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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 - 07290014954373

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

  • 07290014954373 ()
  • 17290014954370 ()
STR-000079-00

  • Depth electrode

NeuroProbe - 07290014954366

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

  • 17290014954363 ()
  • 07290014954366 ()
366-000136-00

  • Depth electrode

NeuroProbe - 07290014954359

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

  • 07290014954359 ()
  • 17290014954356 ()
STR-022780-00

  • Depth electrode

NeuroProbe - 07290014954342

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

  • 07290014954342 ()
  • 17290014954349 ()
STR-021480-00

  • Depth electrode

NeuroProbe - 07290014954335

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

  • 07290014954335 ()
  • 17290014954332 ()
STR-007080-00

  • Depth electrode

NeuroProbe - 07290014954328

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

  • 07290014954328 ()
  • 17290014954325 ()
STR-000426-00

  • Depth electrode

NeuroProbe - 07290014954311

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

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

  • Depth electrode

NeuroSmart Main Unit - 07290014954083

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Main Unit
In Commercial Distribution

  • 07290014954083 ()


  • Depth electrode

NeuroProbe - 07290014954076

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

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

  • Depth electrode

NeuroProbe - 07290014954038

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

  • 17290014954035 ()
  • 07290014954038 ()
366-050925-10

  • Depth electrode

DeRoyal - 00749756999274

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756977937

Kit W/Blanket and Gait Belt
DEROYAL INDUSTRIES, INC.
MK3045-UBLG
In Commercial Distribution

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness

DeRoyal - 00749756884440

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168-Y
In Commercial Distribution

  • 00749756884440 ()
M5168-Y

  • Gait rehabilitation system harness

DeRoyal - 00749756866309

Gait Belt, Heavy DutyTiger Teeth Buckle, 2 In X 70 In
DEROYAL INDUSTRIES, INC.
M2572
In Commercial Distribution

  • 50749756866304 ()
  • 00749756866309 ()
M2572

  • Gait rehabilitation system harness

DeRoyal - 00749756861274

GAIT BELT
DEROYAL INDUSTRIES, INC.
M2660
In Commercial Distribution

  • 50749756861279 ()
  • 00749756861274 ()
M2660

  • Gait rehabilitation system harness

DeRoyal - 00749756951784

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness

DeRoyal - 00749756947657

GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness

Leg Harness MasterVest™, Mod. 66 - 00887761984103

Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983847

Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983830

Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983823

Gait rehabilitation system harness
Liko AB
3564116
In Commercial Distribution

  • 00887761983823 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983816

Gait rehabilitation system harness
Liko AB
3564115
In Commercial Distribution

  • 00887761983816 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983809

Gait rehabilitation system harness
Liko AB
3564114
In Commercial Distribution

  • 00887761983809 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983793

Gait rehabilitation system harness
Liko AB
3560118
In Commercial Distribution

  • 00887761983793 ()


  • Gait rehabilitation system harness

Leg Harness MasterVest™, Mod. 66 - 00887761984110

Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness

Leg Harness MasterVest™, Mod. 66 - 00887761984097

Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983786

Gait rehabilitation system harness
Liko AB
3560117
In Commercial Distribution

  • 00887761983786 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983779

Gait rehabilitation system harness
Liko AB
3560116
In Commercial Distribution

  • 00887761983779 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983762

Gait rehabilitation system harness
Liko AB
3560115
In Commercial Distribution

  • 00887761983762 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983755

Gait rehabilitation system harness
Liko AB
3560114
In Commercial Distribution

  • 00887761983755 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983748

Gait rehabilitation system harness
Liko AB
3560113
In Commercial Distribution

  • 00887761983748 ()


  • Gait rehabilitation system harness

DeRoyal - 00749756847865

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672
In Commercial Distribution

  • 50749756847860 ()
  • 00749756847865 ()
M2672

  • Gait rehabilitation system harness

DeRoyal - 00749756783286

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y
In Commercial Distribution

  • 00749756783286 ()
M5166Y

  • Gait rehabilitation system harness

DeRoyal - 00749756782616

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y-72
In Commercial Distribution

  • 00749756782616 ()
M5166Y-72

  • Gait rehabilitation system harness

DeRoyal - 00749756735209

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-B
In Commercial Distribution

  • 50749756735204 ()
  • 00749756735209 ()
M5166-B

  • Gait rehabilitation system harness

Optimal-G - 07290017844312

The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness

ReoAmbulator - 07290017844305

The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness

LiteGait - 00850040235012

LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Mobility Research, Inc.
ALL LiteGait devices
In Commercial Distribution

  • 00850040235012 ()
N/A

  • Gait rehabilitation system harness

SYNCHROMED ® II - 00643169100831

PUMP 8637-20 SYNCHMED II 20ML PF
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169100831 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED ® II - 00643169100824

PUMP 8637-40 SYNCHMED II 40ML PF
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169100824 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

Integra® - 10381780037088

The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode

Auragen™ - 10381780036531

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D5L25
Not in Commercial Distribution

  • M272AU8D5L251 ()
  • 10381780036531 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036524

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L5
Not in Commercial Distribution

  • M272AU8D10L51 ()
  • 10381780036524 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036517

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L25
Not in Commercial Distribution

  • M272AU8D10L251 ()
  • 10381780036517 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036456

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D5L25
Not in Commercial Distribution

  • M272AU6D5L251 ()
  • 10381780036456 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036449

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L5
Not in Commercial Distribution

  • M272AU6D10L51 ()
  • 10381780036449 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036432

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L25
Not in Commercial Distribution

  • M272AU6D10L251 ()
  • 10381780036432 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036326

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D5L25
Not in Commercial Distribution

  • M272AU4D5L251 ()
  • 10381780036326 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036319

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L5
Not in Commercial Distribution

  • M272AU4D10L51 ()
  • 10381780036319 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036302

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L25
Not in Commercial Distribution

  • M272AU4D10L251 ()
  • 10381780036302 ()

  • 4 platinum contacts


  • Depth electrode
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