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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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Optima - 00840682139281

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT640
In Commercial Distribution

  • 00840682139281 ()


  • Full-body CT system
  • Stationary gamma camera system

Opaque ULPA Filter & Water Trap - 00817688021490

No Description
I.C. MEDICAL, INC.
ICM-000-0434
In Commercial Distribution

  • 00817688021506 ()
  • 00817688021490 ()


  • Surgical plume evacuation system

OR-VAC - 00815198012748

Surgical Smoke Evacuator
Buffalo Filter
220 V
Not in Commercial Distribution

  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system

OR-VAC - 00815198012724

Surgical Smoke Evacuator
Buffalo Filter
120V
Not in Commercial Distribution

  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system

OR-VAC - 00815198012731

Surgical Smoke Evacuator
Buffalo Filter
220V
Not in Commercial Distribution

  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system

OR-VAC - 30845854081048

OR-VAC Surgical Smoke Plume Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
HYVV220
In Commercial Distribution

  • 10845854081044 ()
  • 30845854081048 ()
  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system

OR-VAC - 30845854081031

OR-VAC Surgical Smoke Plume Evacuator with Filter 100V-120V 50/60 Hz
Conmed Corporation
HYVV120
In Commercial Distribution

  • 10845854081037 ()
  • 30845854081031 ()
  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system

OR-VAC - 30845854081024

OR-VAC Surgical Smoke Plume Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
FOVV220
In Commercial Distribution

  • 10845854081020 ()
  • 30845854081024 ()
  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system

O640 Upgrade - 00840682123730

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZC
In Commercial Distribution

  • 00840682123730 ()


  • Full-body CT system
  • 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

NeuroFortis Neuro Omega Drive Headstage KIT - 27290114062439

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis Neuro Omega Drive Headstage KIT
In Commercial Distribution

  • 27290114062439 ()
750-020070-00

  • Depth electrode

Neuro Omega with NeuroFortis Drive Headstage - 27290114062422

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114062422 ()
NOW-020070-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots - 27290114063191

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114063191 ()
NOW-DFF000-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot - 27290114063184

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114063184 ()
NOW-DF0000-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage - 27290114063856

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode

Neuro Omega with AutoClavable Drive Headstage (AutoClavable) - 27290114063863

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063863 ()
NOW-020025-00

  • Depth electrode

Neuro Omega system - 07290114061506

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega system
In Commercial Distribution

  • 07290114061506 ()
NOM-000000-00

  • Depth electrode

Neuro Omega MER Headstage KIT - 27290114062453

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage KIT
In Commercial Distribution

  • 27290114062453 ()
750-020024-00

  • Depth electrode

Neuro Omega EMG HeadBox Kit - 27290114063214

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG HeadBox Kit
In Commercial Distribution

  • 27290114063214 ()
750-020013-00

  • Depth electrode

Neuro Omega EEG Recording Kit - 27290016450853

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EEG Recording Kit
In Commercial Distribution

  • 27290016450853 ()
750-02A011-00

  • Depth electrode

Neuro Omega ECOG HeadBox Kit - 27290114063207

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECOG HeadBox Kit
In Commercial Distribution

  • 27290114063207 ()
750-020016-00

  • Depth electrode

Neuro Omega Drive Headstage Kit - 27290114062477

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage Kit
In Commercial Distribution

  • 27290114062477 ()
750-020021-00

  • Depth electrode

Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable) - 27290114062484

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable)
In Commercial Distribution

  • 27290114062484 ()
750-020025-00

  • Depth electrode

Neuro Omega - 27290016450938

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG- recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450938 ()
750-02J013-00

  • Depth electrode

Neuro Omega - 27290016450877

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • Depth electrode

Neuro Omega - 27290016450891

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

  • Depth electrode

Neptune - 07613327504125

7 m Extension Tubing
STRYKER CORPORATION
0703-045-003
In Commercial Distribution

  • 07613327504125 ()
0703-045-003

  • Surgical plume evacuation system

Neptune - 07613327504118

Grounding Cable
STRYKER CORPORATION
0703-045-002
In Commercial Distribution

  • 07613327504118 ()
0703-045-002

  • Surgical plume evacuation system

Neptune - 07613327466249

SafeAir Compact Smoke Evacuator
STRYKER CORPORATION
0703-045-000
In Commercial Distribution

  • 07613327466249 ()
0703-045-000

  • Surgical plume evacuation system

NMCT - 00840682140843

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
870CZT
In Commercial Distribution

  • 00840682140843 ()


  • Full-body CT system
  • Stationary gamma camera system

NMCT - 00840682140836

870 DR NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00840682140836 ()


  • Stationary gamma camera system
  • Full-body CT system

NMCT - 00840682140775

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
850
In Commercial Distribution

  • 00840682140775 ()


  • Full-body CT system
  • Stationary gamma camera system

NMCT - 00840682140751

NM CT 860 Gantry Final
G E MEDICAL SYSTEMS ISRAEL LTD.
860
In Commercial Distribution

  • 00840682140751 ()


  • Full-body CT system
  • Stationary gamma camera system

NMCT - 00195278788269

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

  • 00195278788269 ()


  • Stationary gamma camera system
  • Full-body CT system

NM - 00840682140829

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system

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

NEBULAE SRS Laparoscopic Surgical Pump - 00817183020684

No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system

NA - 03664539002446

5 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002446 ()
ADP-05

  • Depth electrode

NA - 03664539002422

8 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002422 ()
ADP-08

  • Depth electrode
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