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
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
Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness
No Description
I.C. MEDICAL, INC.
ICM-000-0018
In Commercial Distribution

  • 00817688021735 ()


  • Surgical plume evacuation system
Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual
PSWTURBO 220V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
LU3303-0257
In Commercial Distribution

  • 30845854081291 ()
LU3303-0257

  • Surgical plume evacuation system
PSWTURBO 120V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
LU3303-0255
In Commercial Distribution

  • 30845854081130 ()
LU3303-0255

  • Surgical plume evacuation system
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
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device
LEEP System 1000® Smoke Evacuation System (110 VAC)
Coopersurgical, Inc.
6080-2
In Commercial Distribution

  • 00888937014440 ()


  • Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation System (120 VAC)
Coopersurgical, Inc.
DM53502
In Commercial Distribution

  • 00888937019940 ()


  • Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation (120 VAC)
Coopersurgical, Inc.
53502
In Commercial Distribution

  • 00888937014327 ()


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

  • 10614559104590 ()
  • 30614559104594 ()
2390J

  • Surgical plume evacuation system
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
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
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
JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
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 Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode
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