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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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System 4 MVP - 00718175004401

System 4 MVP
BIODEX MEDICAL SYSTEMS, INC.
852-000
In Commercial Distribution

  • 00718175004401 ()
852-000

  • Biomechanical function analysis system, force-testing, stationary

System 4 Quick Set - 00718175004203

System 4 Quick Set
BIODEX MEDICAL SYSTEMS, INC.
840-000
In Commercial Distribution

  • 00718175004203 ()
840-000

  • Biomechanical function analysis system, force-testing, stationary

MJS System 3 Upgrade - 00718175004067

Biodex Multi-Joint-System 3 Rev.1 UpGrade
BIODEX MEDICAL SYSTEMS, INC.
850-822
Not in Commercial Distribution

  • 00718175004067 ()
850-822

  • Biomechanical function analysis system, force-testing, stationary

System 4 Pro - 00718175004005

Biodex System 4 Pro
BIODEX MEDICAL SYSTEMS, INC.
850-000
In Commercial Distribution

  • 00718175004005 ()
850-000

  • Biomechanical function analysis system, force-testing, stationary

n.a. - 04048551325971

Navigation-Panel
Karl Storz GmbH & Co. KG
40800021
In Commercial Distribution

  • 04048551325971 ()


  • Optical surgical navigation device tracking system workstation, mobile

Prism - 10850390007380

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
Prism1
In Commercial Distribution

  • 10850390007380 ()


  • Biomechanical function analysis system, force-testing, stationary

Provider Test Kit (PTK) - 10850390007359

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
1
In Commercial Distribution

  • 10850390007359 ()


  • Biomechanical function analysis system, force-testing, stationary

EvalTech - 10850390007328

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
EvalTech
In Commercial Distribution

  • 10850390007328 ()


  • Biomechanical function analysis system, force-testing, stationary

ER - 10850390007311

No Description
BTE TECHNOLOGIES, INC.
ER
Not in Commercial Distribution

  • 10850390007311 ()


  • Biomechanical function analysis system, force-testing, stationary

PrimusRS - 10850390007243

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
PrimusRS
In Commercial Distribution

  • 10850390007243 ()


  • Biomechanical function analysis system, force-testing, stationary

Primus - 10850390007236

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Primus+
Not in Commercial Distribution

  • 10850390007236 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007151

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 5
In Commercial Distribution

  • 10850390007151 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007137

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 03
In Commercial Distribution

  • 10850390007137 ()


  • Biomechanical function analysis system, force-testing, stationary

Op.n Core - 03701311501435

No Description
ECENTIAL ROBOTICS
I01014
In Commercial Distribution

  • 03701311501435 ()


  • Optical surgical navigation device tracking system workstation, mobile

REAL INTELLIGENCE - 00885556774151

REAL INTELLIGENCE ROBOTICS CART BASE 220
Smith & Nephew, Inc.
ROB100022
In Commercial Distribution

  • 00885556774151 ()
ROB100022

  • Optical surgical navigation device tracking system workstation, mobile

REAL INTELLIGENCE - 00885556774144

REAL INTELLIGENCE ROBOTICS CART BASE 120
Smith & Nephew, Inc.
ROB100021
In Commercial Distribution

  • 00885556774144 ()
ROB100021

  • Optical surgical navigation device tracking system workstation, mobile

REAL INTELLIGENCE - 00885556756249

REAL INTELLIGENCE ROBOTICS CART COLUMN
Smith & Nephew, Inc.
ROB10002
In Commercial Distribution

  • 00885556756249 ()
ROB10002

  • Optical surgical navigation device tracking system workstation, mobile

Accuray Precision® Treatment Planning System - M65810642700

Software, Version 2.0, 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
1064270
In Commercial Distribution

  • M65810642700 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system

Accuray Precision® Treatment Planning System - M65810617990

Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1) 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
1061799
In Commercial Distribution

  • M65810617990 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Accuray Precision® Treatment Planning System - M65810598110

Software, Version 1.1.1, 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
1059811
In Commercial Distribution

  • M65810598110 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system

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

NA - 04546540401632

VECTOR CALIBRATION DEVICE
Stryker Leibinger GmbH & Co. KG
6000-008-000
In Commercial Distribution

  • 04546540401632 ()
6000-008-000

  • Robotic surgical navigation system

NA - 04546540245090

POINT CALIBRATION DEVICE (PCD)
Stryker Leibinger GmbH & Co. KG
6000-010-000
In Commercial Distribution

  • 04546540245090 ()
6000-010-000

  • Robotic surgical navigation system

Surgical Base System - 04260583190017

No Description
Brainlab AG
20100131
Not in Commercial Distribution

  • 04260583190017 ()


  • Robotic surgical navigation system

N/A - 00850030914026

Robotic Arm & Accessories
Microport Navibot International LLC
10008NBSUB
In Commercial Distribution

  • 00850030914026 ()
10008NBSUB

  • Robotic surgical navigation system
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