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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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NeuroProbe - 07290014954076

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954073 ()
  • 07290014954076 ()
STR-222291-00

  • Depth electrode

NeuroProbe - 07290014954878

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

  • Depth electrode

NeuroProbe - 07290014954861

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954868 ()
  • 07290014954861 ()
STR-000136-00

  • Depth electrode

NeuroProbe - 07290014954311

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954311 ()
  • 17290014954318 ()
STR-000080-00

  • Depth electrode

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

O640 Upgrade - 00840682123730

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

  • 00840682123730 ()


  • Full-body CT system
  • Stationary gamma camera system

OR-VAC - 00815198012748

Surgical Smoke Evacuator
Buffalo Filter
220 V
Not in Commercial Distribution

  • 00815198012748 ()
FOVV220

  • 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 - 00815198012724

Surgical Smoke Evacuator
Buffalo Filter
120V
Not in Commercial Distribution

  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system

OR-VAC - 20845854081775

OR-VAC Adapter for Automatic Activation
Conmed Corporation
OLSONIC
In Commercial Distribution

OLSONIC

  • 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 - 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

Oocyte Collection Tube 14 mL - 17350025914555

No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube

Opaque ULPA Filter & Water Trap - 00817688021490

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

  • 00817688021506 ()
  • 00817688021490 ()


  • Surgical plume evacuation system

Optima - 00840682139281

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

  • 00840682139281 ()


  • Full-body CT system
  • Stationary gamma camera system

Optima NMCT640 - 00840682115285

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JZ
In Commercial Distribution

  • 00840682115285 ()


  • Full-body CT system
  • Stationary gamma camera system

Origin - 09348215007812

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0801
In Commercial Distribution

  • 09348215007812 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001643

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1802
In Commercial Distribution

  • 09348215001643 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001636

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1602
In Commercial Distribution

  • 09348215001636 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001629

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1502
In Commercial Distribution

  • 09348215001629 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001612

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1402
In Commercial Distribution

  • 09348215001612 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001605

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1302
In Commercial Distribution

  • 09348215001605 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001599

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1202
In Commercial Distribution

  • 09348215001599 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001582

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1102
In Commercial Distribution

  • 09348215001582 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001575

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1002
In Commercial Distribution

  • 09348215001575 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001568

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0902
In Commercial Distribution

  • 09348215001568 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001551

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0802
In Commercial Distribution

  • 09348215001551 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001544

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1801
In Commercial Distribution

  • 09348215001544 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001537

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1601
In Commercial Distribution

  • 09348215001537 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001520

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1501
In Commercial Distribution

  • 09348215001520 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001513

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1401
In Commercial Distribution

  • 09348215001513 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001506

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1301
In Commercial Distribution

  • 09348215001506 ()
111-18-130

  • Coated femoral stem prosthesis, modular

Origin - 09348215001490

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1201
In Commercial Distribution

  • 09348215001490 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001483

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1101
In Commercial Distribution

  • 09348215001483 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001476

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1001
In Commercial Distribution

  • 09348215001476 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001469

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0901
In Commercial Distribution

  • 09348215001469 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001452

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1800
In Commercial Distribution

  • 09348215001452 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001445

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1600
In Commercial Distribution

  • 09348215001445 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001438

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1500
In Commercial Distribution

  • 09348215001438 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001421

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1400
In Commercial Distribution

  • 09348215001421 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001414

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1300
In Commercial Distribution

  • 09348215001414 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001407

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1200
In Commercial Distribution

  • 09348215001407 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001391

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1100
In Commercial Distribution

  • 09348215001391 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001384

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1000
In Commercial Distribution

  • 09348215001384 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001377

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0900
In Commercial Distribution

  • 09348215001377 ()


  • Coated femoral stem prosthesis, modular

Origin - 09348215001360

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0800
In Commercial Distribution

  • 09348215001360 ()


  • Coated femoral stem prosthesis, modular

Origin 125° Short Neck Collared Hip Stem - 09348215083564

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0826
In Commercial Distribution

  • 09348215083564 ()


  • Coated femoral stem prosthesis, modular

Origin 125° Short Neck Hip Stem - 09348215083557

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0825
In Commercial Distribution

  • 09348215083557 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024192

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular
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