BEUDAMED
    1,457 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen PDGFRA RGQ PCR Kit

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 FISH PHARMADX KIT

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS HBSAG CONFIRMATORY TEST

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBS CALCHECK

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·Essure System for Permanent Birth Control

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

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

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·TRIDYNE™ Vascular Sealant

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    FDA Pre-Market Approval
    FDA Class 3 ·Parvovirus B19 IgM Immunoassy (V619IMUS)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM SYSTEM FOR URINARY CONTROL

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS