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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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Patient Specific Instrument and Planning Kit, Distraction
Materialise NV
SD900.006
In Commercial Distribution

  • 05420060350061 ()
SD900.006

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Midface Reconstruction
Materialise NV
SD900.004
In Commercial Distribution

  • 05420060350047 ()
SD900.004

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Basic Mandible Reconstruction
Materialise NV
SD900.003
In Commercial Distribution

  • 05420060350030 ()
SD900.003

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Mandible Reconstruction
Materialise NV
SD900.001
In Commercial Distribution

  • 05420060350016 ()
SD900.001

  • Custom-made organ/bone anatomy model/surgical guide kit
Heartprint medical model, SLS
Materialise NV
HEAPR-01-001-01
In Commercial Distribution

  • 05420060346019 ()
HEAPR-01-001-01

  • Custom-made organ/bone anatomy model
Heartprint medical model, SLA
Materialise NV
HEAPR-01-002-01
In Commercial Distribution

  • 05420060346002 ()
HEAPR-01-002-01

  • Custom-made organ/bone anatomy model
Lower extremity Guide and Model
Materialise NV
O-01-0-300000-0021-020
In Commercial Distribution

  • 05420060343407 ()
O-01-0-300000-0021-020

  • Custom-made organ/bone anatomy model/surgical guide kit
TRULIFE NATURAL KNEE WITH PYRAMID AND MANUAL LOCK
TRULIFE LIMITED
SSK602L
In Commercial Distribution

  • 00645517842158 ()


  • Knee support orthosis
Matrix Max Raw AFO (One Size Right)
TRULIFE LIMITED
FH225-R
In Commercial Distribution

  • 00645517800240 ()


  • Ankle/foot orthosis
Matrix Max Raw AFO (One Size Left)
TRULIFE LIMITED
FH225-L
In Commercial Distribution

  • 00645517800233 ()


  • Ankle/foot orthosis
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