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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
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210216 ()
  • 04560189210219 ()


  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210209 ()
  • 04560189210202 ()


  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210117 ()
  • 04560189210110 ()


  • Troponin I IVD, kit, enzyme immunoassay (EIA)
Magnetic Resonance Coil
Philips Medical Systems Nederland B.V.
45100004925*
In Commercial Distribution

  • 00884838068407 ()


  • MRI system coil, radio-frequency
Magnetic Resonance Coil
Philips Medical Systems Nederland B.V.
45100004151*
In Commercial Distribution

  • 00884838068377 ()


  • MRI system coil, radio-frequency
Magnetic Resonance Coil
Philips Medical Systems Nederland B.V.
45100004155*
In Commercial Distribution

  • 00884838068322 ()


  • MRI system coil, radio-frequency
Magnetic Resonance Coil
Philips Medical Systems Nederland B.V.
45100004156*
In Commercial Distribution

  • 00884838068315 ()


  • MRI system coil, radio-frequency
No Description
DENTAL MANUFACTURING SPA
ACRY SMART 1 ST 8 LOWER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865121031 ()
  • 28056865121035 ()
0120103

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
ACRY SMART 1 ST 8 UPPER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865121024 ()
  • 28056865121028 ()
0120102

  • Resin artificial teeth
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844116258 ()

  • 18x9x32mm
TRT20180932

  • Metallic spinal interbody fusion cage
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