BEUDAMED
    9,662 results · 49ms · Sources: EU EUDAMED, US FDA

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    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSHESIS

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·ClearVisc Ophthalmic Viscosurgical Device (OVD)

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS FREE PSA IMMUNOASSAY

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    FDA Pre-Market Approval
    FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·NINJA PTCA DILATION CATHETERS

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel Solid Tumors with dMMR status)

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·STORMER ZIPPER MX BALLOON DILATATION CATHETER

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS