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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Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 30mm
In Commercial Distribution

  • D960LVX00301 ()
30101109

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 28mm
In Commercial Distribution

  • D960LVX00281 ()
30101108

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 25mm
In Commercial Distribution

  • D960LVX00251 ()
30101107

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 24mm
In Commercial Distribution

  • D960LVX00241 ()
30101110

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 22mm
In Commercial Distribution

  • D960LVX00221 ()
30101106

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 20mm
In Commercial Distribution

  • D960LVX00201 ()
30101105

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 18mm
In Commercial Distribution

  • D960LVX00181 ()
30101104

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 16mm
In Commercial Distribution

  • D960LVX00161 ()
30101103

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 14mm
In Commercial Distribution

  • D960LVX00141 ()
30101102

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 12mm
In Commercial Distribution

  • D960LVX00121 ()
30101101

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 10mm
In Commercial Distribution

  • D960LVX00101 ()
30101100

  • Dental appliance fabrication material, ceramic
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JZ
In Commercial Distribution

  • 00840682115285 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT640
In Commercial Distribution

  • 00840682139281 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
I.C. MEDICAL, INC.
ICM-000-0434
In Commercial Distribution

  • 00817688021506 ()
  • 00817688021490 ()


  • Surgical plume evacuation system
No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube
Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block
Surgical Smoke Evacuator
Buffalo Filter
220 V
Not in Commercial Distribution

  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
220V
Not in Commercial Distribution

  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
120V
Not in Commercial Distribution

  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system
OR-VAC Surgical Smoke Plume Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
HYVV220
In Commercial Distribution

  • 10845854081044 ()
  • 30845854081048 ()
  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system
OR-VAC Surgical Smoke Plume Evacuator with Filter 100V-120V 50/60 Hz
Conmed Corporation
HYVV120
In Commercial Distribution

  • 10845854081037 ()
  • 30845854081031 ()
  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system
OR-VAC Surgical Smoke Plume Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
FOVV220
In Commercial Distribution

  • 10845854081020 ()
  • 30845854081024 ()
  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZC
In Commercial Distribution

  • 00840682123730 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061159 ()
700-021507-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexFrame Mechanical Set KIT
In Commercial Distribution

  • 27290016450815 ()
700-021507-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexDrive Electrode Holder - Pack of 2
In Commercial Distribution

  • 27290114061166 ()
700-000316-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexDrive Electrode Holder - Pack of 2
In Commercial Distribution

  • 27290016450242 ()
700-000316-02

  • Depth electrode
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114063016 ()
NSW-026010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290114060435 ()
NSW-026010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290016450082 ()
NSW-026010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063306 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060916 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage
In Commercial Distribution

  • 27290114060442 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage
In Commercial Distribution

  • 27290016450099 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart NeuroForits Drive Headstage
In Commercial Distribution

  • 07290114062985 ()
700-006010-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart NeuroForits Drive Headstage
In Commercial Distribution

  • 07290114060790 ()


  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Main Unit
In Commercial Distribution

  • 07290014954083 ()


  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Main Unit
In Commercial Distribution

  • 07290114061544 ()
700-006007-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage KIT
In Commercial Distribution

  • 27290114063146 ()
700-026009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage
In Commercial Distribution

  • 07290016450019 ()


  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage
In Commercial Distribution

  • 07290114062374 ()
700-006009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER HeadStage Kit
In Commercial Distribution

  • 27290016450150 ()
700-026009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER HeadStage KIT
In Commercial Distribution

  • 27290114060589 ()
700-026009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060930 ()
700-026008-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Autoclavable Drive Headstage Kit
In Commercial Distribution

  • 27290016450228 ()
700-026008-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Autoclavable Drive Headstage KIT
In Commercial Distribution

  • 27290114060596 ()
700-026008-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable)
In Commercial Distribution

  • 27290114063153 ()
700-026008-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Autoclavable Drive Headstage
In Commercial Distribution

  • 07290114063326 ()
700-006008-00

  • Depth electrode
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