Company Name Brand Name GMDN Term 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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LEOPARD SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
286409100
Not in Commercial Distribution

  • 10705034212487 ()
286409100

  • Bone graft packing block
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

  • 30614559104594 ()
  • 10614559104590 ()


  • Surgical plume evacuation system
Base
SpineArt SA
JLL-IN 44 00-N
In Commercial Distribution

  • 07640185342989 ()
JLL-IN 44 00-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
JUT-IN 00 01-N
Not in Commercial Distribution

  • 07640178981638 ()
JUT-IN 00 01-N

  • Bone graft packing block
ANGULATED IMPACTOR
SpineArt SA
JLL-IN 11 02-N
Not in Commercial Distribution

  • 07640178983052 ()
JLL-IN 11 02-N

  • Bone graft packing block
STRAIGHT IMPACTOR
SpineArt SA
JLL-IN 11 01-N
Not in Commercial Distribution

  • 07640178982819 ()
JLL-IN 11 01-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
JLL-IN 08 01-N
In Commercial Distribution

  • 07640178982765 ()
JLL-IN 08 01-N

  • Bone graft packing block
COMPACTOR
SpineArt SA
JUL-IN 14 00-N
In Commercial Distribution

  • 07640151087050 ()
JUL-IN 14 00-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 01 03-N
In Commercial Distribution

  • 07640139349941 ()
DYN-IP 01 03-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block
Compactor
SpineArt SA
DYN-IP 00 02-N
In Commercial Distribution

  • 07640139342416 ()
DYN-IP 00 02-N

  • Bone graft packing block
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)
JAGUAR LUMBAR I/F CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
6000199
In Commercial Distribution

  • 10705034007038 ()
6000199

  • 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
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
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. 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
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
PARKER-HANNIFIN CORPORATION
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
PARKER-HANNIFIN CORPORATION
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
CERVICAL I/F CAGE FILLER BLOCK
DEPUY SPINE, LLC
273301400
In Commercial Distribution

  • 10705034187969 ()
273301400

  • Bone graft packing block
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196270
In Commercial Distribution

  • 00384401018827 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000196270

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196240
In Commercial Distribution

  • 00384401018810 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000196240

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196170
In Commercial Distribution

  • 00384401018803 ()

  • Length: 152 Millimeter
  • Width: 25 Millimeter
M002000196170

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019561P0
In Commercial Distribution

  • 00384401017981 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M00202019561P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019530P0
In Commercial Distribution

  • 00384401017974 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M00202019530P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019585P0
In Commercial Distribution

  • 00384401017967 ()

  • Length: 15.2 Centimeter
  • Width: 0.8 Centimeter
M00202019585P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019579P0
In Commercial Distribution

  • 00384401017950 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M00202019579P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019575P0
In Commercial Distribution

  • 00384401017943 ()

  • Length: 7.6 Centimeter
  • Width: 0.6 Centimeter
M00202019575P0

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195270
In Commercial Distribution

  • 00384401017936 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000195270

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195240
In Commercial Distribution

  • 00384401017929 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000195240

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195170
In Commercial Distribution

  • 00384401017912 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M002000195170

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195090
In Commercial Distribution

  • 00384401017905 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195090

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195140
In Commercial Distribution

  • 00384401017899 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M002000195140

  • Cardiovascular patch, animal-derived
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