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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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STABILIZING COLLET 16MM
ONKOS SURGICAL, INC.
K0051116E
In Commercial Distribution

  • B278K0051116E0 ()
K0051116E

  • General internal orthopaedic fixation system implantation kit
STABILIZING COLLET 24MM
ONKOS SURGICAL, INC.
K0051124E
In Commercial Distribution

  • B278K0051124E0 ()
K0051124E

  • General internal orthopaedic fixation system implantation kit
STABILIZING COLLET 22MM
ONKOS SURGICAL, INC.
K0051122E
In Commercial Distribution

  • B278K0051122E0 ()
K0051122E

  • General internal orthopaedic fixation system implantation kit
STABILIZING COLLET 20MM
ONKOS SURGICAL, INC.
K0051120E
In Commercial Distribution

  • B278K0051120E0 ()
K0051120E

  • General internal orthopaedic fixation system implantation kit
STABILIZING COLLET 18MM
ONKOS SURGICAL, INC.
K0051118E
In Commercial Distribution

  • B278K0051118E0 ()
K0051118E

  • General internal orthopaedic fixation system implantation kit
Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-110
In Commercial Distribution

  • 00814008029822 ()


  • General internal orthopaedic fixation system implantation kit
Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-109
In Commercial Distribution

  • 00814008029815 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: CC Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CCI
In Commercial Distribution

  • 00814008029785 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Awl Small. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-112
In Commercial Distribution

  • 00814008029778 ()


  • General internal orthopaedic fixation system implantation kit
Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-108
In Commercial Distribution

  • 00814008029754 ()


  • General internal orthopaedic fixation system implantation kit
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