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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Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation
No Description
VARIAN MEDICAL SYSTEMS, INC.
3.0
In Commercial Distribution

  • 00856100006158 ()


  • Real-time position management respiratory gating system, optical
  • Linear accelerator system
No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software
0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-040-PL
In Commercial Distribution

  • EIBAVC035040PL0 ()
VC-035-040-PL

  • Radiological image marker, implantable
0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-030-PL
In Commercial Distribution

  • EIBAVC035030PL0 ()
VC-035-030-PL

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-020-PL
In Commercial Distribution

  • EIBAVC035020PL0 ()
VC-035-020-PL

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-010-PL
In Commercial Distribution

  • EIBAVC035010PL0 ()
VC-035-010-PL

  • Radiological image marker, implantable
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