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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Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564115
In Commercial Distribution

  • 00887761983816 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560118
In Commercial Distribution

  • 00887761983793 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564116
In Commercial Distribution

  • 00887761983823 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564114
In Commercial Distribution

  • 00887761983809 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560117
In Commercial Distribution

  • 00887761983786 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560116
In Commercial Distribution

  • 00887761983779 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560115
In Commercial Distribution

  • 00887761983762 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560114
In Commercial Distribution

  • 00887761983755 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560113
In Commercial Distribution

  • 00887761983748 ()


  • Gait rehabilitation system harness
GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system
GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system
GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
Origin Black Spectacle
Kenmark Optical, Inc.
ORIGBK51
In Commercial Distribution

  • 00715317534703 ()


  • Prescription spectacles
Origin Steel Spectacle
Kenmark Optical, Inc.
ORIGST51
In Commercial Distribution

  • 00715317534680 ()


  • Prescription spectacles
Origin Brown Spectacle
Kenmark Optical, Inc.
ORIGBR53
In Commercial Distribution

  • 00715317534673 ()


  • Prescription spectacles
Origin Brown Spectacle
Kenmark Optical, Inc.
ORIGBR51
In Commercial Distribution

  • 00715317534666 ()


  • Prescription spectacles
Origin Sand Spectacle
Kenmark Optical, Inc.
ORIGSA53
In Commercial Distribution

  • 00715317534734 ()


  • Prescription spectacles
Origin Sand Spectacle
Kenmark Optical, Inc.
ORIGSA51
In Commercial Distribution

  • 00715317534727 ()


  • Prescription spectacles
Origin Black Spectacle
Kenmark Optical, Inc.
ORIGBK53
In Commercial Distribution

  • 00715317534710 ()


  • Prescription spectacles
AN Lordotic - Oblique, Bone Packing Mold,
K2M, INC.
5303-90112
In Commercial Distribution

  • 10888857111523 ()
5303-90112

  • Bone graft packing block
Bone Packing Mold Base
K2M, INC.
1708-90043
In Commercial Distribution

  • 10888857023581 ()
1708-90043

  • Bone graft packing block
Bone Packing Mold, Size 12x17 mm
K2M, INC.
1708-90033
In Commercial Distribution

  • 10888857023529 ()
1708-90033

  • Bone graft packing block
Bone Packing Mold, Size 12x14 mm
K2M, INC.
1708-90032
In Commercial Distribution

  • 10888857023512 ()
1708-90032

  • Bone graft packing block
Bone Packing Mold Size 10 and 12 mm, TL
K2M, INC.
6101-90002
In Commercial Distribution

  • 10888857190870 ()
6101-90002

  • Bone graft packing block
Bone Packing Mold Size 8.5 and 10 mm, AN
K2M, INC.
6101-90000
In Commercial Distribution

  • 10888857190856 ()
6101-90000

  • Bone graft packing block
Bone Packing Mold, Two Sided,
K2M, INC.
5203-90099
In Commercial Distribution

  • 10888857157385 ()
5203-90099

  • Bone graft packing block
No Description
Jeil Medical Corporation
111-299
In Commercial Distribution

  • 08806390885331 ()


  • Bone graft packing block
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.
Instrumentation Difra SA
HeadStar V2.0
In Commercial Distribution

  • B516320980 ()
32098

  • Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516311790 ()
31179

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516227090 ()
22709

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516222210 ()
22221

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.
Instrumentation Difra SA
HeadStar
In Commercial Distribution

  • B516221350 ()
22135

  • Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
Instrumentation Difra SA
NysStar II
In Commercial Distribution

  • B516221340 ()
22134

  • Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR I is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). NYSSTAR I is able to record all eye movements, as well horizontal, as vertical and even rotary movements on option. The calibration carried out by NYSSTAR I is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
Instrumentation Difra SA
NysStar I
In Commercial Distribution

  • B516221280 ()
22128

  • Electronystagmograph
Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block
Tecapro mt.
Innovasis, Inc.
LS-215
In Commercial Distribution

  • M711LS2150 ()
LS-215

  • Bone graft packing block
Bone Graft Block Assembly, Al, SST
Innovasis, Inc.
LAA-040
In Commercial Distribution

  • M711LAA0400 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
PL0450
In Commercial Distribution

  • 08800015954730 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
PE1020
In Commercial Distribution

  • 08800015953986 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
TL0520
In Commercial Distribution

  • 08800015995474 ()


  • Bone graft packing block
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 2XL/3XL
In Commercial Distribution

  • 05391512286408 ()
  • 05391512282820 ()
505

  • Lumbar spine orthosis
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