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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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No Description
CUREXO, Inc.
CS200
In Commercial Distribution

  • 08800043830020 ()


  • Robotic surgical navigation system
No Description
CUREXO, Inc.
CS100
In Commercial Distribution

  • 08800043830013 ()
CA-00000-000

  • Robotic surgical navigation system
No Description
CUREXO, Inc.
CUVIS-spine
In Commercial Distribution

  • 08800043830006 ()
CA-00000-000

  • Robotic surgical navigation system
Genesis RMNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
Stereotaxis, Inc.
1.1
In Commercial Distribution

  • M58800101100010 ()
001-011000-1

  • Robotic surgical navigation system
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Stereotaxis, Inc.
II
In Commercial Distribution

  • M588001004115120 ()
001-004115-12

  • Robotic surgical navigation system
"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Stereotaxis, Inc.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Stereotaxis, Inc.
II
In Commercial Distribution

  • M588001004115110 ()
001-004115-11

  • Robotic surgical navigation system
VELYS™ Robotic-Assist Station
Medos International Sàrl
451611001
In Commercial Distribution

  • 10705034646008 ()
451611001

  • Robotic surgical navigation system
VELYS™ TOOL HOLDER L
Medos International Sàrl
451611032
In Commercial Distribution

  • 10705034643472 ()
451611032

  • Robotic surgical navigation system
VELYS™ Camera Station
Medos International Sàrl
451611002
In Commercial Distribution

  • 10705034646015 ()
451611002

  • Robotic surgical navigation system
VELYS™ Navigation Station
Medos International Sàrl
451611000
In Commercial Distribution

  • 10705034645995 ()
451611000

  • Robotic surgical navigation system
VELYS™ TOOL HOLDER S
Medos International Sàrl
451611030
In Commercial Distribution

  • 10705034643496 ()
451611030

  • Robotic surgical navigation system
VELYS™ TOOL HOLDER M
Medos International Sàrl
451611031
In Commercial Distribution

  • 10705034643489 ()
451611031

  • Robotic surgical navigation system
VELYS SPINE DRAPE CAP
Medos International Sàrl
451611063
In Commercial Distribution

  • 10705034643335 ()
451611063

  • Robotic surgical navigation system
SI-LOK Tap, 10.0mm, GPS
GLOBUS MEDICAL, INC.
6143.2856
In Commercial Distribution

  • 00889095375640 ()


  • Robotic surgical navigation system
SI-LOK Tap, 8.0mm, GPS
GLOBUS MEDICAL, INC.
6143.2855
In Commercial Distribution

  • 00889095375633 ()


  • Robotic surgical navigation system
SI-LOK Drill, 10.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2854
In Commercial Distribution

  • 00889095375626 ()


  • Robotic surgical navigation system
SI-LOK Drill, 9.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2853
In Commercial Distribution

  • 00889095375619 ()


  • Robotic surgical navigation system
SI-LOK Drill, 8.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2852
In Commercial Distribution

  • 00889095375602 ()


  • Robotic surgical navigation system
SI-LOK Drill, 6.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2850
In Commercial Distribution

  • 00889095375589 ()


  • Robotic surgical navigation system
T27 Cannulated Shaft, SI-LOK Select Driver, GI1
GLOBUS MEDICAL, INC.
6202.6652
In Commercial Distribution

  • 00889095965582 ()


  • Robotic surgical navigation system
Outer Sleeve, SI-LOK Select Driver, GI1
GLOBUS MEDICAL, INC.
6202.6650
In Commercial Distribution

  • 00889095965568 ()


  • Robotic surgical navigation system
T27 Non-Cannulated Shaft, SI-LOK Select Driver, GPS
GLOBUS MEDICAL, INC.
6202.2831
In Commercial Distribution

  • 00889095965544 ()


  • Robotic surgical navigation system
T27 Non-Cannulated Shaft, SI-LOK Select Driver, GI1
GLOBUS MEDICAL, INC.
6202.6651
In Commercial Distribution

  • 00889095965575 ()


  • Robotic surgical navigation system
T27 Cannulated Shaft, SI-LOK Select Driver, GPS
GLOBUS MEDICAL, INC.
6202.2832
In Commercial Distribution

  • 00889095965551 ()


  • Robotic surgical navigation system
Outer Sleeve, SI-LOK Select Driver, GPS
GLOBUS MEDICAL, INC.
6202.2830
In Commercial Distribution

  • 00889095965537 ()


  • Robotic surgical navigation system
System, EXCELSIUS GPS, 120V
GLOBUS MEDICAL, INC.
6143.1001
In Commercial Distribution

  • 00889095481297 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Outer Sleeve, GI1
GLOBUS MEDICAL, INC.
6200.1405
In Commercial Distribution

  • 00889095782486 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Shaft, GI1
GLOBUS MEDICAL, INC.
6200.1400
In Commercial Distribution

  • 00889095782479 ()


  • Robotic surgical navigation system
CREO NXT Rigid Screwdriver Outer Sleeve, GPS
GLOBUS MEDICAL, INC.
6200.1095
In Commercial Distribution

  • 00889095782462 ()


  • Robotic surgical navigation system
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