac mapping system
Breakout Box B In
BOSTON SCIENTIFIC CORPORATION
M004RH12000
In Commercial Distribution

  • 08714729842002 ()


  • Cardiac mapping system
Breakout Box A Out
BOSTON SCIENTIFIC CORPORATION
M004RH11500
In Commercial Distribution

  • 08714729841999 ()


  • Cardiac mapping system
Breakout Box A In
BOSTON SCIENTIFIC CORPORATION
M004RH11000
In Commercial Distribution

  • 08714729841982 ()


  • Cardiac mapping system
Conditioning Box
BOSTON SCIENTIFIC CORPORATION
M004RACONDITION0
In Commercial Distribution

  • 08714729841838 ()


  • Cardiac mapping system
Connection Box - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62000
In Commercial Distribution

  • 08714729841760 ()


  • Cardiac mapping system
Connection Box - IBI™
BOSTON SCIENTIFIC CORPORATION
M004RA61000
In Commercial Distribution

  • 08714729841753 ()


  • Cardiac mapping system
Connection Box - Stockert™
BOSTON SCIENTIFIC CORPORATION
M004RA60000
In Commercial Distribution

  • 08714729841746 ()


  • Cardiac mapping system
Inca PV loop system for the measurement of cardiac function and performance.
CD Leycom
CFL-M Inca
In Commercial Distribution

  • 08717953256645 ()
CDL001

  • Cardiac mapping system
No Description
VISIOMED GROUP
BW-HR1
In Commercial Distribution

  • 03760165449270 ()


  • Cardiac mapping system
Ablation Connection Box (Maestro™)
BOSTON SCIENTIFIC CORPORATION
M004RA6201US0
In Commercial Distribution

  • 08714729966326 ()


  • Cardiac mapping system
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