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
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660254 ()
32001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Nanos V1.2
Not in Commercial Distribution

  • 07640174660216 ()
31001

  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660179 ()
30684

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660162 ()
30683

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660155 ()
30682

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660148 ()
30681

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660117 ()
30005

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660100 ()
30004

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660094 ()
30003

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660063 ()
30000

  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system
The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system
The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D30mm
In Commercial Distribution

  • D960BPX00301 ()
30111610

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D28mm
In Commercial Distribution

  • D960BPX00281 ()
30111609

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D25mm
In Commercial Distribution

  • D960BPX00251 ()
30111608

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D24mm
In Commercial Distribution

  • D960BPX00241 ()
30111607

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D22mm
In Commercial Distribution

  • D960BPX00221 ()
30111606

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D20mm
In Commercial Distribution

  • D960BPX00201 ()
30111605

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D18mm
In Commercial Distribution

  • D960BPX00181 ()
30111604

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D16mm
In Commercial Distribution

  • D960BPX00161 ()
30111603

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm
In Commercial Distribution

  • D960BPX00141 ()
30111602

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D12mm
In Commercial Distribution

  • D960BPX00121 ()
30111601

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D10mm
In Commercial Distribution

  • D960BPX00101 ()
30111600

  • Dental appliance fabrication material, ceramic
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
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
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
robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric
BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution

  • 04056869002729 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system
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