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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No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system
B615 to D630 upgrade kits option with new ROTOR
Hangwei GE Medical Systems Co., Ltd.
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system
D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
NM 615
In Commercial Distribution

  • 00840682139267 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry UPG
In Commercial Distribution

  • 00840682138758 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Biopsy
In Commercial Distribution

  • 00840682138741 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry
In Commercial Distribution

  • 00840682138697 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution

  • 00840682121644 ()


  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
5376496-15
In Commercial Distribution

  • 00840682117869 ()


  • Stationary gamma camera system
UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution

  • 00815962020269 ()


  • Gait rehabilitation frame, electric
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
Mobility Assist
BIODEX MEDICAL SYSTEMS, INC.
950-570
In Commercial Distribution

  • 00718175005705 ()
950-570

  • Gait rehabilitation electronic walker
NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
No Description
HOCOMA AG
V2.0
In Commercial Distribution

  • 07640174660230 ()
31585

  • Mobile gait rehabilitation system, harness-support
BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
BodyMD Gamma Camera System
Not in Commercial Distribution

  • 05711665003026 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003019 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution

  • 05711665002029 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002012 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002005 ()

  • Weight: 815 Kilogram
  • Height: 150 Centimeter
  • Depth: 150 Centimeter
  • Width: 284 Centimeter
9COR2370

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
c.cam Gamma Camera System
In Commercial Distribution

  • 05711665001008 ()

  • Weight: 1350 Kilogram
  • Height: 169 Centimeter
  • Depth: 229 Centimeter
  • Width: 244 Centimeter
9VIR1200

  • Stationary gamma camera system
robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric
Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump
Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump
Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump
Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump
Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump
Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker
Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual
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
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
Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual
Luminaire is a robotic body-weight support system fixed above a slat-belt treadmill. The system provides precise levels of dynamic body-weight support to the patient as they walk on the treadmill, while simultaneously preventing falls. Clinician seating and footplates can be used for situations where manual-assisted ambulation is desired. The Luminaire System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice ambulating on a treadmill. Luminaire should never be used to lift subjects and should never be connected to inanimate objects. Luminaire should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the Luminaire training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
LU-001
In Commercial Distribution

  • 00850018836272 ()


  • Gait rehabilitation frame, electric
ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZG3D-001
In Commercial Distribution

  • 00850018836265 ()


  • Gait rehabilitation frame, electric
The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The BabyG System is intended to assist subjects weighing 50 pounds or less as they practice therapeutic activities related to walking and balance activities. BabyG should never be used to lift and transport subjects and should never be connected to inanimate objects. BabyG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the BabyG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
BG-001
In Commercial Distribution

  • 00850018836258 ()


  • Gait rehabilitation frame, electric
The ZeroG-Lite system is intended to assist patients with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Lite should never be used to lift and transport patients, and should never be connected to inanimate objects. ZeroG-Lite should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG-Lite training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGL-V3
In Commercial Distribution

  • 00850018836234 ()


  • Gait rehabilitation frame, electric
The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
ARETECH, LLC
ZGP-110
In Commercial Distribution

  • 00850018836067 ()


  • Gait rehabilitation frame, manual
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