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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47.5mm x 14 Contact sEEG Electrode kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
47.5mm x 14 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008276 ()
NSEEG4814

  • Depth electrode
40.5mm x 12 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
40.5mm x 12 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008269 ()
NSEEG4112

  • Depth electrode
33.5mm x 10 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
33.5mm x 10 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008252 ()
NSEEG3410

  • Depth electrode
26.5mm x 8 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
26.5mm x 8 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008245 ()
NSEEG2708

  • Depth electrode
EVO sEEG Electrode 16mm x 5 Contact Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
16mm x 5 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008238 ()
NSEEG1605

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

  • 00817183020684 ()


  • Surgical plume evacuation system
Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube
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
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 18
In Commercial Distribution

  • 08177570205059 ()
PR111-18-1803

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 16
In Commercial Distribution

  • 08177570205042 ()
PR111-18-1603

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 15
In Commercial Distribution

  • 08177570205035 ()
PR111-18-1503

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 14
In Commercial Distribution

  • 08177570205028 ()
PR111-18-1403

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 13
In Commercial Distribution

  • 08177570205011 ()
PR111-18-1303

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 12
In Commercial Distribution

  • 08177570205004 ()
PR111-18-1203

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 11
In Commercial Distribution

  • 08177570204991 ()
PR111-18-1103

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 10
In Commercial Distribution

  • 08177570204984 ()
PR111-18-1003

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 9
In Commercial Distribution

  • 08177570204977 ()
PR111-18-0903

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 8
In Commercial Distribution

  • 08177570204960 ()
PR111-18-0803

  • Coated femoral stem prosthesis, modular
Origin Stem, Coxa Vara Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1804
In Commercial Distribution

  • 08177570200696 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 18 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1802
In Commercial Distribution

  • 08177570200689 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1801
In Commercial Distribution

  • 08177570200672 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1800
In Commercial Distribution

  • 08177570200665 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1604
In Commercial Distribution

  • 08177570200658 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 16 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1602
In Commercial Distribution

  • 08177570200641 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1601
In Commercial Distribution

  • 08177570200634 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1600
In Commercial Distribution

  • 08177570200627 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1504
In Commercial Distribution

  • 08177570200610 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 15 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1502
In Commercial Distribution

  • 08177570200603 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1501
In Commercial Distribution

  • 08177570200597 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1500
In Commercial Distribution

  • 08177570200580 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1404
In Commercial Distribution

  • 08177570200573 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 14 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1402
In Commercial Distribution

  • 08177570200566 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1401
In Commercial Distribution

  • 08177570200559 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1400
In Commercial Distribution

  • 08177570200542 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1304
In Commercial Distribution

  • 08177570200535 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 13 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1302
In Commercial Distribution

  • 08177570200528 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1301
In Commercial Distribution

  • 08177570200511 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1300
In Commercial Distribution

  • 08177570200504 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1204
In Commercial Distribution

  • 08177570200498 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 12 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1202
In Commercial Distribution

  • 08177570200481 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1201
In Commercial Distribution

  • 08177570200474 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1200
In Commercial Distribution

  • 08177570200467 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1104
In Commercial Distribution

  • 08177570200450 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 11 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1102
In Commercial Distribution

  • 08177570200443 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1101
In Commercial Distribution

  • 08177570200436 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1100
In Commercial Distribution

  • 08177570200429 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1004
In Commercial Distribution

  • 08177570200412 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 10 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1002
In Commercial Distribution

  • 08177570200405 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1001
In Commercial Distribution

  • 08177570200399 ()


  • Coated hip femur prosthesis, modular
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