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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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MyoPro - 00855846007016

The MyoPro, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro to assist the User to initiate and complete desired motions.
Myomo, Inc.
Motion G Right - 25740
In Commercial Distribution

  • 00855846007016 ()
25740

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis

MyoPro - 00855846007009

The MyoPro, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro to assist the User to initiate and complete desired motions.
Myomo, Inc.
Motion G Left - 25736
In Commercial Distribution

  • 00855846007009 ()
25736

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis

HeRO duet - 00865536000234

A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO solo - 00865536000227

A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO ES - 00865536000210

No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO symphony - 00865536000203

Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software

Holter ECG and ABP System - 06944413820500

No Description
Edan Instruments, Inc.
SA-20
In Commercial Distribution

  • 06944413820500 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder

Holter ECG and ABP System - 06944413820494

No Description
Edan Instruments, Inc.
SA-19
In Commercial Distribution

  • 06944413820494 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder

Holter ECG and ABP System - 06944413820487

No Description
Edan Instruments, Inc.
SA-18
In Commercial Distribution

  • 06944413820487 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder

Holter ECG and ABP System - 06944413820470

No Description
Edan Instruments, Inc.
SA-16
In Commercial Distribution

  • 06944413820470 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder

Holter ECG and ABP System - 06944413820463

No Description
Edan Instruments, Inc.
SA-15
In Commercial Distribution

  • 06944413820463 ()


  • Blood pressure ambulatory recorder
  • Electrocardiographic ambulatory recorder

Argus II Operating Room Coil - 00850052743161

No Description
CORTIGENT, INC.
012103-003
Not in Commercial Distribution

012103

  • Retinal prosthesis system tester/clinical evaluator

Argus II Communication Adapter (CA) - 00850052743055

A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
CORTIGENT, INC.
014103-002
Not in Commercial Distribution

014103

  • Retinal prosthesis system tester/clinical evaluator

SwiftPA Software - 00856264005776

Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Clinician Programming System - 00856264005721

Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-006-R
Not in Commercial Distribution

  • 00856264005721 ()
014003

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Glasses Screwdriver - 00856264005523

No Description
Second Sight Medical Products, Inc.
014973-000
Not in Commercial Distribution

  • 00856264005523 ()
014973

  • Retinal prosthesis system tester/clinical evaluator

Argus ll VPU Screwdriver - 00856264005516

No Description
Second Sight Medical Products, Inc.
014972-000
Not in Commercial Distribution

  • 00856264005516 ()
014972

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Camera Rotation Tool - 00856264005509

Tool used to rotate the camera on the glasses during during the camera alignment procedure.
Second Sight Medical Products, Inc.
014993-000
Not in Commercial Distribution

  • 00856264005509 ()
014993

  • Retinal prosthesis system tester/clinical evaluator

Argus ll USB Video Settings Drive - 00856264005493

USB thumb drive containing video settings that can be loaded to the Video Processing Unit.
Second Sight Medical Products, Inc.
014986-001
Not in Commercial Distribution

  • 00856264005493 ()
014986

  • Retinal prosthesis system tester/clinical evaluator

Argus ll USB Transfer Drive - 00856264005486

USB thumb drive for transferring selected files from the Clinician Programming System laptop for data analysis.
Second Sight Medical Products, Inc.
014985-001
Not in Commercial Distribution

  • 00856264005486 ()
014985

  • Retinal prosthesis system tester/clinical evaluator

Argus ll USB Security Drive - 00856264005479

USB thumb drive loaded with security files that contain encrypted login information to enable clinician’s access to the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014984-001
Not in Commercial Distribution

  • 00856264005479 ()
014984

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Touch Screen Monitor - 00856264005462

Used during the camera alignment procedure or other tests to record the patient’s responses.
Second Sight Medical Products, Inc.
014932-001
Not in Commercial Distribution

  • 00856264005462 ()
014932

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Archive Drive - 00856264005455

External USB Drive for archiving of files from the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014931-001
Not in Commercial Distribution

  • 00856264005455 ()
014931

  • Retinal prosthesis system tester/clinical evaluator

Argus ll CPS-CA Cable - 00856264005448

Cable that connects the Clinician Programming System to the Communication Adapter during programming of the Retinal Prosthesis.
Second Sight Medical Products, Inc.
014916-002
Not in Commercial Distribution

  • 00856264005448 ()
014916

  • Retinal prosthesis system tester/clinical evaluator

Argus ll CPS-PTS Cable - 00856264005431

Cable that connects the Clinician Programming System to the Psychophysical Test System during programming of the Retinal Prosthesis.
Second Sight Medical Products, Inc.
014915-001
Not in Commercial Distribution

  • 00856264005431 ()
014915

  • Retinal prosthesis system tester/clinical evaluator

Argus ll CA-VPU Cable - 00856264005424

Cable that connects the Communication Adapter to the Video Processing Unit during programming of Retinal Prosthesis.
Second Sight Medical Products, Inc.
014913-001
Not in Commercial Distribution

  • 00856264005424 ()
014913

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Communication Adapter - 00856264005400

A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
Second Sight Medical Products, Inc.
014103-002
Not in Commercial Distribution

  • 00856264005400 ()
014103

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Clinician Programming System - 00856264005394

Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-004-R
Not in Commercial Distribution

  • 00856264005394 ()
014003

  • Retinal prosthesis system tester/clinical evaluator

NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System - 00850015518294

Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator
ANX ROBOTICA CORP
Controller/ NaviEC-2000
In Commercial Distribution

  • 00850015518294 ()
MC-US-1002

  • Video capsule endoscopy system capsule magnetic manipulation unit

NaviCam Capsule Endoscope System - 00850015518201

Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
ANX ROBOTICA CORP
Controller/NaviEC-1000
In Commercial Distribution

  • 00850015518201 ()
MC-US-1001

  • Video capsule endoscopy system capsule magnetic manipulation unit

Focus - 04650075330074

2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.
NEUROSOFT, OOO
Focus
In Commercial Distribution

  • 04650075330074 ()


  • Electromyograph

N/A - 04961333241903

BULB, HALOGEN
PENTAX OF AMERICA, INC.
2140-0031
In Commercial Distribution

  • 04961333241903 ()


  • Laryngostroboscope system

PillSense Receiver - 05391539210073

The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message “Blood Detected” or “No Blood Detected”.
ENTERASENSE LIMITED
P00167-01FP
In Commercial Distribution

  • 05391539210073 ()


  • Gastrointestinal telemetric monitoring system receiver

SX230FW EMG Sensor - 05060481691512

The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691512 ()
bandwidth 20-460 metal connector

  • Electromyograph

SX230-100 EMG Sensor - 05060481691505

The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691505 ()
Gain 100, bandwidth 20-460 metal connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691499

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-1000Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691499 ()
bandwidth 5-1000 metalconnector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691482

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm..This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-480Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691482 ()
bandwidth 5-480 metal connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691475

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691475 ()
bandwidth 20-460 metal connector

  • Electromyograph

SX230FW EMG Sensor - 05060481691468

The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691468 ()
bandwidth 20-460 plastic connector

  • Electromyograph

SX230-100 EMG Sensor - 05060481691451

The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691451 ()
Gain 100, bandwidth 20-460 plastic connector

  • Electromyograph
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