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
Biomet Orthopedics, LLC
424442
In Commercial Distribution

  • 00880304373556 ()
424442

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Biomet Orthopedics, LLC
423531
In Commercial Distribution

  • 00880304371323 ()
423531

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
AB MEDICA GROUP, S.A.
3021500
In Commercial Distribution

  • 08428763010500 ()


  • Electrocardiographic recording paper
No Description
Zimmer, Inc.
SSI006875
In Commercial Distribution

  • 00889024647091 ()

  • 28 MM
SSI006875

  • Surgical implant/trial-implant/sizer holder, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-102-251
In Commercial Distribution

  • 09348215056810 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 28
In Commercial Distribution

  • 09010522000267 ()
  • 09010522001400 ()
100432

  • Dental implant stability resonance frequency analysis peg
No Description
AB MEDICA GROUP, S.A.
2909003
In Commercial Distribution

  • 08428763008361 ()


  • Electrocardiographic recording paper
Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. It provides basic nutrients for cell maintenance.
AL.CHI.MI.A. SRL
KER 001-00
In Commercial Distribution

  • 08021118001408 ()
  • 18021118001405 ()

  • Total Volume: 20 Milliliter


  • Corneal storage medium
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
51.181.US.BULK5
In Commercial Distribution

  • 04250289513562 ()
51.181.US.BULK5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
51.181.US
In Commercial Distribution

  • 04250289513487 ()
51.181.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
53.120.US
In Commercial Distribution

  • 04250289513401 ()
53.120.US

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
53.100.US
In Commercial Distribution

  • 04250289510394 ()


  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.051.US
Not in Commercial Distribution

  • 04250289510387 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.050.US
In Commercial Distribution

  • 04250289510370 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.101.US
In Commercial Distribution

  • 04250289510363 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.100.US
In Commercial Distribution

  • 04250289510356 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
Aesku.Diagnostics GmbH & Co. KG
51.101.US.Bulk5
In Commercial Distribution

  • 04250289504942 ()
51.101.US.Bulk5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES ANA HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA HEp-2 Test System is intended for use as aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
Aesku.Diagnostics GmbH & Co. KG
51.100.US
In Commercial Distribution

  • 04250289504461 ()
51.100.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
No Description
BIOGENEX LABORATORIES
AN722-5M
In Commercial Distribution

  • 00810119671615 ()

  • Total Volume: 6 Milliliter
AN722-5M

  • CD4 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM539-5M
In Commercial Distribution

  • 00810119670762 ()

  • Total Volume: 6 Milliliter
AM539-5M

  • Glypican-3 IVD, antibody
No Description
BIOGENEX LABORATORIES
AMB05-5M
In Commercial Distribution

  • 00810119670724 ()

  • Total Volume: 6 Milliliter
AMB05-5M

  • Alpha thalassemia/mental retardation syndrome X-linked (ATRX) IVD, antibody
No Description
BIOGENEX LABORATORIES
AM256-5M
In Commercial Distribution

  • 00810119670717 ()

  • Total Volume: 6 Milliliter
AM256-5M

  • Androgen receptor IVD, antibody
No Description
BIOGENEX LABORATORIES
AN723-5M
In Commercial Distribution

  • 00810119670700 ()

  • Total Volume: 6 Milliliter
AN723-5M

  • Bcl-2 oncoprotein IVD, antibody
No Description
BIOGENEX LABORATORIES
AM424-5M
In Commercial Distribution

  • 00810119670694 ()

  • Total Volume: 6 Milliliter
AM424-5M

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
No Description
BIOGENEX LABORATORIES
AM708-5M
In Commercial Distribution

  • 00810119670687 ()

  • Total Volume: 6 Milliliter
AM708-5M

  • Bcl-6 protein IVD, antibody
No Description
BIOGENEX LABORATORIES
AY874-50D
In Commercial Distribution

  • 00810119679840 ()

  • Total Volume: 5 Milliliter
AY874-50D

  • Anaplastic lymphoma kinase IVD, antibody
No Description
BIOGENEX LABORATORIES
AX071-50D
In Commercial Distribution

  • 00810119679833 ()

  • Total Volume: 5 Milliliter
AX071-50D

  • Cytokeratin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM392-10M
In Commercial Distribution

  • 00810119677303 ()

  • Total Volume: 10 Milliliter
AM392-10M

  • Homeobox protein CDX-2 IVD, antibody
No Description
BIOGENEX LABORATORIES
AM236-10M
In Commercial Distribution

  • 00810119677280 ()

  • Total Volume: 10 Milliliter
AM236-10M

  • CD34 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM322-10M
In Commercial Distribution

  • 00810119677273 ()

  • Total Volume: 10 Milliliter
AM322-10M

  • CD3 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX246-YCD
In Commercial Distribution

  • 00810119677266 ()
AX246-YCD

  • Cytokeratin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM302-10M
In Commercial Distribution

  • 00810119676726 ()

  • Total Volume: 10 Milliliter
AM302-10M

  • CD15 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX363-YCD
In Commercial Distribution

  • 00810119676689 ()
AX363-YCD

  • Synaptophysin IVD, antibody
No Description
BIOGENEX LABORATORIES
AX414-YCD
In Commercial Distribution

  • 00810119676665 ()
AX414-YCD

  • CD79a cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX126-YCD
In Commercial Distribution

  • 00810119676610 ()
AX126-YCD

  • Chromogranin A IVD, antibody
No Description
BIOGENEX LABORATORIES
AX232-YCD
In Commercial Distribution

  • 00810119676603 ()
AX232-YCD

  • CD31 endothelial cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX297-YCD
In Commercial Distribution

  • 00810119676559 ()
AX297-YCD

  • Ki67 antigen IVD, antibody
No Description
BIOGENEX LABORATORIES
AX315-YCD
In Commercial Distribution

  • 00810119676528 ()
AX315-YCD

  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX255-YCD
In Commercial Distribution

  • 00810119676511 ()
AX255-YCD

  • Multiple solid tumour differentiation marker IVD, antibody
No Description
BIOGENEX LABORATORIES
MU134-UC
In Commercial Distribution

  • 00810119674876 ()

  • Total Volume: 1 Milliliter
MU134-UC

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
No Description
BIOGENEX LABORATORIES
AR572-5R
In Commercial Distribution

  • 00810119676474 ()

  • Total Volume: 6 Milliliter
AR572-5R

  • Complement component C4d IVD, antibody
No Description
BIOGENEX LABORATORIES
AY887-YCD
In Commercial Distribution

  • 00810119676450 ()
AY887-YCD

  • Thyroid transcription factor-1 (TTF1) IVD, antibody
No Description
BIOGENEX LABORATORIES
AN726-5M
In Commercial Distribution

  • 00810119676443 ()

  • Total Volume: 6 Milliliter
AN726-5M

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
No Description
BIOGENEX LABORATORIES
MU572-UC
In Commercial Distribution

  • 00810119676269 ()

  • Total Volume: 1 Milliliter
MU572-UC

  • Cytokeratin IVD, antibody
No Description
BIOGENEX LABORATORIES
MU009-UC
In Commercial Distribution

  • 00810119675682 ()

  • Total Volume: 1 Milliliter
MU009-UC

  • Carcinoembryonic antigen (CEA) IVD, antibody
No Description
BIOGENEX LABORATORIES
MU421-UC
In Commercial Distribution

  • 00810119675484 ()

  • Total Volume: 1 Milliliter
MU421-UC

  • CD4 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
MU540-UC
In Commercial Distribution

  • 00810119675446 ()

  • Total Volume: 1 Milliliter
MU540-UC

  • p16 antigen IVD, antibody
No Description
BIOGENEX LABORATORIES
MU446-UC
In Commercial Distribution

  • 00810119675149 ()

  • Total Volume: 1 Milliliter
MU446-UC

  • Inhibin A IVD, antibody
No Description
BIOGENEX LABORATORIES
AR125-5R
In Commercial Distribution

  • 00810119672964 ()

  • Total Volume: 6 Milliliter
AR125-5R

  • Toxoplasma gondii total antibody IVD, control
No Description
BIOGENEX LABORATORIES
AN449-5M
In Commercial Distribution

  • 00810119672957 ()

  • Total Volume: 6 Milliliter
AN449-5M

  • p504s protein IVD, antibody
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