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
ALPHA OMEGA ENGINEERING CO. LTD.
Remote Control
In Commercial Distribution

  • 07290114064033 ()
700-006011-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage
In Commercial Distribution

  • 07290114064026 ()
750-000020-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Drive Headstage
In Commercial Distribution

  • 07290114064019 ()
700-006000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart NeuroForits Drive Headstage
In Commercial Distribution

  • 07290114062985 ()
700-006010-00

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

  • 07290114062510 ()
750-000070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MER Headstage
In Commercial Distribution

  • 07290114062381 ()
700-005023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage
In Commercial Distribution

  • 07290114062374 ()
700-006009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage
In Commercial Distribution

  • 07290114062367 ()
750-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage
In Commercial Distribution

  • 07290014954991 ()
750-000023-00

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

  • 17290014954882 ()
  • 07290014954885 ()
366-222291-00

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

  • 17290014954851 ()
  • 07290014954854 ()
366-000426-00

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

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

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

  • 07290014954083 ()


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

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

  • Depth electrode
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
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
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450620 ()
  • 17290016450627 ()
366-901079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450613 ()
  • 17290016450610 ()
366-901024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450606 ()
  • 17290016450603 ()
366-009024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450590 ()
  • 17290016450597 ()
366-009079-00

  • Depth electrode
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