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.
NeuroSmart with AutoClavable Drive Headstage
In Commercial Distribution

  • 27290016450099 ()
NSW-006008-55

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

  • 27290016450082 ()
NSW-026010-55

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

  • 27290016450068 ()
NNW-006008-55

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

  • 27290016450051 ()
NNW-026000-55

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

  • 27290014954100 ()
700-021508-00

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

  • 27290014954094 ()
700-020874-00

  • Depth electrode
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
60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness
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
No Description
Ad-Tech Medical Instrument Corporation
11
In Commercial Distribution

  • 00841823109729 ()
BF08R-SP05X-0BH

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

  • 00841823109712 ()
BF08R-SP21X-0C3

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

  • 00841823109705 ()
BF08R-SP61X-0C3

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

  • 00841823109699 ()
BF09R-SP05X-0BE

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

  • 00841823109682 ()
BF09R-SP21X-0CC

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

  • 00841823109675 ()
BF09R-SP61X-0CC

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

  • 00841823109668 ()
BF10R-SP05X-0BH

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

  • 00841823109651 ()
BF10R-SP21X-0C3

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

  • 00841823109644 ()
BF10R-SP61X-0C3

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

  • 00841823109637 ()
BF12R-SP05X-0BH

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

  • 00841823109620 ()
BF12R-SP21X-0C3

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

  • 00841823109613 ()
BF12R-SP61X-0C3

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

  • 00841823109576 ()
MM31A-SP53X-000

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

  • 00841823109569 ()
MM29A-SP52X-000

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

  • 00841823109552 ()
MM32D-SP05X-000

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

  • 00841823109514 ()
SD07R-SP45X-0T0

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

  • 00841823109507 ()
SD06R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD16R-SP05X-000
In Commercial Distribution

  • 00841823109491 ()
SD16R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP45X-0T1
In Commercial Distribution

  • 00841823109484 ()
SD14R-SP45X-0T1

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP05X-000
In Commercial Distribution

  • 00841823109477 ()
SD14R-SP05X-000

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

  • 00841823109460 ()
SD14R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD13R-SP45X-0T2
In Commercial Distribution

  • 00841823109453 ()
SD13R-SP45X-0T2

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

  • 00841823109446 ()
SD12R-SP45X-000

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

  • 00841823109439 ()
SD12R-SP10X-000

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

  • 00841823109422 ()
SD12R-SP09X-000

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

  • 00841823109415 ()
SD12R-SP06X-000

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

  • 00841823109408 ()
SD12R-SP05X-000

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

  • 00841823109392 ()
SD12R-SP03X-000

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

  • 00841823109385 ()
SD11R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP45X-000
In Commercial Distribution

  • 00841823109378 ()
SD10R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP05X-000
In Commercial Distribution

  • 00841823109354 ()
SD10R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP03X-000
In Commercial Distribution

  • 00841823109347 ()
SD10R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD09R-SP45X-0T0
In Commercial Distribution

  • 00841823109330 ()
SD09R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP45X-000
In Commercial Distribution

  • 00841823109323 ()
SD08R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP10X-AN1
In Commercial Distribution

  • 00841823109316 ()
SD08R-SP10X-AN1

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP10X-000
In Commercial Distribution

  • 00841823109309 ()
SD08R-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP07X-A00
In Commercial Distribution

  • 00841823109293 ()
SD08R-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP05X-000
In Commercial Distribution

  • 00841823109286 ()
SD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP59X-000
In Commercial Distribution

  • 00841823109262 ()
SD06R-SP59X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP10X-000
In Commercial Distribution

  • 00841823109248 ()
SD06R-SP10X-000

  • Depth electrode
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