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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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NeuroFortis NeuroSmart Drive HeadStage KIT - 27290114060572

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis NeuroSmart Drive HeadStage KIT
In Commercial Distribution

  • 27290114060572 ()
700-026010-00

  • Depth electrode

Libenger ZD frame Mechanical Set Kit - 27290016450990

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Libenger ZD frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450990 ()
700-020847-00

  • Depth electrode

Leksell Non-XY frame Mechanical Set Kit - 27290016450976

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Leksell Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450976 ()
700-020832-00

  • Depth electrode

CRW Non-XY frame Mechanical Set KIT - 27290016450952

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
CRW Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450952 ()
700-020834-00

  • Depth electrode

Neuro Omega - 27290016450938

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

  • 27290016450938 ()
750-02J013-00

  • Depth electrode

NeuroSmart with AutoClavable Drive Headstage - 27290016450099

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage
In Commercial Distribution

  • 27290016450099 ()
NSW-006008-55

  • Depth electrode

NeuroSmart with NeuroFortis Drive - 27290016450082

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290016450082 ()
NSW-026010-55

  • Depth electrode

NeuroNav with Autoclavable Drive Headstage - 27290016450068

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with Autoclavable Drive Headstage
In Commercial Distribution

  • 27290016450068 ()
NNW-006008-55

  • Depth electrode

NeuroNav with NeuroNav Drive - 27290016450051

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroNav Drive
In Commercial Distribution

  • 27290016450051 ()
NNW-026000-55

  • Depth electrode

NeuroNav with NeuroFortis Drive - 27290016450044

NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive
In Commercial Distribution

  • 27290016450044 ()
NNW-006010-55

  • Depth electrode

Starfix frame Mechanical Set Kit - 27290014954100

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode

Libenger RM frame Mechanical Set KIT - 27290014954094

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Libenger RM frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954094 ()
700-020874-00

  • Depth electrode

Frame adapter thumb screw - Pack of 3 - 37290114061408

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode

LEXO - 09120077180076

The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system

THERA-Trainer lyra - 04041925002775

The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system

Macro Depth Electrode - 00841823109729

No Description
Ad-Tech Medical Instrument Corporation
11
In Commercial Distribution

  • 00841823109729 ()
BF08R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109712

No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109705

No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109699

No Description
Ad-Tech Medical Instrument Corporation
8
In Commercial Distribution

  • 00841823109699 ()
BF09R-SP05X-0BE

  • Depth electrode

Macro Depth Electrode - 00841823109682

No Description
Ad-Tech Medical Instrument Corporation
7
In Commercial Distribution

  • 00841823109682 ()
BF09R-SP21X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109675

No Description
Ad-Tech Medical Instrument Corporation
6
In Commercial Distribution

  • 00841823109675 ()
BF09R-SP61X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109668

No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109651

No Description
Ad-Tech Medical Instrument Corporation
4
In Commercial Distribution

  • 00841823109651 ()
BF10R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109644

No Description
Ad-Tech Medical Instrument Corporation
3
In Commercial Distribution

  • 00841823109644 ()
BF10R-SP61X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109637

No Description
Ad-Tech Medical Instrument Corporation
2
In Commercial Distribution

  • 00841823109637 ()
BF12R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109620

No Description
Ad-Tech Medical Instrument Corporation
1
In Commercial Distribution

  • 00841823109620 ()
BF12R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109613

No Description
Ad-Tech Medical Instrument Corporation
0
In Commercial Distribution

  • 00841823109613 ()
BF12R-SP61X-0C3

  • Depth electrode

Depth Electrode - 00841823109576

No Description
Ad-Tech Medical Instrument Corporation
MM31A-SP53X-000
In Commercial Distribution

  • 00841823109576 ()
MM31A-SP53X-000

  • Depth electrode

Depth Electrode - 00841823109569

No Description
Ad-Tech Medical Instrument Corporation
MM29A-SP52X-000
In Commercial Distribution

  • 00841823109569 ()
MM29A-SP52X-000

  • Depth electrode

Depth Electrode - 00841823109552

No Description
Ad-Tech Medical Instrument Corporation
MM32D-SP05X-000
In Commercial Distribution

  • 00841823109552 ()
MM32D-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109514

No Description
Ad-Tech Medical Instrument Corporation
SD07R-SP45X-0T0
In Commercial Distribution

  • 00841823109514 ()
SD07R-SP45X-0T0

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109507

No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP45X-000
In Commercial Distribution

  • 00841823109507 ()
SD06R-SP45X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109460

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP03X-000
In Commercial Distribution

  • 00841823109460 ()
SD14R-SP03X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109446

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP45X-000
In Commercial Distribution

  • 00841823109446 ()
SD12R-SP45X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109439

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP10X-000
In Commercial Distribution

  • 00841823109439 ()
SD12R-SP10X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109422

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP09X-000
In Commercial Distribution

  • 00841823109422 ()
SD12R-SP09X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109415

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP06X-000
In Commercial Distribution

  • 00841823109415 ()
SD12R-SP06X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109408

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP05X-000
In Commercial Distribution

  • 00841823109408 ()
SD12R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109392

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP03X-000
In Commercial Distribution

  • 00841823109392 ()
SD12R-SP03X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109385

No Description
Ad-Tech Medical Instrument Corporation
SD11R-SP45X-0T0
In Commercial Distribution

  • 00841823109385 ()
SD11R-SP45X-0T0

  • Depth electrode
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