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
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00191
In Commercial Distribution

  • 10888234100621 ()
800-00191

  • Multiple blood group genotyping IVD, reagent
Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J22-050
In Commercial Distribution

  • 00884999027091 ()
07J22-050

  • Cancer/tumour-associated aneuploidy IVD, probe
ProbeChek Low Level Male 95% XX/5% XY
ABBOTT MOLECULAR INC.
07J21-012
In Commercial Distribution

  • 00884999027060 ()
07J21-012

  • Cancer/tumour-associated aneuploidy IVD, probe
ProbeChek Low Level Female 5% XX/95% XY
ABBOTT MOLECULAR INC.
07J21-011
In Commercial Distribution

  • 00884999027053 ()
07J21-011

  • Cancer/tumour-associated aneuploidy IVD, probe
Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J20-050
In Commercial Distribution

  • 00884999027022 ()
07J20-050

  • Cancer/tumour-associated aneuploidy IVD, probe
George King CFD is a Congenital Factor Deficient Convenience Kit which contains five different factor deficient plasma's for product evaluation
GEORGE KING BIO-MEDICAL, INC
0055-5
In Commercial Distribution

  • 00815696021037 ()


  • Coagulation factor XII IVD, reagent
  • Coagulation factor XI IVD, reagent
  • Coagulation factor X IVD, reagent
  • Coagulation factor IX IVD, reagent
  • Coagulation factor VII IVD, reagent
Guidewire
ST. JUDE MEDICAL, INC.
X
In Commercial Distribution

  • 15415067025743 ()
  • 05415067025746 ()

  • Outer Diameter: 0.014 Inch
  • Length: 300 Centimeter
C12309

  • Cardiac/peripheral vascular guidewire, single-use
  • Catheter-tip transducer, pressure
Unit;2.5m, ICG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
X
In Commercial Distribution

  • 09120073931917 ()
00031

  • General-purpose multi-parameter bedside monitor
Unit; External inputs cable for Task Force® Monitor; 2,5m
CNSystems Medizintechnik GmbH
X
Not in Commercial Distribution

  • 09120073931818 ()
HEKA3141

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
X
In Commercial Distribution

  • 09120073931801 ()
00021

  • General-purpose multi-parameter bedside monitor
Clear Dental Aligner
Straight-T LLC
X
In Commercial Distribution

  • 00860005619016 ()


  • Orthodontic aligner auxiliary attachment kit
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 110mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195110 ()

  • Length: 110 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-110

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 100mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195100 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 100 Millimeter
51-2195-100

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 90mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195090 ()

  • Length: 90 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-090

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 80mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195080 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 80 Millimeter
51-2195-080

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 70mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195070 ()

  • Length: 70 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-070

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 60mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195060 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 60 Millimeter
51-2195-060

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 55mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-055

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 50mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195050 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 50 Millimeter
51-2195-050

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 45mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-045

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 40mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195040 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 40 Millimeter
51-2195-040

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 35mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-035

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 30mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195030 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 30 Millimeter
51-2195-030

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 25mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512195025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2195-025

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 110mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095110 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 110 Millimeter
51-2095-110

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 100mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095100 ()

  • Length: 100 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2095-100

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 90mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095090 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 90 Millimeter
51-2095-090

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 80mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095080 ()

  • Length: 80 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2095-080

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 70mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095070 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 70 Millimeter
51-2095-070

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 60mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2095-060

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 55mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095055 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 55 Millimeter
51-2095-055

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 50mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2095-050

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 45mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095045 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 45 Millimeter
51-2095-045

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 40mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2095-040

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 35mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095035 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 35 Millimeter
51-2095-035

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 30mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 9.5 Millimeter
51-2095-030

  • Spinal bone screw, non-bioabsorbable
Taurus Pedicle Screw System- Screw, Pedicle DL Dia 9.5mm x 25mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555512095025 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 25 Millimeter
51-2095-025

  • Spinal bone screw, non-bioabsorbable
Decorticator
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555509000008 ()
50-9000-008

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, 11in
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555503000011 ()

  • Length: 11 Inch
50-3000-011

  • Internal spinal fixation procedure kit, reusable
Caddy, Cross Connector
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555281000059 ()
28-1000-059

  • Device sterilization/disinfection container, reusable
Taurus Pedicle Screw System-Curved Rod 5.5x75mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555252000075 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 75 Millimeter
25-2000-075

  • Bone-screw internal spinal fixation system rod
Taurus Pedicle Screw System-Curved Rod 5.5x85mm
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555252000085 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 80 Millimeter
25-2000-085

  • Bone-screw internal spinal fixation system rod
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
X
In Commercial Distribution

  • 26939550822139 ()
  • 16939550822132 ()
  • 86939550822131 ()


  • Surgical penis clamp, single-use
Pediatric Easy Wrap Apron, Lead, Medium 12" X 29", Royal Blue
Flow X Ray Corporation
66002-20
In Commercial Distribution

  • 00843696125981 ()


  • Radiation shielding apron
Pediatric Easy Wrap Apron, No Lead, Small 10" X 27", Small, Navy Blue
Flow X Ray Corporation
66001TB-22
In Commercial Distribution

  • 00843696125974 ()


  • Radiation shielding apron
Pediatric Easy Wrap Apron Light Weight, Small 10" X 27", Small, Paw Prints
Flow X Ray Corporation
66001LW-34
In Commercial Distribution

  • 00843696125967 ()


  • Radiation shielding apron
Pediatric Easy Wrap Apron Light Weight, Small 10" X 27", Small, Navy Blue
Flow X Ray Corporation
66001LW-22
In Commercial Distribution

  • 00843696125950 ()


  • Radiation shielding apron
Pediatric Easy Wrap Apron, Small 10" X 27", Small, Paw Prints
Flow X Ray Corporation
66001-34
In Commercial Distribution

  • 00843696125943 ()


  • Radiation shielding apron
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