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
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275008
In Commercial Distribution

  • 04056869001180 ()


  • SPECT/CT system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275007
In Commercial Distribution

  • 04056869001173 ()


  • SPECT/CT system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10853499
Not in Commercial Distribution

  • 04056869001074 ()


  • Radiological PACS software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution

  • 04056869001067 ()


  • Radiological PACS software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10043260
In Commercial Distribution

  • 04056869001050 ()

  • Catheter Gauge: 10 French


  • Intracardiac ultrasound imaging catheter, steerable, single-use
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10135910
In Commercial Distribution

  • 04056869001043 ()

  • Catheter Gauge: 8 French


  • Intracardiac ultrasound imaging catheter, steerable, single-use
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10043342
In Commercial Distribution

  • 04056869001036 ()

  • Catheter Gauge: 10 French


  • Intracardiac ultrasound imaging catheter, steerable, single-use
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10135936
In Commercial Distribution

  • 04056869001029 ()

  • Catheter Gauge: 8 French


  • Intracardiac ultrasound imaging catheter, steerable, single-use
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08255790
In Commercial Distribution

  • 04056869001012 ()

  • Catheter Gauge: 10 French


  • Intracardiac ultrasound imaging catheter, steerable, single-use
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11669400
In Commercial Distribution

  • 04068151012477 ()


  • General-purpose ultrasound imaging system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11575216
In Commercial Distribution

  • 04068151010022 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10751221
In Commercial Distribution

  • 04068151007930 ()


  • Nuclear medicine phantom, test object
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10751224
In Commercial Distribution

  • 04068151007923 ()


  • Nuclear medicine phantom, test object
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11713064
In Commercial Distribution

  • 04068151001303 ()


  • General-purpose ultrasound imaging system
Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873632
In Commercial Distribution

  • 00630414167848 ()
  • 00842768018978 ()
10873632

  • Plasma protein IVD, calibrator
Quantitative determination of cystatin C in human serum and lithium-heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873631
In Commercial Distribution

  • 00630414167824 ()
OQNM19

  • Cystatin C IVD, kit, nephelometry/turbidimetry
IMMULITE 2000 Progesterone Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901873
In Commercial Distribution

  • 00630414167718 ()
L2KPW2(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay
Quantitative determination of free light chains (FLC) type lambda in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10873630
In Commercial Distribution

  • 00630414167664 ()
  • 00630414229089 ()
OPJB07

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Quantitative determination of free light chains (FLC) type kappa in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10873629
In Commercial Distribution

  • 00630414167657 ()
  • 00630414229072 ()
OPJA075

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
IMMULITE 2000 Progesterone Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901874
In Commercial Distribution

  • 00630414167510 ()
L2KPW6(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Prolactin Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901869
In Commercial Distribution

  • 00630414167503 ()
L2KPR6(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Prolactin Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901868
In Commercial Distribution

  • 00630414167497 ()
L2KPR2(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 LH Kt Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901864
In Commercial Distribution

  • 00630414167480 ()
L2KLH6(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 LH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901863
In Commercial Distribution

  • 00630414167459 ()
L2KLH2(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 FSH Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901859
In Commercial Distribution

  • 00630414167442 ()
L2KFS6(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 FSH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901852
In Commercial Distribution

  • 00630414167435 ()
L2KFS2(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 DHEAS Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901849
In Commercial Distribution

  • 00630414167428 ()
L2KDS2(D)

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Crotisol Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901845
In Commercial Distribution

  • 00630414167411 ()
L2KCO6(D)

  • Total cortisol IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Cortisol Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901844
In Commercial Distribution

  • 00630414167404 ()
L2KCO2(D)

  • Total cortisol IVD, kit, chemiluminescent immunoassay
rPru av 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471072
In Commercial Distribution

  • 00630414006345 ()
A597L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rMal d 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471077
In Commercial Distribution

  • 00630414006291 ()
A796L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
nPru p 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368596
In Commercial Distribution

  • 00630414006284 ()
A603L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rPru av 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471075
In Commercial Distribution

  • 00630414006277 ()
A600L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rPru av 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471074
In Commercial Distribution

  • 00630414006253 ()
A599L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rMal d 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10483381
In Commercial Distribution

  • 00630414006246 ()
A464L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
11254820
In Commercial Distribution

  • 00630414002903 ()
OVIA112

  • Nephelometry immunoassay analyser IVD
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