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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No Description
BIOMET SPINE LLC
50-6593MP
In Commercial Distribution

  • 00880304948228 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 35MM HF SEAT ASSY
50-6593MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6592MP
In Commercial Distribution

  • 00880304948211 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 30MM HF SEAT ASSY
50-6592MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6591MP
In Commercial Distribution

  • 00880304948204 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 25MM HF SEAT ASSY
50-6591MP

  • Bone-screw internal spinal fixation system, non-sterile
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
AIRLIFE
9446-910
In Commercial Distribution

9446-910

  • Injectate temperature probe
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
AIRLIFE
9446-910
In Commercial Distribution

  • 10190752125612 ()
9446-910

  • Injectate temperature probe
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
Carefusion Finland 320 Oy
9446-910
Not in Commercial Distribution

  • 10885403258374 ()
9446-910

  • Injectate temperature probe
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761588 ()
70335-000210

  • Physiologic-monitoring defibrillation system
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761571 ()
70335-000211

  • Physiologic-monitoring defibrillation system
HELENE CO SET BLK/DEPO_GLD CO/ ASTIN- Frame Material: TR-90 / Metal - Oval Office Wear /Gold Frame Clip On - Lens Technology: Base: DigiTec® Anti-Reflective Coating (Base) Clip: TriLenium® 7 Polarized lens- Sunglasses
Eagle Eyes
22017
In Commercial Distribution

  • 00810712013454 ()
22017

  • Tinted non-prescription spectacle lens
Wired Acquisition System cleared with the Xscribe/Q-Stress Stress System
MORTARA INSTRUMENT, INC.
9293-062-50
In Commercial Distribution

  • 00812345029697 ()


  • Electrocardiographic lead set, reusable
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-35LHS
In Commercial Distribution

  • 08800016401301 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400403 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-65LHS
Not in Commercial Distribution

  • 08800016400380 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016400366 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
PC-ECG Acquisition Device for Resting-ECG recordings with AHA type labelling.
NORAV MEDICAL LTD.
PCECG 1200M
In Commercial Distribution

  • 7290110250782 ()
  • 07290110252854 ()
1200M-D-00U-01

  • Electrocardiographic signal amplifier
PC-ECG Acquisition Device for Resting-ECG recordings with IEC type labelling.
NORAV MEDICAL LTD.
1200M
In Commercial Distribution

  • 07290110252847 ()
1200M-D-00E-01

  • Electrocardiographic signal amplifier
Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
SPECTRUM DYNAMICS MEDICAL, INC
400
In Commercial Distribution

  • 07290108670240 ()
8010427-01

  • SPECT system, annular detector array
Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
SPECTRUM DYNAMICS MEDICAL, INC
300
In Commercial Distribution

  • 07290108670202 ()
8010426-01

  • SPECT system, annular detector array
PC-ECG Acquisition Device with Trigger, 5V operating voltage, FW7, ANALOG
NORAV MEDICAL LTD.
1200T
In Commercial Distribution

  • 07290110255046 ()
1200T2-D-00-06

  • Electrocardiographic signal amplifier
PC-ECG Wireless Acquisition Device for Resting-ECG with IEC type labelling
NORAV MEDICAL LTD.
BlueECG
In Commercial Distribution

  • 07290110250720 ()
BLUECG-D-00E-01

  • Electrocardiography telemetric monitoring system transmitter
No Description
FGX INTERNATIONAL INC.
VH1229557.VER
Not in Commercial Distribution

  • 00612409959355 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1229548.VER
Not in Commercial Distribution

  • 00612409944184 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1229290.VER
Not in Commercial Distribution

  • 00612409942760 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1229281.VER
Not in Commercial Distribution

  • 00612409942753 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1223269.VER
Not in Commercial Distribution

  • 00612409941961 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1223250.VER
Not in Commercial Distribution

  • 00612409941954 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1223241.VER
Not in Commercial Distribution

  • 00612409941947 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
VH1223232.VER
Not in Commercial Distribution

  • 00612409941930 ()


  • Prescription spectacles
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 5
In Commercial Distribution

  • 08809118711059 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 4
In Commercial Distribution

  • 08809118711042 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 2
In Commercial Distribution

  • 08809118711028 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 1
In Commercial Distribution

  • 08809118711011 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
HANSOL Cupping cup_No. 5
In Commercial Distribution

  • 08809118711004 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
HANSOL Cupping cup_No. 4
In Commercial Distribution

  • 08809118710991 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
HANSOL Cupping cup_No. 2
In Commercial Distribution

  • 08809118710977 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
0.20mm x 75mm
In Commercial Distribution

  • 08809118710953 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.40mm x 120mm
In Commercial Distribution

  • 08809118710915 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.40mm x 105mm
In Commercial Distribution

  • 08809118710892 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.40mm x 90mm
In Commercial Distribution

  • 08809118710878 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.40mm x 30mm
In Commercial Distribution

  • 08809118710779 ()
  • 18809118710776 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.35mm x 105mm
In Commercial Distribution

  • 08809118710717 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.35mm x 60mm
In Commercial Distribution

  • 08809118710656 ()
  • 18809118710653 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.35mm x 40mm
In Commercial Distribution

  • 08809118710618 ()
  • 18809118710615 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.30mm x 120mm
In Commercial Distribution

  • 08809118710557 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.30mm x 90mm
In Commercial Distribution

  • 08809118710519 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.30mm x 75mm
In Commercial Distribution

  • 08809118710496 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.30mm x 60mm
In Commercial Distribution

  • 08809118710472 ()
  • 18809118710479 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.25mm x 120mm
In Commercial Distribution

  • 08809118710373 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.25mm x 90mm
In Commercial Distribution

  • 08809118710335 ()


  • Acupuncture needle, single-use
No Description
Hansol Medical Co.
0.25mm x 75mm
In Commercial Distribution

  • 08809118710311 ()


  • Acupuncture needle, single-use
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