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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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Healing Innovations - 00860003483206

robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric

HAL for Medical Use - 04560340091091

Number of legs: Double Leg length: eXtra long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution

  • 04560340091091 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091084

Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091077

Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091060

Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090971

Number of legs: Double Leg length: eXtra long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DXMUS
In Commercial Distribution

  • 04560340090971 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090964

Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090957

Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090940

Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton

Symbia_Evo - 04056869001258

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system

Symbia E Single Head System - 04056869002729

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution

  • 04056869002729 ()


  • Stationary gamma camera system

c.cam Imaging System - 04056869001272

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system

Symbia_Evo_Excel - 04056869001265

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system

Symbia S Series - 04056869001166

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system

Symbia E Dual Head System - 04056869001159

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system

ECAM-SCINTRON - 04260484140036

The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system

Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539025

The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton

Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539018

The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton

NM - 00195278788252

830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system

MyoSEPCT ES to MyoSPECT Upgrade - 00195278722546

MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system

MyoSPECT ES - 00195278488626

MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system

MyoSPECT - 00195278488619

MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system

MyoSPECT - 00195278421586

MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system

MyoSPECT ES - 00195278421579

MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • Stationary gamma camera system

Origin DAA Stem, Coxa Vara - 09348215092825

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1804
In Commercial Distribution

  • 09348215092825 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092818

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1604
In Commercial Distribution

  • 09348215092818 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092801

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1504
In Commercial Distribution

  • 09348215092801 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092795

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1404
In Commercial Distribution

  • 09348215092795 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092788

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1304
In Commercial Distribution

  • 09348215092788 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092771

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1204
In Commercial Distribution

  • 09348215092771 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092764

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1104
In Commercial Distribution

  • 09348215092764 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092757

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1004
In Commercial Distribution

  • 09348215092757 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092740

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0904
In Commercial Distribution

  • 09348215092740 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088569

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1813
In Commercial Distribution

  • 09348215088569 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088552

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1812
In Commercial Distribution

  • 09348215088552 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088545

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1613
In Commercial Distribution

  • 09348215088545 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088538

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1612
In Commercial Distribution

  • 09348215088538 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088521

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1513
In Commercial Distribution

  • 09348215088521 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088514

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1512
In Commercial Distribution

  • 09348215088514 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088507

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1413
In Commercial Distribution

  • 09348215088507 ()


  • Coated femoral stem prosthesis, modular
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