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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IMPACTOR X0411310 GRAFT 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411310
In Commercial Distribution

  • 00613994994981 ()


  • Bone graft packing block
PUSHER X0411304 GRAFT MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0411304
In Commercial Distribution

  • 00613994994974 ()


  • Bone graft packing block
PUSHER X0411303 GRAFT SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0411303
In Commercial Distribution

  • 00613994994967 ()


  • Bone graft packing block
LOADING BLOCK EX0311274 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0311274
In Commercial Distribution

  • 00613994992543 ()


  • Bone graft packing block
TROUGH EX0910177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0910177
In Commercial Distribution

  • 00613994933423 ()


  • Bone graft packing block
TROUGH EX0810836 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810836
In Commercial Distribution

  • 00613994933409 ()


  • Bone graft packing block
HOLDER EX1210102 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210102
In Commercial Distribution

  • 00613994922175 ()


  • Bone graft packing block
POSITIONER EX1110248 GRAFT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110248
In Commercial Distribution

  • 00613994922168 ()


  • Bone graft packing block
TROUGH EX1110104 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1110104
In Commercial Distribution

  • 00613994963000 ()


  • Bone graft packing block
Megadyne Speculum Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2395J
In Commercial Distribution

  • 10614559104606 ()
  • 30614559104600 ()
2395J

  • Surgical plume evacuation system
Megadyne Laparoscopic Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2390J
In Commercial Distribution

  • 10614559104590 ()
  • 30614559104594 ()
2390J

  • Surgical plume evacuation system
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block
Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block
Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block
Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution

  • 04260484140074 ()


  • Stationary gamma camera system
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution

  • 04260484140043 ()


  • Stationary gamma camera system
LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Mobility Research, Inc.
ALL LiteGait devices
In Commercial Distribution

  • 00850040235012 ()
N/A

  • Gait rehabilitation system harness
ALIF Graft Block
NEXUS SPINE, L.L.C.
822800
In Commercial Distribution

  • B6788228000 ()


  • Bone graft packing block
Cervical Graft Block
NEXUS SPINE, L.L.C.
822228
In Commercial Distribution

  • B6788222280 ()


  • Bone graft packing block
Steerable Graft Block
NEXUS SPINE, L.L.C.
822130
In Commercial Distribution

  • B6788221300 ()


  • Bone graft packing block
Lumbar Graft Block
NEXUS SPINE, L.L.C.
822005
In Commercial Distribution

  • B6788220050 ()


  • Bone graft packing block
Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491846 ()
  • 00385489491847 ()
49184

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube
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
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
Rod Template. 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-107
In Commercial Distribution

  • 00814008029747 ()


  • General internal orthopaedic fixation system implantation kit
Linear Persuader Counter Torque. 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-105
In Commercial Distribution

  • 00814008026289 ()


  • General internal orthopaedic fixation system implantation kit
Drill, for 7.5MM. 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-043
In Commercial Distribution

  • 00814008026265 ()


  • General internal orthopaedic fixation system implantation kit
Drill, for 6.5MM. 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-042
In Commercial Distribution

  • 00814008026258 ()


  • General internal orthopaedic fixation system implantation kit
Open Head Turner. 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-074
In Commercial Distribution

  • 00814008026227 ()


  • General internal orthopaedic fixation system implantation kit
Open Rod De-Rotator. 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-073
In Commercial Distribution

  • 00814008026210 ()


  • General internal orthopaedic fixation system implantation kit
Open Rod Holder. 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-068
In Commercial Distribution

  • 00814008026166 ()


  • General internal orthopaedic fixation system implantation kit
Open (Counter) Anti-Torque. 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-067
In Commercial Distribution

  • 00814008026159 ()


  • General internal orthopaedic fixation system implantation kit
Open Rod Rocker. 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-066
In Commercial Distribution

  • 00814008026142 ()


  • General internal orthopaedic fixation system implantation kit
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