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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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DR-ID 670MC - 04547410261189

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 670 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410261189 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410235937

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 601 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410235937 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410134551

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 600 MC E
In Commercial Distribution

  • 04547410134551 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410556452

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W MDR E
In Commercial Distribution

  • 04547410556452 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410556438

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC MDR E
In Commercial Distribution

  • 04547410556438 ()


  • Stationary basic diagnostic x-ray system, digital

CathCheck Disposable Kit (Pre-assembled) - 00618874601034

CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6010-03
In Commercial Distribution

  • 00618874601034 ()


  • Epidural anaesthesia set, non-medicated

BRAEBON USB Cable for MediByte - B14189000

USB Cable for connecting the MediByte to the computer for configuration and data download.
Braebon Medical Corporation
8900
In Commercial Distribution

  • B14189000 ()
8900

  • Electrical-only medical device connection cable, reusable

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

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

ENVISION 3D: LIGHT HANDLE - 00627843746669

No Description
7D Surgical ULC
11-0005
In Commercial Distribution

  • 00627843746669 ()


  • Optical surgical navigation device tracking system workstation, mobile

ENVISION 3D: IMAGE GUIDANCE SYSTEM - 00627843746614

No Description
7D Surgical ULC
10-0001
In Commercial Distribution

  • 00627843746614 ()


  • Optical surgical navigation device tracking system workstation, mobile

7D Surgical System - 00628341520379

No Description
7D Surgical ULC
10-0001
In Commercial Distribution

  • 00628341520379 ()


  • Optical surgical navigation device tracking system workstation, mobile

n.a. - 04048551325971

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

  • 04048551325971 ()


  • Optical surgical navigation device tracking system workstation, mobile

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

ER - 10850390007311

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

  • 10850390007311 ()


  • 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

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

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

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 - 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 - 00885556756249

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

  • 00885556756249 ()
ROB10002

  • 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

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

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

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

N/A - 00850030914026

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

  • 00850030914026 ()
10008NBSUB

  • Robotic surgical navigation system

N/A - 00850030914019

Surgical Console
Microport Navibot International LLC
10012NB
In Commercial Distribution

  • 10850030914016 ()
  • 00850030914019 ()
10012NB

  • Robotic surgical navigation system
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