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
Synapse Biomedical, Inc.
20-0030
In Commercial Distribution

  • 00852184003014 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0031
In Commercial Distribution

  • 00852184003021 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

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

  • 27290016450938 ()
750-02J013-00

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

  • 27290016450877 ()
750-02A016-00

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

  • 07290114063289 ()
750-000025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 6.0
In Commercial Distribution

  • 07290114060882 ()
750-000025-00

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

  • 27290114062484 ()
750-020025-00

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

  • 27290016450211 ()
750-020025-00

  • 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.
Neuro Omega Drive Headstage
In Commercial Distribution

  • 07290114062305 ()
750-000020-00

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

  • 27290114064532 ()
750-020021-00

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

  • 27290114062477 ()
750-020021-00

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

  • 27290114063207 ()
750-020016-00

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

  • 27290016450853 ()
750-02A011-00

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

  • 27290114063214 ()
750-020013-00

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

  • 27290016450167 ()
750-020024-00

  • 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.
Neuro Omega MER Headstage
In Commercial Distribution

  • 07290114062367 ()
750-000023-00

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

  • 27290114062453 ()
750-020024-00

  • 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.
Neuro Omega NeuroFortis Drive Headstage
In Commercial Distribution

  • 07290114060561 ()
750-000070-00

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

  • 07290114061506 ()
NOM-000000-00

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

  • 27290016450846 ()
NOW-020025-00

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

  • 27290114063863 ()
NOW-020025-00

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

  • 27290114064525 ()
NOW-020021-00

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

  • 27290114063856 ()
NOW-020021-00

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

  • 27290114064501 ()
NOW-DF0000-00

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

  • 27290114064518 ()
NOW-DFF000-00

  • Depth electrode
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