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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Patient Specific Talus Spacer, Small, CoCr
Paragon 28, Inc.
AOPSTSXXXXS
In Commercial Distribution

  • 00889795137210 ()
AOPSTSXXXXS

  • Coated ankle talus prosthesis
Patient Specific Talus Spacer, Nominal, CoCr
Paragon 28, Inc.
AOPSTSXXXXN
In Commercial Distribution

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis
Patient Specific Talus Spacer, Large, CoCr
Paragon 28, Inc.
AOPSTSXXXXL
In Commercial Distribution

  • 00889795137197 ()
AOPSTSXXXXL

  • Coated ankle talus prosthesis
Patient Specific Talus Trial, Large, Nylon
Paragon 28, Inc.
AOPSTT-XXXXL
In Commercial Distribution

  • 00889795128782 ()
AOPSTT-XXXXL

  • Coated ankle talus prosthesis
Patient Specific Talus Trial, Nominal, Nylon
Paragon 28, Inc.
AOPSTT-XXXXN
In Commercial Distribution

  • 00889795128775 ()
AOPSTT-XXXXN

  • Coated ankle talus prosthesis
Patient Specific Talus Trial, Small, Nylon
Paragon 28, Inc.
AOPSTT-XXXXS
In Commercial Distribution

  • 00889795128768 ()
AOPSTT-XXXXS

  • Coated ankle talus prosthesis
Patient Specific Talus Spacer, Small, Titanium
Paragon 28, Inc.
AOPSTSXXXXS-TI
In Commercial Distribution

  • 00889795128133 ()
AOPSTSXXXXS-TI

  • Coated ankle talus prosthesis
Patient Specific Talus Spacer, Nominal, Titanium
Paragon 28, Inc.
AOPSTSXXXXN-TI
In Commercial Distribution

  • 00889795128126 ()
AOPSTSXXXXN-TI

  • Coated ankle talus prosthesis
Patient Specific Talus Spacer, Large, Titanium
Paragon 28, Inc.
AOPSTSXXXXL-TI
In Commercial Distribution

  • 00889795128119 ()
AOPSTSXXXXL-TI

  • Coated ankle talus prosthesis
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 39 NO DISTAL TIP Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 4.3 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
Medos International Sàrl
ENF403900
In Commercial Distribution

  • 10886704075400 ()
ENF403900

  • Bare-metal intracranial vascular stent
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