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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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Accuray Precision® Treatment Planning System - M65810550960

Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1055096
In Commercial Distribution

  • M65810550960 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Accuray Precision® Treatment Planning System - M65810502420

Software, Version 1.0, Precision Treatment Planning System The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
ACCURAY INCORPORATED
1050242
In Commercial Distribution

  • M65810502420 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Cervista HTA System - 15420045501065

No Description
Hologic, Inc.
Cervista HTA System Computer
Not in Commercial Distribution

  • 15420045501065 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Cervista Manual System - 15420045501058

No Description
Hologic, Inc.
Cervista Manual System Computer
Not in Commercial Distribution

  • 15420045501058 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

EMG Sensor - 00890477000180

No Description
SRS Medical Systems, Inc.
900-026
In Commercial Distribution

  • 00890477000180 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph

Insight Discovery EMG - 00890477000098

No Description
SRS Medical Systems, Inc.
900-037
In Commercial Distribution

  • 00890477000098 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph

VivoSight - 05060507260012

The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
MICHELSON DIAGNOSTICS LTD
VivoSight Dx
In Commercial Distribution

  • 05060507260012 ()


  • Dermatological optical coherence tomography system

VivoSight - 05060507260005

The VivoSight Topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
MICHELSON DIAGNOSTICS LTD
VivoSight
In Commercial Distribution

  • 05060507260005 ()


  • Dermatological optical coherence tomography system

REMI Robotic Navigation System - 00850026574722

REMI 8.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1385
In Commercial Distribution

  • 00850026574722 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574715

Aesculap Instrument Case
Fusion Robotics, LLC
1102
In Commercial Distribution

  • 00850026574715 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574708

REMI 7.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1375
In Commercial Distribution

  • 00850026574708 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574692

REMI 6.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1365
In Commercial Distribution

  • 00850026574692 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574685

REMI 5.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1355
In Commercial Distribution

  • 00850026574685 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574678

REMI 5.0 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1350
In Commercial Distribution

  • 00850026574678 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574661

REMI 4.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1345
In Commercial Distribution

  • 00850026574661 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574579

100mm x 6mm PSIS Pin
Fusion Robotics, LLC
6026
In Commercial Distribution

  • 00850026574579 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574555

150mm x 6mm PSIS Pin
Fusion Robotics, LLC
6025
In Commercial Distribution

  • 00850026574555 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574357

Camera Yoke
Fusion Robotics, LLC
3007
In Commercial Distribution

  • 00850026574357 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574340

Remi Robotic Navigation System
Fusion Robotics, LLC
PN-001
In Commercial Distribution

  • 00850026574340 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574333

Camera Assembly
Fusion Robotics, LLC
3005
In Commercial Distribution

  • 00850026574333 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574241

Reference Arm
Fusion Robotics, LLC
1065
In Commercial Distribution

  • 00850026574241 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574180

Instrument Tracker
Fusion Robotics, LLC
1030
In Commercial Distribution

  • 00850026574180 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574159

8mm Guide Sleeve
Fusion Robotics, LLC
1015
In Commercial Distribution

  • 00850026574159 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574142

Guide Tube with Tracker
Fusion Robotics, LLC
1010
In Commercial Distribution

  • 00850026574142 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574135

Registration Array
Fusion Robotics, LLC
1005
In Commercial Distribution

  • 00850026574135 ()


  • Robotic surgical navigation system

EXCELSIUS GPS - 00193982637354

Capped Guidewire for 1.6mm K-Wire, GPS
GLOBUS MEDICAL, INC.
6143.2703
In Commercial Distribution

  • 00193982637354 ()


  • Robotic surgical navigation system

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - 00193982625146

12mm Dilator, XLIF
GLOBUS MEDICAL, INC.
6255.7013
In Commercial Distribution

  • 00193982625146 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982623036

RELINE Small Stature Reduction Screwdriver, Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4265
In Commercial Distribution

  • 00193982623036 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982623029

RELINE Small Stature Screwdriver, Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4255
In Commercial Distribution

  • 00193982623029 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982623012

RELINE Modular Screwdriver, Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4245
In Commercial Distribution

  • 00193982623012 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622992

RELINE Modular Screwdriver Shaft, FH, GPS
GLOBUS MEDICAL, INC.
6252.4240
In Commercial Distribution

  • 00193982622992 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622985

RELINE Reduction Screwdriver Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4235
In Commercial Distribution

  • 00193982622985 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622978

RELINE MAS Guide Screwdriver Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4225
In Commercial Distribution

  • 00193982622978 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622961

RELINE MAS Reduction Screwdriver Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4215
In Commercial Distribution

  • 00193982622961 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622954

RELINE MAS Reduction Screwdriver Shaft, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4211
In Commercial Distribution

  • 00193982622954 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622930

RELINE Rigid Screwdriver Outer Sleeve, FH, GPS
GLOBUS MEDICAL, INC.
6252.4205
In Commercial Distribution

  • 00193982622930 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622923

RELINE Rigid Screwdriver Shaft, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4201
In Commercial Distribution

  • 00193982622923 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622909

RELINE Modular Screwdriver, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4141
In Commercial Distribution

  • 00193982622909 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622886

RELINE 9.5mm Awl-Tip Tap, FH, GPS
GLOBUS MEDICAL, INC.
6252.4097
In Commercial Distribution

  • 00193982622886 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622879

RELINE 9.5mm Tap, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4096
In Commercial Distribution

  • 00193982622879 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622824

RELINE 8.5mm Awl-Tip Tap, FH, GPS
GLOBUS MEDICAL, INC.
6252.4087
In Commercial Distribution

  • 00193982622824 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622817

RELINE 8.5mm Tap, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4086
In Commercial Distribution

  • 00193982622817 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622763

RELINE 7.5mm Awl-Tip Tap, FH, GPS
GLOBUS MEDICAL, INC.
6252.4077
In Commercial Distribution

  • 00193982622763 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622756

RELINE 7.5mm Tap, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4076
In Commercial Distribution

  • 00193982622756 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622732

RELINE 7.0mm Awl-Tip Tap, FH, GPS
GLOBUS MEDICAL, INC.
6252.4072
In Commercial Distribution

  • 00193982622732 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622725

RELINE 7.0mm Tap, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4071
In Commercial Distribution

  • 00193982622725 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622701

RELINE 6.5mm Awl-Tip Tap, FH, GPS
GLOBUS MEDICAL, INC.
6252.4067
In Commercial Distribution

  • 00193982622701 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622695

RELINE 6.5mm Tap, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4066
In Commercial Distribution

  • 00193982622695 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622671

RELINE 6.0mm Awl-Tip Tap, FH, GPS
GLOBUS MEDICAL, INC.
6252.4062
In Commercial Distribution

  • 00193982622671 ()


  • Robotic surgical navigation system

EXCELSIUSGPS - 00193982622664

RELINE 6.0mm Tap, Cannulated, FH, GPS
GLOBUS MEDICAL, INC.
6252.4061
In Commercial Distribution

  • 00193982622664 ()


  • Robotic surgical navigation system
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